Emtricitabine, Rilpivirine and Tenofovir disoproxil

COMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA.

COMPLERA is a fixed-dose combination of the antiretroviral drugs FTC, RPV, and TDF.

Testing: Prior to or when initiating COMPLERA, test for hepatitis B virus infection. Prior to initiation and during treatment with COMPLERA, 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 in adults and pediatric patients weighing at least 35 kg: One tablet taken orally once daily with food. For pregnant patients who are already on COMPLERA 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. Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute.

COMPLERA is contraindicated when coadministered with the following drugs, coadministration may result in loss of virologic response and possible resistance to COMPLERA 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 COMPLERA is contraindicated when coadministered with drugs which may result in loss of virologic response and possible resistance to COMPLERA.

Boxed warning (posttreatment acute exacerbation of hepatitis b): Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of COMPLERA. Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during postmarketing experience, 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 a rilpivirine-containing regimen.

The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV. Skin and Hypersensitivity Reactions. Hepatotoxicity. Depressive Disorders. New Onset or Worsening Renal Impairment. Bone Loss and Mineralization Defects. Lactic Acidosis/Severe Hepatomegaly with Steatosis. Immune Reconstitution Syndrome. Most common adverse reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2–4) are depressive disorders, insomnia, and headache. Most common adverse reactions to emtricitabine and tenofovir disoproxil fumarate (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

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

Store at 25 °C (77 °F), excursions permitted to 15 °C–30 °C (59 °F–86 °F).