Indications for COMPLERA:
HIV-1 infection.
Adult Dose for COMPLERA:
Take with a meal. 1 tablet once daily. Renal impairment (CrCl<50mL/min): not recommended.
Children's Dose for COMPLERA:
<18yrs: not recommended.
Pharmacological Class:
Nucleoside analogue reverse transcriptase inhibitors + non-nucleoside reverse transcriptase inhibitor.
Contraindications:
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than single dose), St. John's wort.
Warnings/Precautions:
Suspend if lactic acidosis or hepatotoxicity occurs. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Not for treating chronic hepatitis B; test for HBV before starting therapy and monitor patients coinfected with HIV-1 and HBV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Renal impairment: monitor CrCl and serum phosphorus. May prolong QTc interval with supratherapeutic doses. History or risk of fractures or osteopenia: monitor bone mineral density (BMD); consider Vitamin D and calcium supplementation. Pregnancy (Cat. B). Nursing mothers: not recommended.
Interactions:
Avoid concomitant drugs that contain emtricitabine, tenofovir, rilpivirine, lamivudine, or adefovir dipivoxil. Emtricitabine/tenofovir: Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). Avoid concomitant or recent use of nephrotoxic agents. Rilpivirine: Potentiated by CYP3A inhibitors. Antagonized by CYP3A inducers (see Contraindications). May antagonize azole antifungals (monitor for breakthrough fungal infections), methadone (monitor). Separate antacids (by at least 2 hours before or at least 4 hours after) and H2-receptor antagonists (by at least 12 hours before or 4 hours after) rilpivirine; drugs that increase gastric pH may result in decreased plasma concentrations. Caution with drugs with a known risk for torsades de pointes.
Adverse Reactions:
Insomnia, headache, diarrhea, nausea, fatigue, dizziness, depression, abnormal dreams, rash; fat redistribution, immune reconstitution syndrome, lactic acidosis, severe hepatomegaly with steatosis (may be fatal), hepatotoxicity (monitor).
How Supplied:
Tabs—30
