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

DESCOVY may cause serious side effects:

• Worsening of hepatitis B (HBV) infection. DESCOVY is not approved to treat HBV. If you have both HIV-1 and 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 monitor your health.

What are the other possible side effects of DESCOVY?

Serious side effects of DESCOVY may also include:

• 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 DESCOVY.
• 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 DESCOVY if you develop new or worse kidney problems.
• 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, 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 effect of DESCOVY 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 DESCOVY?

• 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.
• All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how DESCOVY 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 DESCOVY with all of your other medicines.
• If you are pregnant or plan to become pregnant. It is not known if DESCOVY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking DESCOVY.
• If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

WHAT IS DESCOVY?

DESCOVY is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people 12 years and older. DESCOVY is not for use to help reduce the risk of getting HIV-1 infection. DESCOVY combines 2 medicines into 1 pill taken once a day. Because DESCOVY by itself is not a complete treatment for HIV-1, it must be used together with other HIV-1 medicines.

DESCOVY does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking DESCOVY. 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.

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.