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Important Safety Information

What is the most important information I should know about ODEFSEY®?

ODEFSEY may cause serious side effects:

Who should not take ODEFSEY?

Do not take ODEFSEY if you take:

What are the other possible side effects of ODEFSEY?

Serious side effects of ODEFSEY may also include:

The most common side effects of rilpivirine, one of the medicines in ODEFSEY, are depression, trouble sleeping (insomnia), and headache.

The most common side effect of emtricitabine and tenofovir alafenamide, two of the medicines in ODEFSEY, is nausea.

Tell your healthcare provider if you have any side effects that bother you or do not go away.

What should I tell my healthcare provider before taking ODEFSEY?

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call .

What is ODEFSEY?

ODEFSEY is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older. It can either be used in people who are starting HIV-1 treatment, have never taken HIV-1 medicines before, and have an amount of HIV-1 in their blood ("viral load") that is no more than 100,000 copies/mL; or in people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. ODEFSEY combines 3 medicines into 1 pill taken once a day with a meal. ODEFSEY is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

ODEFSEY does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking ODEFSEY. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Please see Important Facts about ODEFSEY, including important warnings.