Generic Name and Formulations:
Emtricitabine 200mg, tenofovir disoproxil fumarate 300mg, rilpivirine 25mg; tabs.

Company:
Gilead Sciences, Inc.
Indications for COMPLERA:
As a complete regimen to treat HIV-1 infection in antiretroviral treatment-naive adults with HIV-1 RNA ≤100,000 copies/mL at the start of therapy and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adults on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen. See full labeling.

Adult:
Take with a meal. 1 tab once daily. After replacement: do additional monitoring of HIV-1 RNA to assess for potential virologic failure or rebound. Renal impairment (CrCl<50mL/min): not recommended. If concomitant rifabutin needed: take additional rilpivirine 25mg once daily.

Children:
<18yrs: not recommended.

Contraindications:
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, 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 (eg, hepatomegaly, steatosis) occurs. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity (monitor). 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, serum phosphorus, urine glucose and protein before and periodically during therapy. Increased risk of hepatotoxicity; monitor LFTs before and during therapy for all patients. May prolong QTc interval with supratherapeutic doses. History of bone fractures or other risks for osteoporosis or bone loss: monitor bone mineral density (BMD); consider Vit.D and calcium supplementation. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
Avoid concomitant drugs that contain emtricitabine, tenofovir, rilpivirine, lamivudine, or adefovir dipivoxil. Avoid concomitant or recent use of nephrotoxic agents. Avoid concomitant rilpivirine unless needed for dose adjustment with rifabutin (see Adults). Emtricitabine/tenofovir: monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Rilpivirine: potentiated by CYP3A inhibitors. Antagonized by CYP3A inducers (see Contraindications). May antagonize azole antifungals (monitor for breakthrough fungal infections), methadone (monitor). May be potentiated by clarithromycin, erythromycin, telithromycin. Separate dosing of antacids by at least 2hrs before or at least 4hrs after rilpivirine; or H2-receptor antagonists by at least 12hrs before or 4hrs after rilpivirine; drugs that increase gastric pH may result in decreased plasma concentrations. Caution with drugs with a known risk for torsades de pointes.

Pharmacological Class:
Nucleoside analogue reverse transcriptase inhibitors + non-nucleoside reverse transcriptase inhibitor.

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, severe skin or hypersensitivity reactions (discontinue if occurs).

How Supplied:
Tabs—30