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Important Safety Information
What is the most important information I should know about ODEFSEY?
ODEFSEY may cause serious side effects:
- Buildup of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold (especially in your arms and legs), feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.
- Serious liver problems. The liver may become large and fatty. Symptoms of liver problems include your skin or the white part of your eyes turning yellow (jaundice); dark "tea-colored" urine; loss of appetite; light-colored bowel movements (stools); nausea; and/or pain, aching, or tenderness on the right side of your stomach area.
- You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking ODEFSEY or a similar medicine for a long time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
- Worsening of hepatitis B (HBV) infection. ODEFSEY is not approved to treat HBV. If you have both HIV-1 and HBV and stop taking ODEFSEY, your HBV may suddenly get worse. Do not stop taking ODEFSEY without first talking to your healthcare provider, as they will need to monitor your health.
Who should not take ODEFSEY?
Do not take ODEFSEY if you take:
- Certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with ODEFSEY. Do not start a new medicine without telling your healthcare provider.
- The herbal supplement St. John's wort.
- Any other medicines to treat HIV-1 infection.
What are the other possible side effects of ODEFSEY?
Serious side effects of ODEFSEY may also include:
- Severe skin rash and allergic reactions. Skin rash is a common side effect of ODEFSEY. Call your healthcare provider right away if you get a rash, as some rashes and allergic reactions may need to be treated in a hospital. Stop taking ODEFSEY and get medical help right away if you get a rash with any of the following symptoms: fever, skin blisters, mouth sores, redness or swelling of the eyes (conjunctivitis), swelling of the face, lips, mouth, or throat, trouble breathing or swallowing, pain on the right side of the stomach (abdominal) area, and/or dark "tea-colored" urine.
- Depression or mood changes. Tell your healthcare provider right away if you: feel sad or hopeless, feel anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself.
- Changes in liver enzymes. People who have had hepatitis B or C or who have certain liver enzyme changes may have a higher risk for new or worse liver problems while taking ODEFSEY. Liver problems can also happen in people who have not had liver disease. Your healthcare provider may do tests to check your liver enzymes before and during treatment with ODEFSEY.
- Changes in body fat, which can happen in people taking HIV-1 medicines.
- Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking ODEFSEY.
- Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. Your healthcare provider may tell you to stop taking ODEFSEY if you develop new or worse kidney problems.
- Bone problems, such as bone pain, softening, or thinning, which may lead to fractures. Your healthcare provider may do tests to check your bones.
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?
- 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.
- 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.
- If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.
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.