Wechselwirkungen von Tacrolimus

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Avoid alcoholic beverages. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent. (Fachinformation zu Amiodaron, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. (Fachinformation zu Azithromycin, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

About 13 percent of the cases of neutropenia have ended fatally, but almost all fatalities were in patients with serious illness, having collagen vascular disease, renal failure, heart failure or immunosuppressant therapy, or a combination of these complicating factors. (Fachinformation zu Captopril, Warnhinweise)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. (Fachinformation zu Ciprofloxacin, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Immunosuppressant/neoplastic: everolimus Co-administration of everolimus and PREZISTA/ritonavir is not recommended. irinotecan Discontinue PREZISTA/ritonavir at least 1 week prior to starting irinotecan therapy. (Fachinformation zu Darunavir, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Use with Drugs that Prolong QT Interval and Antiarrhythmic Agents The use of dofetilide in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended. (Fachinformation zu Dofetilid, Warnhinweise)

Concomitant use of COMPLERA with drugs with a known risk to prolong the QTc interval of the electrocardiogram may increase the risk of Torsade de Pointes. (Fachinformation zu Emtricitabin, Rilpivirin und Tenofovir, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (Fachinformation zu Fluconazol, Gegenanzeigen)

Chicken pox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. (Fachinformation zu Fludrocortison, Warnhinweise)

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. (Fachinformation zu Flunisolid, Vorsichtsmaßnahmen)

Because of foscarnet's tendency to cause renal impairment, the use of FOSCAVIR should be avoided in combination with potentially nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, acyclovir, methotrexate, tacrolimus and intravenous pentamidine (see above) unless the potential benefits outweigh the risks to the patient. (Fachinformation zu Foscarnet, Arzneimittelwechselwirkungen)

Avoid co-administration of CONTEPO with drugs known to prolong the QT interval. (Fachinformation zu Fosfomycin, Arzneimittelwechselwirkungen)

Avoid grapefruit or grapefruit juice. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Therefore, PLAQUENIL is not recommended in patients taking other drugs that have the potential to prolong the QT interval. (Fachinformation zu Hydroxychloroquin, Warnhinweise und Vorsichtsmaßnahmen)

Avoid the use of FANAPT in combination with any other drugs that prolong the QT interval [see Warnings and Precautions (5.3) ] . (Fachinformation zu Iloperidon, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Immunosuppressants Everolimus Sirolimus Temsirolimus (IV) Not recommended during and 2 weeks after TOLSURA treatment. (Fachinformation zu Itraconazol, Arzneimittelwechselwirkungen)

Bradycardia may increase the risk of QT prolongation which may lead to severe ventricular arrhythmias, including torsade de pointes, especially in patients with risk factors such as use of QTc prolonging drugs [see Adverse Reactions ( 6.2 )] . (Fachinformation zu Ivabradin, Warnhinweise und Vorsichtsmaßnahmen)

Johanniskraut kann diese Arzneimittel abschwächen, indem es ihren Abbau beschleunigt, was Organabstoßung, Blutgerinnsel oder Wirkverlust bedeuten kann. (NCCIH, St. John's Wort)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval ( 5.11 , 8.5 ) (Fachinformation zu Levofloxacin, Warnhinweise und Vorsichtsmaßnahmen)

Avoid use in patients with congenital long QT syndrome, those with hypokalemia, and with other drugs that prolong the QT interval. (Fachinformation zu Lopinavir und Ritonavir, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…as simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. [See Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] Patients receiving systemic corticosteroids for lifesaving… (Fachinformation zu Mifepriston, Gegenanzeigen)

Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with REMERON/REMERONSolTab, increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). (Fachinformation zu Mirtazapin, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…methylergonovine • HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use [see Table 2 , Drug Interactions (7.3) ] ) • Immunosuppressants: voclosporin • Microsomal triglyceride transfer protein inhibitor: lomitapide • Migraine medications: eletriptan, ubrogepant • Mineralocorticoid receptor antagonists:… (Fachinformation zu Nirmatrelvir und Ritonavir, Gegenanzeigen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Avoid coadministration of oxaliplatin injection with medicinal products with a known potential to prolong the QT interval. (Fachinformation zu Oxaliplatin, Arzneimittelwechselwirkungen)

Avoid coadministration of VOTRIENT with drugs known to prolong the QT/QTc interval. (Fachinformation zu Pazopanib, Arzneimittelwechselwirkungen)

Drugs that Prolong the QT Interval : Avoid concomitant use. (Fachinformation zu Phenobarbital, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Because pimozide prolongs the QT interval of the electrocardiogram it is contraindicated in patients with congenital long QT syndrome, patients with a history of cardiac arrhythmias, patients taking other drugs which prolong the QT interval of the electrocardiogram or patients with known hypokalemia or hypomagnesemia (see also PRECAUTIONS - DRUG INTERACTIONS ). (Fachinformation zu Pimozid, Gegenanzeigen)

The use of WAKIX should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval [see Drug Interactions ( 7.1 )]. (Fachinformation zu Pitolisant, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Nephrotoxicity and leukoencephalopathy (including deaths) have been reported in clinical efficacy studies in patients with elevated cyclosporine or tacrolimus concentrations. (Fachinformation zu Posaconazol, Warnhinweise und Vorsichtsmaßnahmen)

• Avoid use with other antiarrhythmic agents or drugs that prolong the QT interval. (Fachinformation zu Propafenon, Warnhinweise und Vorsichtsmaßnahmen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Avoid the concomitant use of drugs known to prolong the QTc interval. (Fachinformation zu Sertralin, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Certain conditions may increase the risk for torsade de pointes or sudden death such as (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval [see Warnings and Precautions ( 5.8 ), Clinical Pharmacology (12.2) ]. (Fachinformation zu Tetrabenazin, Arzneimittelwechselwirkungen)

CONTRAINDICATIONS Thioridazine hydrochloride tablet use should be avoided in combination with other drugs that are known to prolong the QTc interval and in patients with congenital long QT syndrome or a history of cardiac arrhythmias. (Fachinformation zu Thioridazin, Gegenanzeigen)

Therefore, serum concentrations of the calcineurin inhibitor should be monitored during treatment with TYGACIL to avoid drug toxicity. (Fachinformation zu Tigecyclin, Arzneimittelwechselwirkungen)

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

…IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS • Increased risk for developing serious infections and malignancies with ASTAGRAF XL ® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] • Increased mortality in female liver transplant patients with ASTAGRAF XL. (Fachinformation zu Tacrolimus, Boxed Warning (umrahmter Warnhinweis))

Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval. (Fachinformation zu Vepdegestrant, Warnhinweise und Vorsichtsmaßnahmen)

Therefore, ziprasidone should not be given with: • dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus. (Fachinformation zu Ziprasidon, Gegenanzeigen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Concomitant use of agents associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin receptor blockers) may increase the risk for hyperkalemia [see Adverse Reactions ( 6.1 )] . (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

However, this is of special importance in patients at risk of or having underlying renal dysfunction and patients taking concomitant nephrotoxic agents such as cyclosporine, tacrolimus, aminoglycosides, vancomycin and non-steroidal anti-inflammatory drugs [See Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ]. (Fachinformation zu Adefovir, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Effect of P-glycoprotein (P-gp) Inhibitors and Inducers Concomitant taking of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib [see Clinical Pharmacology (12.3) ]. (Fachinformation zu Afatinib, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Tacrolimus Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. (Fachinformation zu Anidulafungin, Arzneimittelwechselwirkungen)

Other drugs, such as: Magnesium and aluminum hydroxide antacids Metoclopramide May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

MAO inhibitors, tricyclic antidepressants and drugs that prolong the QTc interval may potentiate effect on the cardiovascular system. (Fachinformation zu Arformoterol, Arzneimittelwechselwirkungen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML. (Fachinformation zu Bendamustin, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Drugs that Prolong the QT interval QT prolongation has been reported with metronidazole, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, particularly when administered with drugs with the potential for prolonging the QT interval. (Fachinformation zu Bismutsubcitrat, Metronidazol und Tetracyclin, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Concomitant use of agents associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin receptor blockers) may increase the risk for hyperkalemia [see Adverse Reactions ( 6.1 )] . (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk of combining buprenorphine with other QT-prolonging agents is not known. (Fachinformation zu Buprenorphin, Warnhinweise und Vorsichtsmaßnahmen)

The risk of combining buprenorphine with other QT-prolonging agents is not known. (Fachinformation zu Buprenorphin und Naloxon, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Cannabidiol Drug Interactions When cannabidiol and ASTAGRAF XL are co-administered, closely monitor for an increase in tacrolimus blood levels and for adverse reactions suggestive of tacrolimus toxicity. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Caspofungin May decrease tacrolimus whole blood trough concentrations. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Cannabidiol Drug Interactions When cannabidiol and ASTAGRAF XL are co-administered, closely monitor for an increase in tacrolimus blood levels and for adverse reactions suggestive of tacrolimus toxicity. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

QT Interval Prolongation and V entricular A rr h ythmia Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. (Fachinformation zu Cinacalcet, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Avoid use of Citalopram Capsules in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. (Fachinformation zu Citalopram, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

…droperidol, pimozide), specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmic medications (e.g., quinidine, procainamide) or Class III antiarrhythmics (e.g., amiodarone, sotalol), and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). (Fachinformation zu Clozapin, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections. (Fachinformation zu Denosumab, Warnhinweise und Vorsichtsmaßnahmen)

Carefully monitor cardiac rhythm when administering SUPRANE to susceptible patients (e.g., patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval). (Fachinformation zu Desfluran, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19 . (Fachinformation zu Dexlansoprazol, Arzneimittelwechselwirkungen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…cardiac disease, 3) treatment with Class I and Class III antiarrhythmics, 4) treatment with monoamine oxidase inhibitors (MAOI's), 5) concomitant treatment with other drug products known to prolong the QT interval (see PRECAUTIONS, Drug Interactions ), and 6) electrolyte imbalance, in particular hypokalemia and hypomagnesemia, or concomitant treatment with drugs… (Fachinformation zu Droperidol, Warnhinweise)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inhibitors c : Protease inhibitors (e.g., nelfinavir, telaprevir, boceprevir, ritonavir), azole antifungals (e.g., voriconazole, posaconazole, itraconazole, ketoconazole), antibiotics (e.g., clarithromycin, troleandomycin, chloramphenicol), nefazodone, letermovir, Schisandra sphenanthera extracts May increase tacrolimus whole blood trough concentrations… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index such as cyclosporine, everolimus, sirolimus and tacrolimus, caution and appropriate monitoring should be used [see Clinical Pharmacology (12.3) ] . (Fachinformation zu Elexacaftor, Tezacaftor und Ivacaftor, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. (Fachinformation zu Eribulin, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. (Fachinformation zu Esomeprazol, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration of renal… (Fachinformation zu Fenofibrat, Arzneimittelwechselwirkungen)

Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route… (Fachinformation zu Fenofibrinsäure, Arzneimittelwechselwirkungen)

…prolonged QT interval, 3) treatment with Class 1 and Class III antiarrhythmics, 4) treatment with monoamine oxidase inhibitors (MAOI's), 5) concomitant treatment with other drug products known to prolong the QT interval and 6) electrolyte imbalance, in particular hypokalemia and hypomagnesemia, or concomitant treatment with drugs (e.g., diuretics) that may cause electrolyte… (Fachinformation zu Fentanyl, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Use with caution in combination with other drugs that prolong the QT interval ( 4.2 , 5.11 , 7.7 , 7.8 ) 7.1 Monoamine Oxidase Inhibitors (MAOI) [See Dosage and Administration ( 2.9 , 2.10 ), Contraindications ( 4.1 ), and Warnings and Precautions ( 5.2 )] . (Fachinformation zu Fluoxetin, Arzneimittelwechselwirkungen)

…Antidepressants, QTc Prolonging Drugs Formoterol, as with other beta 2 -agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. (Fachinformation zu Formoterol, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. (Fachinformation zu Goserelin, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

This observation should be considered in making clinical decisions regarding patient monitoring when prescribing HYSINGLA ER in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that are known to prolong the QTc interval. (Fachinformation zu Hydrocodon, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Monitor QT interval when administering FORANE to susceptible patients (e.g., patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval). (Fachinformation zu Isofluran, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

TYKERB may prolong the QT interval in some patients. (Fachinformation zu Lapatinib, Warnhinweise und Vorsichtsmaßnahmen)

HBV reactivation has also been reported in patients receiving certain immunosuppressants or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients. (Fachinformation zu Ledipasvir und Sofosbuvir, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. (Fachinformation zu Leuprorelin, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Other Drugs that Prolong the QTc Interval Coadministration of other drugs known to alter cardiac conduction (e.g., anti-arrhythmic or beta-adrenergic blocking agents, calcium channel blockers, antihistamines or H 1 -blocking agents, tricyclic antidepressants and phenothiazines) might also contribute to a prolongation of the QTc interval. (Fachinformation zu Mefloquin, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inducers Methylprednisolone, prednisone May decrease tacrolimus whole blood trough concentrations. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Other drugs, such as: Magnesium and aluminum hydroxide antacids Metoclopramide May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Drugs that Prolong the QT Interval QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. (Fachinformation zu Metronidazol, Arzneimittelwechselwirkungen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Effect of Micafungin in Sodium Chloride Injection on Other Drugs CYP3A4 Substrates There was no effect of single or multiple doses of micafungin for injection on cyclosporine, tacrolimus, prednisolone, voriconazole and fluconazole pharmacokinetics. (Fachinformation zu Micafungin, Arzneimittelwechselwirkungen)

Strong CYP3A Inhibitors c : Protease inhibitors (e.g., nelfinavir, telaprevir, boceprevir, ritonavir), azole antifungals (e.g., voriconazole, posaconazole, itraconazole, ketoconazole), antibiotics (e.g., clarithromycin, troleandomycin, chloramphenicol), nefazodone, letermovir, Schisandra sphenanthera extracts May increase tacrolimus whole blood trough concentrations… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

…grapefruit juice is a strong CYP3A inhibitor; low dose or single strength grapefruit juice is a moderate CYP3A inhibitor. c Strong CYP3A inhibitor/inducer, based on reported effect on exposures to tacrolimus along with supporting in vitro CYP3A inhibitor/inducer data, or based on drug-drug interaction studies with midazolam (sensitive CYP3A probe substrate). (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Pharmacokinetic studies between moxifloxacin and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. (Fachinformation zu Moxifloxacin, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Tacrolimus Clinical Impact : Concomitant use of esomeprazole magnesium and tacrolimus may increase exposure of tacrolimus Intervention : During concomitant use of naproxen and esomeprazole magnesium delayed-release tablets and tacrolimus, monitor tacrolimus whole blood concentrations. (Fachinformation zu Naproxen und Esomeprazol, Arzneimittelwechselwirkungen)

In another drug-drug interaction study in healthy volunteers, co-administration of LOKELMA 15 g decreased the systemic exposures of tacrolimus (Figure 2), likely due to LOKELMA’s action on elevating gastric pH. (Fachinformation zu Natrium-Zirconium-Cyclosilicat, Arzneimittelwechselwirkungen)

Other drugs, such as: Magnesium and aluminum hydroxide antacids Metoclopramide May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Calcium-channel blocking agents may increase tacrolimus blood concentrations and require dosage reduction of ASTAGRAF XL [see Drug Interactions ( 7.2 )] . (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Use olanzapine and fluoxetine capsules with caution in combination with other drugs that prolong the QT interval ( 4.2 , 5.20 , 7.7 , 7.8 ) 7.1 Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration ( 2.4 , 2.5 ), Contraindications ( 4.1 ), and Warnings and Precautions ( 5.6 )] . (Fachinformation zu Olanzapin und Fluoxetin, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

…or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval. (Fachinformation zu Paliperidon, Warnhinweise und Vorsichtsmaßnahmen)

Drugs that Prolong QT: Use with caution in patients who are at significant risk of developing QTc prolongation. (Fachinformation zu Pasireotid, Arzneimittelwechselwirkungen)

Treatment has consisted of high doses of corticosteroids alone or, in some cases, concomitantly with an immunosuppressant. (Fachinformation zu Penicillamin, Warnhinweise)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inducers Methylprednisolone, prednisone May decrease tacrolimus whole blood trough concentrations. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

QT Interval Prolonging Drugs The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between Primaquine phosphate Tablets and other drugs that effect cardiac conduction is unknown. (Fachinformation zu Primaquin, Arzneimittelwechselwirkungen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

…Class 1A antiarrythmics (e.g., quinidine, procainamide) or Class III antiarrythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone). (Fachinformation zu Quetiapin, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19 . (Fachinformation zu Rabeprazol, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

In healthy subjects, 75 mg once daily and 300 mg once daily (3 times and 12 times the dose in EDURANT) have been shown to prolong the QTc interval of the electrocardiogram. (Fachinformation zu Rilpivirin, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

QT Interval Prolongation The overall analysis of ECG data in pediatric patients indicates that the concomitant use of Rocuronium Bromide Injection with general anesthetic agents can prolong the QTc interval [see Clinical Studies ( 14.3 )]. (Fachinformation zu Rocuronium, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ] . (Fachinformation zu Sevelamer, Arzneimittelwechselwirkungen)

Caution should be exercised when administering sevoflurane to susceptible patients (e.g., patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval). (Fachinformation zu Sevofluran, Warnhinweise)

HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients. (Fachinformation zu Sofosbuvir und Velpatasvir, Warnhinweise und Vorsichtsmaßnahmen)

Monitor electrolytes and electrocardiograms in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. (Fachinformation zu Sorafenib, Warnhinweise und Vorsichtsmaßnahmen)

…electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances (e.g., hypokalemia, hypocalcemia, or hypomagnesemia). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Drugs that Prolong QT Interval SUTENT is associated with QTc interval prolongation [see Warnings and Precautions (5.3) , Clinical Pharmacology (12.2) ] . (Fachinformation zu Sunitinib, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Prophylaxis of PJP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required. (Fachinformation zu Temsirolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Cyclosporine, Tacrolimus: There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. (Fachinformation zu Tinidazol, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

The risk for nephrotoxicity may increase when ASTAGRAF XL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. (Fachinformation zu Triptorelin, Warnhinweise und Vorsichtsmaßnahmen)

…like other beta 2 -agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. (Fachinformation zu Umeclidiniumbromid und Vilanterol, Arzneimittelwechselwirkungen)

Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine) Unknown Because of potential for higher toxicity, coadministration with valganciclovir hydrochloride should be considered only if the… (Fachinformation zu Valganciclovir, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

• Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. (Fachinformation zu Tacrolimus, Warnhinweise und Vorsichtsmaßnahmen)

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and… (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Reduce ASTAGRAF XL dose (for voriconazole and posaconazole, give one-third of the original dose) and adjust dose based on tacrolimus whole blood trough concentrations [see Dosage and Administration ( 2.3 , 2.4 ) and Clinical Pharmacology ( 12.3 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

Strong CYP3A Inducers c : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.10 )]. (Fachinformation zu Tacrolimus, Arzneimittelwechselwirkungen)

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persists despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. (Fachinformation zu Atorvastatin, Warnhinweise und Vorsichtsmaßnahmen)

Thirty-four patients were treated with corticosteroids and one patient was treated with a non-steroidal immunosuppressant. (Fachinformation zu Axitinib, Warnhinweise und Vorsichtsmaßnahmen)

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy without significant inflammation; and improvement with immunosuppressive agents. (Fachinformation zu Ezetimib und Simvastatin, Warnhinweise und Vorsichtsmaßnahmen)

IMNM is characterized by proximal muscle weakness and elevated serum CK, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody, muscle biopsy showing necrotizing myopathy, and improvement with immunosuppressive agents. (Fachinformation zu Fluvastatin, Warnhinweise und Vorsichtsmaßnahmen)

IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. (Fachinformation zu Lovastatin, Warnhinweise)

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. (Fachinformation zu Pitavastatin, Warnhinweise und Vorsichtsmaßnahmen)

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. (Fachinformation zu Pravastatin, Warnhinweise und Vorsichtsmaßnahmen)

In some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis. (Fachinformation zu Propylthiouracil, Warnhinweise)

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. (Fachinformation zu Rosuvastatin, Warnhinweise und Vorsichtsmaßnahmen)

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy without significant inflammation; and improvement with immunosuppressive agents. (Fachinformation zu Simvastatin, Warnhinweise und Vorsichtsmaßnahmen)

In some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis. (Fachinformation zu Thiamazol, Warnhinweise)