Elvitegravir, kobisistat, emtrisitabin ve tenofovir ve Oliseridin etkileşimi

…Lipid-modifying Agents: lomitapide, lovastatin, simvastatin Phosphodiesterase-5 (PDE-5) Inhibitor: sildenafil when administered as REVATIO ® for the treatment of pulmonary arterial hypertension Sedative/hypnotics: triazolam, orally administered midazolam Coadministration of GENVOYA is contraindicated with drugs that: Are highly dependent on CYP3A for clearance and for which…

Sedative/hypnotic: midazolam (oral) triazolam ↑ midazolam ↑ triazolam Coadministration with triazolam or orally administered midazolam is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.

Dosage reduction for midazolam should be considered, especially if more than a single dose of midazolam is administered. buspirone zolpidem With other sedative/hypnotics, dose reduction may be necessary and clinical monitoring is recommended.

Other benzodiazepines: e.g., parenterally administered midazolam clorazepate diazepam estazolam flurazepam ↑ sedatives/hypnotics Triazolam and orally administered midazolam are extensively metabolized by CYP3A.

Narcotic Analgesics: buprenorphine/ naloxone ↑ buprenorphine ↑ norbuprenorphine ↓ naloxone No dosage adjustment of buprenorphine/naloxone is required upon coadministration with GENVOYA.

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.

If a CYP2D6 inhibitor is discontinued, increase of the OLINVYK dosage may be considered until stable drug effects are achieved.