Drug Database: Emtricitabine / Rilpivirine / Tenofovir Alafenamide

What is Odefsey?What is Odefsey?

What is Odefsey?

Odefsey is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 12 years of age and older who weigh at least 77 lb (35 kg) and who meet certain requirements, as determined by a health care provider.

Odefsey is a complete HIV treatment regimen and should not be used with other HIV medicines.

Odefsey contains three different medicines: emtricitabine, rilpivirine, and tenofovir alafenamide.

For more information on the use of Odefsey in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. 

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking Odefsey?What should I tell my health care provider before taking Odefsey?

What should I tell my health care provider before taking Odefsey?

Before taking Odefsey, tell your health care provider:

• If you are allergic to any of the HIV medicines in Odefsey (emtricitabine, rilpivirine, or tenofovir alafenamide) or any other medicines.
• If you have liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have kidney problems, including if you are on dialysis.
• If you have ever had mental health problems.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Odefsey during pregnancy. For more information on the use of Odefsey during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. 
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Odefsey may affect the way other medicines or products work, and other medicines or products may affect how Odefsey works. Taking Odefsey together with certain medicines or products may cause serious side effects.

How should I take Odefsey?How should I take Odefsey?

How should I take Odefsey?

Odefsey comes in tablet form. Each tablet contains:

• 200 mg emtricitabine
• 25 mg rilpivirine
• 25 mg tenofovir alafenamide

Take Odefsey according to your health care provider’s instructions. Do not miss a dose of Odefsey, and do not change your dose or stop taking Odefsey without first talking with your health care provider.

Take Odefsey one time each day with a meal. If you are taking any other medicines or supplements, including antacids or H2 blockers (medicines for reducing stomach acid), or other products containing aluminum, calcium carbonate, or magnesium hydroxide, carefully follow instructions on how to take them with Odefsey.

Proton pump inhibitors (medicines for reducing stomach acid) should NOT be taken with Odefsey.

If you are receiving dialysis, take your daily dose of Odefsey after dialysis.

Do not take Odefsey with other HIV medicines.

If you have taken too much Odefsey, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.

For more information on how to take Odefsey, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Odefsey, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Odefsey cause?What side effects can Odefsey cause?

What side effects can Odefsey cause?

Odefsey may cause side effects. Some side effects of Odefsey can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of Odefsey include:

• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Headache and problems sleeping.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Odefsey. To learn more about possible side effects of Odefsey, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Odefsey be stored?How should Odefsey be stored?

How should Odefsey be stored?

• Store Odefsey below 86°F (30°C).
• Keep Odefsey in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
• Do not use Odefsey if the original seal over the container opening is broken or missing.
• Throw away Odefsey that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Odefsey and all medicines out of reach of children.

Where can I find more information about Odefsey?Where can I find more information about Odefsey?

Where can I find more information about Odefsey?

• For more information on the use of Odefsey in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. 
• This Patient Version drug summary is based on the following FDA label(s): Tablet. The Patient Package Insert includes information for people taking Odefsey.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for emtricitabine, rilpivirine, and tenofovir available from MedlinePlus.
• Odefsey-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.