Classes
DEA Class; Rx
Common Brand Names; Odefsey
- 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 patients (weighing at least 35 kg) with baseline HIV RNA of 100,000 copies/mL or less, and certain virologically-stable (HIV RNA less than 50 copies/mL) patients without history of treatment failure or resistance
Administered as a single tablet once daily with a meal
Indications
Indicated as a complete regimen for treatment of HIV-1 infection in treatment-naïve adults with HIV-1 RNA ≤100,000 copies/mL, and in certain virologically suppressed (HIV-1 RNA <50 copies/mL) patients on a stable antiretroviral therapy (ART) regimen at start of therapy in order to replace their current ART regimen
Contraindications
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
- Headache (rilpivirine) (19%)
- Depression (rilpivirine) (19%)
- Somnolence (rilpivirine) (14%)
- Nausea (rilpivirine) (11%)
- Nausea (10%)
- Mild/moderate depression (rilpivirine) (9%)
- Dizziness (rilpivirine) (8%)
- Abdominal pain (rilpivirine) (8%)
- Vomiting (rilpivirine) (6%)
- Rash (rilpivirine) (6%)
- Headache (2%)
- Sleep disturbances (2%)
- Severe depression (rilpivirine) (1%)
- Flatulence (1%)
- Abnormal dreams (1%)
- Diarrhea (1%)
Warnings
Severe acute exacerbation of hepatitis B in patients coinfection with HIV-1 and HBV
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
Severe depressive disorders reported; immediate medical evaluation recommended
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
Fat redistribution and accumulation observed with ART therapy
Immune reconstitution syndrome reported, including the occurrence of autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barre syndrome) with variable time to onset
Decreases in bone mineral density (BMD) and cases of osteomalacia associated with proximal renal tubulopathy reported with tenofovir; consider monitoring BMD with a history of pathologic fracture or if risk factors for bone loss exist
Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome reported with tenofovir AF-containing products reported
Lactic acidosis/severe hepatomegaly with steatosis may occur
Pregnancy and Lactation
Pregnancy exposure registry monitors pregnancy outcomes in individuals exposed to treatment during pregnancy
The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants, to avoid risking postnatal transmission of HIV
Based on published data, FTC has shown to be present in human breast milk
Maximum Dosage
1 tablet/day PO (200 mg emtricitabine; 25 mg rilpivirine; 25 mg tenofovir alafenamide).
1 tablet/day PO (200 mg emtricitabine; 25 mg rilpivirine; 25 mg tenofovir alafenamide).
weighing 35 kg or more: 1 tablet/day PO (200 mg emtricitabine; 25 mg rilpivirine; 25 mg tenofovir alafenamide).
weighing less than 35 kg: Safety and efficacy have not been established.
12 years and weighing 35 kg or more: 1 tablet/day PO (200 mg emtricitabine; 25 mg rilpivirine; 25 mg tenofovir alafenamide).
1 to 11 years or 12 years 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 AF (tenofovir alafenamide)
tablet
- 200mg/25mg/25mg
