Classes
DEA Class; Rx
Common Brand Names; Complera
- HIV, ART Combos
Description
Combination of 2 NRTIs and 1 NNRTI
Indicated as a complete regimen for treatment of HIV-1 infections in antiretroviral-naive adults and pediatric patients (weighing at least 35 kg) with baseline HIV-1 RNA of 100,000 copies/mL or less and certain virologically-stable (HIV-1 RNA less than 50 copies/mL) patients without history of treatment failure or resistance
Administered as a single tablet once daily with meals
Indications
Indicated as a complete regimen for treatment of HIV-1 infection in treatment-naïve adults with HIV-1 RNA ≤100,000 copies/mL at start of therapy and in certain virologically suppressed (HIV-1 RNA <50 copies/mL) patients on a stable antiretroviral therapy (ART)
Contraindications
Hypersensitivity
Coadministration of the following drugs
- Anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
- Antimycobacterials (eg, rifabutin, rifampin, rifapentine)
- Glucocorticoid systemic dexamethasone (more than a single dose)
- St. John’s wort
- Proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
Adverse Effects
rilpivirine
- Increased ALT (Grade 1: 16%)
- Increased AST (Grade 1: 13%)
- Increased total cholesterol (Grade 1: 13%)
- Increased LDL cholesterol (Grade 1: 11%)
emtricitabine and tenofovir
- Diarrhea
- Nausea
- Fatigue
- Headache
- Dizziness
- Depression
- Insomnia
- Abnormal dreams
- Rash
Warnings
Lactic acidosis/severe hepatomegaly with steatosis
Coinfection with HIV-1 and HBV (see Black Box Warnings)
Severe skin and hypersensitivity reactions reported, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS) with rilpivirine (RPV)-containing regimens; discontinue therapy immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, including but not limited to, severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis, or eosinophilia; monitor and initiate appropriate therapy
Hepatic adverse events reported in patients receiving an RPV-containing regimen; a few cases of hepatic toxicity reported in adults who had no preexisting hepatic disease or other identifiable risk factors
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), with tenofovir DF (TDF)
Redistribution/accumulation of body fat observed in patients receiving antiretroviral therapy
May increase risk for immune reconstitution syndrome; autoimmune disorders (such as Graves’ disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) reported; however, the time to onset is more variable and can occur many months after initiation of treatment
Severe depressive disorders reported; immediate medical evaluation recommended
Pregnancy and Lactation
Pregnancy exposure registry monitors pregnancy outcomes in individuals exposed to treatment during pregnancy
The Centers for Disease Control and Prevention recommends HIV infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV
Based on published data, FTC and tenofovir reported to be present in human milk
Maximum Dosage
1 tablet/day PO (each tablet containing emtricitabine 200 mg; rilpivirine 25 mg; tenofovir DF 300 mg).
1 tablet/day PO (each tablet containing emtricitabine 200 mg; rilpivirine 25 mg; tenofovir DF 300 mg).
weighing 35 kg or more: 1 tablet/day PO (each tablet containing emtricitabine 200 mg; rilpivirine 25 mg; tenofovir DF 300 mg).
weighing less than 35 kg: Safety and efficacy have not been established.
weighing 35 kg or more: 1 tablet/day PO (each tablet containing emtricitabine 200 mg; rilpivirine 25 mg; tenofovir DF 300 mg).
weighing less than 35 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Emtricitabine/rilpivirine/tenofovir DF (ie, tenofovir disoproxil fumarate)
tablet
- 200mg/25mg/300mg
