Human
Immunodeficiency
Virus

TAFFIC is a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1) in adults and children who weigh at least 25 kg.

• who have not received anti-HIV-1 medicines in the past, or
• to replace their current anti-HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). TAFFIC contains the medicines bictegravir, emtricitabine, and tenofovir alafenamide. It is not known if TAFFIC is safe and effective in children who weigh less than 25 kg.

TAFFIC does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

TAFFIC may cause serious side effects:

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

Patient who are taking following

• dofetilide
• rifampin
• any other medicines to treat HIV-1

Serious side effects of TAFFIC 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 TAFFIC.

Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking TAFFIC.

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 effects of TAFFIC in clinical studies were diarrhea, nausea, and headache. Tell your healthcare provider if you have any side effects that bother you or don’t go away.

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, antacids, laxatives, vitamins, and herbal supplements. TAFFIC and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist, and ask if it is safe to take TAFFIC with all of your other medicines.

If you are pregnant or plan to become pregnant. It is not known if TAFFIC can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking TAFFIC.

If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

• Store TAFFIC below 86°F (30°C).
• Keep TAFFIC in its original container.
• Keep the container tightly closed.

Keep TAFFIC and all medicines out of reach of children.

• Take TAFFIC exactly as your healthcare provider tells you to take it. TAFFIC is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.
• Take TAFFIC 1 time each day with or without food.
• Do not change your dose or stop taking TAFFIC without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment with TAFFIC.
• If you take antacids that contain aluminum or magnesium, take TAFFIC at least 2 hours before or 6 hours after you take these antacids.
• If you take supplements or antacids that contain iron or calcium, take TAFFIC with food at the same time that you take these supplements or antacids.
• Do not miss a dose of TAFFIC.
• If you take too much TAFFIC, call your healthcare provider or go to the nearest hospital emergency room right away.
• When your TAFFIC supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TAFFIC and become harder to treat.