What are the most important things to know about Odefsey?
Odefsey can cause serious, life-threatening side effects. These include a buildup ofin the blood ( ), problems, severe skin rash and allergic reactions, or mood changes, and new or worsening kidney problems, including kidney failure.
Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
- Weakness or tiredness
- Unusual muscle pain
- Shortness of breath or fast breathing
- Stomach pain with nausea and vomiting
- Cold or blue hands and feet
- Dizziness or lightheadedness
- Fast or abnormal heartbeat
Some people taking Odefsey may develop liver problems. People with a history of(HBV) or (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Odefsey. Liver problems may also occur in people taking Odefsey who have no history of liver disease.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea or vomiting
- Pain, aching, or tenderness on the right side of your stomach/abdominal area
If you have both HIV and HBVand take Odefsey, your HBV infection may get much worse (flare up) if you stop taking Odefsey. Do not stop taking Odefsey without first talking with your health care provider.
Contact your health care provider right aware if you develop a rash while taking Odefsey. Stop taking Odefsey and get medical help right away if you develop a rash with any of the following symptoms:
- General ill feeling
- Extreme tiredness
- Muscle or joint aches
- Blistering or peeling skin
- Blisters or sores in your mouth
- Redness or swelling of the eyes ( )
- Swelling of your face, lips, mouth, tongue, or throat
- Trouble breathing or swallowing
Contact your health care provider right away if you have any of the following symptoms that could be signs of depression or mood changes:
- Feeling sad or hopeless
- Feeling anxious or restless
- Harming yourself or having thoughts about harming yourself (including suicidal thoughts)
Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called), which may be related to tenofovir-containing drugs:
- Bone pain that does not go away or gets worse
- Pain in your arms, hands, legs, or feet
- Broken bones
- Muscle pain or weakness
While taking Odefsey, it is important to keep all your appointments with your health care provider.
What is Odefsey?
Odefsey is a prescription medicine approved by the U.S.(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 HIVand should not be used with other HIV medicines.
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 Living 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. 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?
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.
- 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 breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
- If you are using HIV and Birth Control infographic. -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
- 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?
Odefsey comes in tablet form. Each tablet contains:
Take Odefsey according to your health care provider’s instructions. Do not miss aof 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. 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) 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?
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?
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 (called 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 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?
- 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?
- 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 Living 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 Counseling Information section of the label includes information for people taking Odefsey.
- Odefsey-related research studies, from .
- A list of FDA-approved HIV medicines, from HIVinfo.
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
Last Reviewed: January 3, 2022