KIDNEY AND BONEHEALTH

Kidneys play a key role in keeping you healthy, working around the clock to remove waste from your blood. That’s why it’s so important to take care of them, especially if you have HIV-1. Ask your healthcare provider how HIV-1 medicines can impact your kidneys.

Less impact on kidney lab tests:

In clinical studies, an HIV-1 treatment containing two of the medicines* in ODEFSEY® had less impact on kidney lab test results than the other approved HIV-1 treatments.

It is not known if these lab test results predict long-term kidney health.

In clinical studies, less than 1% of adults who took an HIV-1 treatment containing two of the medicines* in ODEFSEY had to stop due to kidney-related issues.

ODEFSEY may also cause new or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking ODEFSEY. Your healthcare provider may tell you to stop taking ODEFSEY if you develop new or worse kidney problems.

*The two medicines were emtricitabine and tenofovir alafenamide, which were taken with elvitegravir and cobicistat to form a complete treatment.

The other treatments in these studies were STRIBILD® (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate), ATRIPLA® (efavirenz, emtricitabine, and tenofovir disoproxil fumarate), or TRUVADA® (emtricitabine and tenofovir disoproxil fumarate) + Reyataz (atazanavir) + cobicistat or ritonavir.

Please see Important Facts about ODEFSEY, including important warnings.

ODEFSEY is FDA-approved for people with mild-to-moderate kidney problems and can be used in some people with lowered kidney function without changing the dose.

Because HIV-1 medicines may impact your bones, it’s important to protect your bone health. If you’re under 30 years of age, you’re still developing bone mass. If you’re over 30, your bones have fully developed and it’s important to try to maintain them.

Less impact on bone mineral density:

In clinical studies, an HIV-1 treatment containing two of the medicines* in ODEFSEY® had less impact on hip and lower spine bone mineral density than the other approved HIV-1 treatments.

The long-term effect of these changes on bone health is not known.

ODEFSEY may also cause serious side effects, including bone problems, such as bone pain, softening, or thinning, which may lead to fractures. Your healthcare provider may need to do tests to check your bones.

*The two medicines were emtricitabine and tenofovir alafenamide, which were taken with elvitegravir and cobicistat to form a complete treatment.

The other treatments in these studies were STRIBILD® (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate), ATRIPLA® (efavirenz, emtricitabine, and tenofovir disoproxil fumarate), or TRUVADA® (emtricitabine and tenofovir disoproxil fumarate) + Reyataz (atazanavir) + cobicistat or ritonavir.


Ask your healthcare provider how to be proactive about your bone health.

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.