Important Safety Information

What is the most important information I should know about STRIBILD^®?

STRIBILD can cause serious side effects:

• Worsening of hepatitis B (HBV) infection. STRIBILD is not approved for the treatment of HBV. If you have both HIV-1 and HBV and stop taking STRIBILD, your HBV may suddenly get worse. Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health.

Who should not take STRIBILD?

Do not take STRIBILD if you take:

• Certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with STRIBILD. Do not start a new medicine without telling your healthcare provider.
• The herbal supplement St. John's wort.
• Any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera^®).

What are the other possible side effects of STRIBILD?

Serious side effects of STRIBILD may also include:

• New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD.
• 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 or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.
• 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 STRIBILD.

The most common side effects of STRIBILD include nausea and diarrhea. 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 STRIBILD?

• 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 nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider.
• If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD.
• If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD.
• 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.

What is STRIBILD?

STRIBILD is a prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or in people who are replacing their current HIV-1 medicines and whose healthcare provider determines that they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL of virus in their blood) for 6 months or more on their current HIV-1 treatment. STRIBILD combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single tablet regimen and should not be used with other HIV-1 medicines.

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