Viral infections:

Indications for: COMPLERA

As a complete regimen for HIV-1 infection in patients who are antiretroviral treatment-naïve with HIV-1 RNA ≤100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Complera.

Adults and Children:

<12yrs (<35kg): not established. Test for HBV infection prior to and at initiation. ≥12yrs (≥35kg): 1 tab once daily with food. Pregnancy (already on prior stable dose and with HIV-1 RNA <50 copies/mL): continue with 1 tab once daily; monitor viral load. Renal impairment (CrCl<50mL/min): not recommended. If concomitant with rifabutin regimen: take additional rilpivirine 25mg once daily.

COMPLERA Contraindications:

Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than a single dose), St. John's wort.

Boxed Warning:

Post-treatment acute exacerbation of Hepatitis B.

COMPLERA Warnings/Precautions:

Discontinuation of emtricitabine and/or tenofovir disoproxil may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Underlying hepatitis B or C, or marked elevations in liver-associated tests; monitor for hepatotoxicity. Consider monitoring LFTs in those without pre-existing hepatic dysfunction or other risks. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) prior to or when initiating, and during therapy. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Promptly evaluate if severe depressive symptoms occur. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Discontinue immediately if severe skin or hypersensitivity reactions develop. Severe hepatic impairment. Pregnancy. Nursing mothers: not recommended.

COMPLERA Classification:

Nucleoside analogue reverse transcriptase inhibitors + non-nucleoside reverse transcriptase inhibitor.

COMPLERA Interactions:

See Contraindications. Concomitant other antiretroviral agents: not recommended. Rilpivirine: potentiated by CYP3A inhibitors; antagonized by CYP3A inducers, concomitant rifabutin (see Adults). Emtricitabine/tenofovir: may be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Tenofovir levels increased by concomitant ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir; monitor for toxicity. Concomitant drugs with a known risk for Torsade de Pointes; consider alternatives. Separate antacids by ≥2hrs before or 4hrs after rilpivirine; or H2-receptor antagonists by ≥12hrs before or ≥4hrs after rilpivirine; drugs that increase gastric pH may decrease rilpivirine plasma levels. Monitor for breakthrough fungal infections with concomitant azole antifungals. Concomitant clarithromycin, erythromycin, telithromycin; consider alternative (eg, azithromycin). Monitor methadone.

Adverse Reactions:

Depressive disorders, insomnia, headache, diarrhea, nausea, fatigue, dizziness, abnormal dreams, rash; decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome.

Generic Drug Availability:


How Supplied: