COMPLERA Rx

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COMPLERA

Viral infections
Only 4 drugs may be compared at once

Generic Name and Formulations:

Emtricitabine 200mg, tenofovir disoproxil fumarate 300mg, rilpivirine 25mg; tabs.

Select 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, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than single dose), St. John's wort.

Warnings/Precautions:

Risk of lactic acidosis or severe hepatomegaly with steatosis; suspend if 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). Assess CrCl prior to initiating therapy in all patients. Monitor CrCl, serum phosphorus, urine glucose and protein prior to initiation and periodically during therapy in patients at risk for renal impairment. Discontinue immediately if severe skin or hypersensitivity reactions develop. Severe hepatic impairment. 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, lamivudine, or adefovir dipivoxil. Avoid concomitant or recent use of nephrotoxic agents. Tenofovir levels increased by concomitant ledipasvir/sofosbuvir; monitor for toxicity. 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). Rilpivirine levels decreased by concomitant rifabutin (see Adults). 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:

Depressive disorders, insomnia, headache, diarrhea, nausea, fatigue, dizziness, depression, abnormal dreams, rash; fat redistribution, immune reconstitution syndrome, lactic acidosis, severe hepatomegaly with steatosis, hepatotoxicity.

Generic Availability:

NO

How Supplied:

Tabs—30

COMPLERA 200mg/25mg/300mg tablets (Qty:30)

appx. price $2538.00