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COMPLERA
Viral infections
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Drug Name:

COMPLERA Rx

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

Company:
Gilead Sciences, Inc.

Therapeutic Use:

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. ≥12yrs (and ≥35kg): 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 with rifabutin regimen: take additional rilpivirine 25mg once daily.

Children:

<12yrs or <35kg: not established.

Contraindications:

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

Warnings/Precautions:

Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. 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. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl (in all patients), serum phosphorus, urine glucose and urine protein prior to initiation and periodically during therapy in patients at risk for renal impairment. Prolongation of QTc interval with higher doses. 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 (Cat.B). Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant drugs that contain emtricitabine, tenofovir DF, tenofovir alafenamide, rilpivirine (unless for dose adjustment), lamivudine, or adefovir dipivoxil. Avoid concomitant or recent use of nephrotoxic agents. Rilpivirine: potentiated by CYP3A inhibitors; antagonized by CYP3A inducers, concomitant 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). Tenofovir levels increased by concomitant ledipasvir/sofosbuvir or sofosbuvir/velpatasvir; monitor for toxicity. Caution with drugs with a known risk for Torsade de Pointes. 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 result in decreased plasma levels. Monitor for breakthrough fungal infections with concomitant azole antifungals. Concomitant clarithromycin, erythromycin, telithromycin; consider alternative (eg, azithromycin). Monitor methadone.

Pharmacological Class:

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

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 Availability:

NO

How Supplied:

Tabs—30

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