TRUVADA for a Pre-exposure
Prophylaxis (PrEP) Indication
TRUVADA is used with safer sex practices to reduce the risk of
getting HIV-1 in men who have sex with men who are at high risk of
getting infected with HIV through sex, and in heterosexual couples
where one partner has HIV-1 and the other does not. TRUVADA does
not cure HIV infection or AIDS.
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Risk Evaluation and Mitigation Strategy (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.
To make sure TRUVADA for PrEP is prescribed and taken safely, Gilead has worked with the FDA to develop materials for the REMS program to inform you about the risk of serious side effects.
IMPORTANT SAFETY INFORMATION
The most serious possible side effects of TRUVADA (emtricitabine/tenofovir disoproxil fumarate) are:
- Lactic acidosis (a buildup of acid in the blood), which is a serious, sometimes fatal, medical emergency. Symptoms of lactic acidosis include weakness, unusual muscle pain, trouble breathing, nausea, vomiting, a fast or irregular heartbeat, and/or feeling cold, dizzy or lightheaded
- Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis). Symptoms of liver problems include your skin or the whites of your eyes turning yellow (jaundice), dark colored urine, light colored stools, lack of appetite, nausea, and/or pain in your lower stomach area
- 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 or similar medicines 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
- If you have HIV-1 and hepatitis B virus (HBV) and stop taking TRUVADA, your hepatitis may suddenly get worse. Your healthcare provider will monitor your condition for several months
If you are an HIV-1 negative adult, your healthcare provider may prescribe TRUVADA to help reduce the risk of you getting HIV-1 infection through sex if you are at high risk (a man who has sex with men who are at high risk for getting HIV-1 through sex or if you are in a heterosexual couple where one partner is HIV-1 positive and the other is not). This use of TRUVADA is called Pre-exposure Prophylaxis or PrEP.
- If you are prescribed TRUVADA for PrEP the most important information you need to know is that you must be HIV-1 negative
- Before taking TRUVADA to help prevent getting HIV-1 infection through sex you must be tested to be completely sure you do not have HIV. You will also need to be tested regularly (every 3 months) to confirm you remain HIV-1 negative. This is because TRUVADA alone is not a complete treatment for HIV-1 infection and you may develop resistance which will make your infection harder to treat
- You must always practice safer sex. Use a condom, know your HIV status and that of your partner(s), get tested for other sexually transmitted infections (like syphilis and gonorrhea) and take action to limit your contact with body fluids
- If you have symptoms like fever, feeling tired, sweating a lot (especially at night), rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat and/or enlarged lymph nodes (especially in your neck or groin), and you may have been recently exposed to HIV (i.e., had unprotected sex) these may be symptoms of HIV infection, so tell your healthcare provider immediately
- Take your dose of TRUVADA every day, as prescribed by your healthcare provider and see your healthcare provider regularly
- Do not take TRUVADA to prevent sexually acquiring HIV-infection if you are HIV positive or do not know your status
- See the Medication Guide for further information about using TRUVADA for PrEP
Do not take TRUVADA if you also take products containing emtricitabine or tenofovir disoproxil fumarate (a/k/a tenofovir DF) [ATRIPLA (efavirenz/emtricitabine/tenofovir DF), COMPLERA (emtricitabine/rilpivirine/tenofovir DF), VIREAD (tenofovir DF), EMTRIVA (emtricitabine), STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir DF)] or products containing lamivudine [Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine)] because these medicines contain the same or similar active ingredients. TRUVADA should also not be used with HEPSERA (adefovir dipivoxil).
Other serious side effects include:
- New or worsening kidney problems: If you have had kidney problems or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys
- Bone problems: Lab tests show changes in the bones of patients treated with VIREAD (tenofovir DF), a medicine in TRUVADA. Some patients treated with VIREAD developed softening or thinning of the bones which could lead to fractures
- Changes in body fat: Changes in the distribution of body fat have been seen in some people taking TRUVADA and other anti-HIV-1 medicines. The long term health effect of this is not known
- Symptoms of inflammation: In some patients with advanced HIV-1 infection (AIDS), symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. If you notice any symptoms of infection, tell your healthcare provider right away
Common side effects include:
- The most common side effects of the medicines in TRUVADA when taken with other anti-HIV-1 medicines are diarrhea, dizziness, nausea, headache, fatigue, abnormal dreams, sleeping problems, rash, and depression
- Stomach area (abdomen) pain, headache and decreased weight have been reported in adults taking TRUVADA alone for pre-exposure prophylaxis
Before taking TRUVADA to help treat HIV-1 infection, tell your healthcare provider if you:
- Are pregnant or plan to become pregnant: It is not known if TRUVADA can harm your unborn baby, so speak to your healthcare provider about the risk of using TRUVADA while pregnant
- Are breastfeeding: Women with HIV should not breastfeed, because HIV can be passed through breast milk to the baby. Also, TRUVADA can pass into your breast milk, and it is not known if this will harm your baby. Talk to your healthcare provider about the best way to feed your baby
- Have or had liver, kidney, or bone problems, including hepatitis virus infection or if you have ever been on dialysis
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider may need to follow you more closely or adjust your therapy if you take Videx EC (didanosine), Reyataz (atazanavir sulfate), or Kaletra (lopinavir/ritonavir) with TRUVADA to treat HIV-1 infection.
These are not all the side effects of TRUVADA. If you have any questions about side effects, talk to your healthcare provider. Please see the full Prescribing Information with Medication Guide for more information about using TRUVADA.
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.