Lopinavir and ritonavir and Oliceridine interaction

If a CYP3A4 inducer is discontinued, consider OLINVYK dosage reduction and monitor for signs of respiratory depression.

Risk of Use in Patients with Decreased Cytochrome P450 2D6 Function or Concomitant Use or Discontinuation with Cytochrome P450 3A4 Inhibitors and Inducers Risk of Increased Oliceridine Plasma Concentrations Increased plasma concentrations of oliceridine, which may result in prolonged opioid adverse reactions and exacerbated respiratory depression, may occur when…

In patients taking a moderate or strong CYP3A4 inhibitor In patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor Discontinuation of a CYP3A4 inducer These patients may require less frequent dosing of OLINVYK.

…oliceridine, which may lead to decreased efficacy, may occur under the following conditions: Concomitant use of OLINVYK with CYP3A4 inducers Discontinuation of a moderate or strong CYP3A4 or CYP2D6 inhibitor Closely monitor these patients at frequent intervals and consider supplemental doses of OLINVYK [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7 )] .

Table 6: Clinically Significant Drug Interactions with OLINVYK Moderate to Strong Inhibitors of CYP2D6 Clinical Impact: Concomitant administration of a moderate to strong CYP2D6 inhibitor can increase the plasma concentration of oliceridine [see Clinical Pharmacology ( 12.3 )] , resulting in increased or prolonged opioid effects.

…Hepatitis C direct acting antiviral: elbasvir/grazoprevir HMG-CoA Reductase Inhibitors: lovastatin, simvastatin Microsomal triglyceride transfer protein (MTTP) Inhibitor: lomitapide Non-opioid Analgesic (selective blocker of Nav1.8 sodium channels): suzetrigine PDE5 Inhibitor: sildenafil (Revatio ® ) when used for the treatment of pulmonary arterial hypertension Sedative/Hypnotics:…

Postmarketing life-threatening cases of cardiac toxicity (including complete AV block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, CNS depression and respiratory complications leading to death have been reported, predominantly in preterm neonates receiving KALETRA oral solution.

Sedative/Hypnotics: triazolam, orally administered midazolam ↑ triazolam ↑ midazolam Contraindicated due to potential for prolonged or increased sedation or respiratory depression [see Contraindications ( 4 )] .

…potential risks, infants should be monitored closely for increases in serum osmolality and serum creatinine, and for toxicity related to KALETRA oral solution including: hyperosmolality, with or without lactic acidosis, renal toxicity, CNS depression (including stupor, coma, and apnea), seizures, hypotonia, cardiac arrhythmias and ECG changes, and hemolysis.

Analgesics Opioid: methadone* fentanyl Non-opioid analgesic (selective blocker of Na v 1.8 sodium channels): suzetrigine ↓ methadone ↑ fentanyl ↑ suzetrigine and active metabolite M6-SUZ Dosage of methadone may need to be increased when co-administered with KALETRA.