Important Safety Information

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

DESCOVY may cause serious side effects:

• Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for 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 or give you HBV medicine.

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 that may have been hidden in your body. 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.

The most common side effect of DESCOVY is nausea. Tell your healthcare provider if you have any side effects that bother you or don't 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 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.

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.

Please see full Prescribing Information, including Patient Information with important warnings.