Important Safety Information
What is the most important information I should know about TRUVADA for PrEP?
Before taking TRUVADA for PrEP to reduce your risk of getting HIV-1 infection:
- You must be HIV-negative. You must get tested to make sure that you do not already have HIV-1 infection. Do not take TRUVADA for PrEP to reduce the risk of getting HIV-1 unless you are confirmed to be HIV-negative.
- Many HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting TRUVADA for PrEP or at any time while taking TRUVADA for PrEP. Symptoms of new HIV-1 infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting, diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.
While taking TRUVADA for PrEP to reduce your risk of getting HIV-1 infection:
- You must continue using safer sex practices. Just taking TRUVADA for PrEP may not keep you from getting HIV-1.
- You must stay HIV-negative to keep taking TRUVADA for PrEP.
- To further help reduce your risk of getting HIV-1:
- Know your HIV-1 status and the HIV-1 status of your partners.
- Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you.
- Get tested for other sexually transmitted infections. Other infections make it easier for HIV-1 to infect you.
- Get information and support to help reduce risky sexual behavior.
- Have fewer sex partners.
- Do not miss any doses of TRUVADA. Missing doses may increase your risk of getting HIV-1 infection.
- If you think you were exposed to HIV-1, tell your healthcare provider right away.
- If you do become HIV-1 positive, you need more medicine than TRUVADA alone to treat HIV-1. TRUVADA by itself is not a complete treatment for HIV-1. If you have HIV-1 and take only TRUVADA, your HIV-1 may become harder to treat over time.
TRUVADA can cause serious side effects:
- Too much lactic acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, nausea, vomiting, stomach-area pain, cold or blue hands and feet, feeling dizzy or lightheaded, and/or fast or abnormal heartbeats.
- Serious liver problems. Your liver may become large and tender, and you may develop fat in your liver. Symptoms of liver problems include your skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, and/or stomach-area pain.
- You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking TRUVADA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
- Worsening of hepatitis B (HBV) infection. If you also have HBV and take TRUVADA, your hepatitis may become worse if you stop taking TRUVADA. Do not stop taking TRUVADA without first talking to your healthcare provider. If your healthcare provider tells you to stop taking TRUVADA, they will need to watch you closely for several months to monitor your health. TRUVADA is not approved for the treatment of HBV.
Who should not take TRUVADA for PrEP?
Do not take TRUVADA for PrEP if you already have HIV-1 infection or if you do not know your HIV-1 status. If you are HIV-1 positive, you need to take other medicines with TRUVADA to treat HIV-1. TRUVADA by itself is not a complete treatment for HIV-1. If you have HIV-1 and take only TRUVADA, your HIV-1 may become harder to treat over time.
Do not take TRUVADA for PrEP if you also take lamivudine (Epivir-HBV) or adefovir (HEPSERA).
What are the other possible side effects of TRUVADA for PrEP?
Serious side effects of TRUVADA may also include:
- Kidney problems, including kidney failure. Your healthcare provider may do blood tests to check your kidneys before and during treatment with TRUVADA for PrEP. If you develop kidney problems, your healthcare provider may tell you to stop taking TRUVADA for PrEP.
- Bone problems, including bone pain or bones getting soft or thin, may lead to fractures. Your healthcare provider may do tests to check your bones.
- Changes in body fat, which can happen in people taking TRUVADA or medicines like TRUVADA.
Common side effects in people taking TRUVADA for PrEP are stomach-area (abdomen) pain, headache, and decreased weight. 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 TRUVADA for PrEP?
- All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, bone, or liver problems, including hepatitis virus infection.
- If you are pregnant or plan to become pregnant. It is not known if TRUVADA can harm your unborn baby. If you become pregnant while taking TRUVADA for PrEP, talk to your healthcare provider to decide if you should keep taking TRUVADA for PrEP.
Pregnancy Registry: A pregnancy registry collects information about your health and the health of your baby. There is a pregnancy registry for women who take medicines to prevent HIV-1 during pregnancy. For more information about the registry and how it works, talk to your healthcare provider.
- If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. The medicines in TRUVADA can pass to your baby in breast milk. If you become HIV-1 positive, HIV-1 can be passed to the baby in breast milk.
- All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRUVADA may interact with other medicines. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
- If you take certain other medicines with TRUVADA for PrEP, your healthcare provider may need to check you more often or change your dose. These medicines include ledipasvir with sofosbuvir (HARVONI).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.1-800-FDA-1088.
What is TRUVADA for PrEP (Pre-exposure Prophylaxis)?
TRUVADA is a prescription medicine that can be used for PrEP to help reduce the risk of getting HIV-1 infection when used together with safer sex practices. This use is only for adults who are at high risk of getting HIV-1 through sex. This includes HIV-negative men who have sex with men and who are at high risk of getting infected with HIV-1 through sex, and male-female sex partners when one partner has HIV-1 infection and the other does not.
Ask your healthcare provider if you have questions about how to prevent getting HIV-1. 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.
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