Important Safety Information

What is the most important information I should know about DESCOVY for PrEP?

Before and while taking DESCOVY for PrEP:

• You must be HIV-negative before you start and while taking DESCOVY for PrEP. You must get tested for HIV-1 immediately before and at least every 3 months while taking DESCOVY. If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to confirm that you are still HIV-negative.
• Many HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. Tell your healthcare provider if you had a flu-like illness within the last month before starting or while taking DESCOVY. 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.
• DESCOVY by itself is not a complete treatment for HIV-1. Do not take DESCOVY for PrEP unless you are confirmed to be HIV-1 negative.
• DESCOVY does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
• To further help reduce your risk of getting HIV-1:
  • Do not miss any doses of DESCOVY. Missing doses may increase your risk of getting HIV-1.
  • Know your HIV status and the HIV status of your partners. If your partner is living with HIV, your risk of getting HIV is lower if your partner consistently takes HIV treatment every day.
  • Get tested for other STIs. Some STIs make it easier for HIV-1 to infect you.
  • Talk to your healthcare provider about all the ways to help reduce HIV risk.

DESCOVY can cause serious side effects:

• Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have HBV and stop taking DESCOVY, your HBV may suddenly get worse. Do not stop taking DESCOVY without first talking to your healthcare provider, as they will need to check your health or give you HBV medicine.

Who should not take DESCOVY for PrEP?

Do not take DESCOVY for PrEP if you:

• Already have HIV-1 or if you do not know your HIV-1 status. If you have HIV-1, you need to take other medicines with DESCOVY to treat HIV-1. If you have HIV-1 and take only DESCOVY, your HIV-1 may become harder to treat now and in the future.

What are the other possible side effects of DESCOVY for PrEP?

Serious side effects of DESCOVY may also include:

• Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before and during treatment with DESCOVY. If you develop kidney problems, your healthcare provider may tell you to stop taking DESCOVY.
• 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.

Common side effects in people taking DESCOVY for PrEP are diarrhea, nausea, headache, fatigue, and stomach pain. 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 DESCOVY for PrEP?

• All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis.
• All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. DESCOVY 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

What is DESCOVY for PrEP?

DESCOVY for PrEP (pre-exposure prophylaxis) is a once-daily prescription medicine for adults and adolescents at risk of HIV. It helps lower the chances of getting HIV through sex.

DESCOVY for PrEP is not for everyone:

• It is not for use in people assigned female at birth who are at risk of getting HIV from vaginal sex, because its effectiveness has not been studied.
• You must be HIV-negative before and while taking DESCOVY for PrEP.

Talk to a healthcare provider to see if DESCOVY for PrEP may be an option for you.

Please see Important Facts about DESCOVY for PrEP^®, including important warnings.