What is ODEFSEY? ODEFSEY is a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older: • who have not received anti-HIV-1 medicines in the past and who have an amount of HIV-1 in their blood (this is called “viral load”) that is no more than 100,000 copies/mL, or • to replace their current anti-HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). ODEFSEY does not cure HIV-1 or AIDS. ODEFSEY contains the prescription medicines emtricitabine, rilpivirine and tenofovir alafenamide. It is not known if ODEFSEY is safe and effective in children under 12 years of age or who weigh less than 77 lb (35 kg).
How should I take ODEFSEY? • Take ODEFSEY exactly as your healthcare provider tells you to take it. ODEFSEY is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection. • Take ODEFSEY 1 time each day with a meal. • Do not change your dose or stop taking ODEFSEY without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment with ODEFSEY. • Do not miss a dose of ODEFSEY. • When your ODEFSEY supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ODEFSEY and become harder to treat. • If you take too much ODEFSEY, call your healthcare provider or go to the nearest hospital emergency room right away.
ODEFSEY can cause serious side effects, including: Worsening of Hepatitis B virus infection. If you have hepatitis B virus (HBV) infection and take ODEFSEY, your HBV may get worse (flare-up) if you stop taking ODEFSEY. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. • Do not run out of ODEFSEY. Refill your prescription or talk to your healthcare provider before your ODEFSEY is all gone. • Do not stop taking ODEFSEY without first talking to your healthcare provider. • If you stop taking ODEFSEY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking ODEFSEY. For more information about side effects, see “What are the possible side effects of ODEFSEY?”