ODEFSEY is an oral combination formulation of the HIV Nucleoside analog Reverse Transcriptase Inhibitor (NRTI) drugs emtricitabine (200mg) and tenofovir alafenamide fumarate (25mg), and the second-generation Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) rilpivirine (25mg). ODEFSEY is used as a complete regimen for treatment of HIV-1 infection in certain patients, and should not be administered with other antiretroviral medications.
Dosing & Administration
ODEFSEY is indicated for the treatment of HIV infection in adults and children weighing 35 kg or more who meet specific criteria related to their treatment history, HIV RNA concentration, and evidence of virologic failure. Specifics are given in the product monograph. ODEFSEY is dosed as one tablet per day, taken with food. ODEFSEY comes in a film-coated tablet.
COMPLERA can be used without dosage adjustment in patients with a creatinine clearance >=30 mL/min, but is not recommended for use in patients with renal function below that level. Dosage adjustments are not needed for mild or moderate hepatic impairment, but safety and efficacy have not been established for use in severe hepatic impairment.
ODEFSEY is contraindicated in patients with hypersensitivity to any of its components, and in patients who are taking certain other medications listed in the product monograph.
ODEFSEY is associated with viral resistance, immune reconstitution syndrome, osteonecrosis, headache, insomnia, diarrhea, dizziness, nausea, fatigue, rash, and abnormal dreams. A more complete list of potential adverse effects is provided in the product monograph.
ODEFSEY is not indicated for the treatment of hepatitis infections. Patients who are co-infected with HIV and Hepatitis B virus (HBV) or Hepatitis C virus (HCV) may be at higher risk of treatment-related hepatotoxicity. Severe acute exacerbations of HBV disease may occur when discontinuing ODEFSEY. All patients who test positive for HIV infection should be screened for comorbid HBV and HCV infection. Co-infected patients should be started on an antiretroviral regimen targeting co-infected viruses, regardless of CD4 counts or viral loads. Current HIV treatment guidelines outline drug regimens and prescribing considerations.
ODEFSEY has been associated with severe skin and hypersensitivity reactions, as well as hepatotoxicity, lactic acidosis and hepatomegaly with steatosis, new or worsening renal impairment, Fanconi syndrome, bone mineral density (BMD) loss, depressive disorders, suicidal ideation/behavior, and QTc prolongation. All of these can be serious or life threatening. Screening and monitoring guidelines are detailed in the product monograph.
ODEFSEY is associated with a large number of drug-drug and herbal interactions, cautions, and contraindications. These are listed in the product monograph.
Pregnancy & Lactation
Highly active retroviral combination treatment should be used in all pregnant women. There is insufficient data to characterize the safety of ODEFSEY use in pregnancy. Current guidelines should be consulted when treating pregnant women. Components of ODEFSEY are excreted in breast milk. The CDC recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
ODEFSEY overdose should be treated with standard supportive care and monitoring. Some components of ODEFSEY are partially dialyzable.
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