How to Take ODEFSEY

Take ODEFSEY® exactly as your healthcare provider tells you to take it. Do not miss a dose.

Do not change your dose or stop taking ODEFSEY without first talking with your healthcare provider. Stay under a healthcare provider's care when taking ODEFSEY.

Understand how to take your HIV-1 treatment and tell your healthcare provider about all the medicines you are taking, including over-the-counter medicines, vitamins, and herbal supplements.

Understand how to take your HIV-1 treatment and tell your healthcare provider about all the medicines you are taking, including over-the-counter medicines, vitamins, and herbal supplements.

ODEFSEY is a complete treatment for HIV-1. Do not take it with any other HIV-1 medicines.

ODEFSEY can affect the way other medicines work and other medicines can affect how ODEFSEY works, which may cause serious side effects. Some medicines may also make the amount of ODEFSEY in your body too low to help keep your HIV-1 undetectable, and the virus may become resistant to ODEFSEY.

Who should not take ODEFSEY?

Do not take ODEFSEY if you also take a medicine that contains:

GENERIC NAME BRAND NAME
Carbamazepine Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®
Dexamethasone Ozurdex®, Maxidex®, Decadron®, Baycadron
Dexlansoprazole Dexilant®
Esomeprazole Nexium®, Vimovo®
Lansoprazole Prevacid®
Omeprazole Prilosec®, Zegerid®
Oxcarbazepine Trileptal®
Pantoprazole sodium Protonix®
Phenobarbital Luminal®
Phenytoin Dilantin®, Dilantin-125®, Phenytek®
Rabeprazole Aciphex®
Rifampin Rifadin®, Rifamate®, Rifater®, Rimactane®
Rifapentine Priftin®
St. John's wort St. John's wort

ODEFSEY is a complete treatment for HIV-1. Do not take it with any other HIV-1 medicines.

What should I do if I take too much?

  • If you take too much ODEFSEY, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I do if I run out of medicine?

  • 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 even for a short time. The virus may develop resistance to ODEFSEY and become harder to treat.

What if I need to take medicines for heartburn or other stomach problems?

  • Ask your healthcare provider if it is safe to take ODEFSEY with your stomach medicine, as some stomach medicines should not be taken with ODEFSEY.

What should I tell my healthcare provider before taking ODEFSEY?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, bone, mental health (depression or suicidal thoughts), or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how ODEFSEY works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take ODEFSEY with all of your other medicines.

What if I am pregnant or breastfeeding, or planning to become pregnant or breastfeed?

  • Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if ODEFSEY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking ODEFSEY.
  • Tell your healthcare provider if you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

Understand how to take your HIV-1 treatment and tell your healthcare provider about all the medicines you are taking, including over-the-counter medicines, vitamins, and herbal supplements.

Understand how to take your HIV-1 treatment and tell your healthcare provider about all the medicines you are taking, including over-the-counter medicines, vitamins, and herbal supplements.

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.