IMPORTANT SAFETY INFORMATION

What is the most important information to know?

Before taking TRUVADA for PrEP:

♦ You must be HIV-negative before you start taking TRUVADA for PrEP. You must get tested to make sure that you do not already have HIV-1. Do not take TRUVADA 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 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:

♦ You must continue to use 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:
Get tested for HIV-1 at least every 3 months.
If you think you were exposed to HIV-1, tell your healthcare provider right away.
♦ To further help reduce your risk of getting HIV-1:
Know your HIV status and the HIV status of your partners.
•Get tested for other sexually transmitted infections. Other infections make it easier for HIV to infect you.
•Get information and support to help reduce risky sexual behavior, such as having fewer sex partners.
•Do not miss any doses of TRUVADA. Missing doses may increase your risk of getting HIV-1 infection.

♦ 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:

♦ Worsening of hepatitis B (HBV) infection. TRUVADA is not approved to treat HBV. If you have HBV and stop taking TRUVADA, your HBV may suddenly get worse. Do not stop taking TRUVADA without first talking to your healthcare provider, as they will need to monitor your health.

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.
♦ Also take certain medicines to treat hepatitis B infection.

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. If you develop kidney problems, your healthcare provider may tell you to stop taking TRUVADA.

♦ Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.

♦ Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: 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, or stomach-area pain.

♦ Bone problems, including bone pain, softening, or thinning, which may lead to fractures. Your healthcare provider may do tests to check your bones.

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.

♦ 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.

♦ If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. If you become HIV-positive, HIV 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, your healthcare provider may need to check you more often or change your dose. These medicines include certain medicines to treat hepatitis C (HCV) infection.

What is TRUVADA for PrEP?

TRUVADA for PrEP (pre-exposure prophylaxis) is a prescription medicine that is used together with safer sex practices to help reduce the risk of getting HIV-1 through sex. This use is only for HIV-negative adults who are at high risk of getting HIV-1. To help determine your risk of getting HIV-1, talk openly with your healthcare provider about your sexual health.

Ask your healthcare provider if you have questions about how to prevent getting HIV. 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.

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.

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TRUVADA FOR PREP, the TRUVADA FOR PREP Logo, the TRUVADA Blue Pill Design, TRUVADA, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners. Version date: April 2017

© 2018 Gilead Sciences, Inc. All rights reserved.
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