Emtricitabine, Rilpivirine and Tenofovir alafenamide

ODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY.

ODEFSEY is a fixed dose combination of antiretroviral drugs emtricitabine, rilpivirine, and tenofovir alafenamide.

Testing: Prior to or when initiating ODEFSEY, test for hepatitis B virus infection. Prior to or when initiating ODEFSEY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Recommended dosage: one tablet taken orally once daily with a meal. For pregnant patients who are already on ODEFSEY prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

ODEFSEY is contraindicated when coadministered with the following drugs, coadministration may result in loss of virologic response and possible resistance to ODEFSEY or to the class of NNRTIs: Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered with drugs where significant decreases in RPV plasma concentrations may occur, which may result in loss of…

Boxed warning (post treatment acute exacerbation of hepatitis b): Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY. Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during postmarketing experience with RPV-containing regimens, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Immediately discontinue treatment if hypersensitivity or rash with systemic symptoms or elevations in hepatic serum biochemistries develops and closely monitor clinical status, including hepatic serum biochemistries. Hepatotoxicity: Hepatic adverse events have been reported in patients receiving an RPV-containing regimen.

The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B Skin and Hypersensitivity Reactions Hepatotoxicity Depressive Disorders New Onset or Worsening Renal Impairment Lactic Acidosis/Severe Hepatomegaly with Steatosis Immune Reconstitution Syndrome Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache and sleep disturbances.

ODEFSEY is a complete regimen for the treatment of HIV-1 infection, therefore, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Consult the Full Prescribing Information prior to and during treatment for important drug interactions.

Store below 30°C (86°F).