Bictegravir (bik-TEG-ra-vir), Emtricitabine (em-trye-SYE-ta-been), Tenofovir Alafenamide (ten-OF-oh-vir al-a-FEN-a-mide)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s):

Biktarvy

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even for a short time, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• Children who are not able to swallow a whole tablet may cut the medicine in half and take each part separately within 10 minutes.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the bottle tightly closed. Keep the medicine in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with dofetilide and rifampin.
• Some medicines can affect how bictegravir/emtricitabine/tenofovir alafenamide works. Tell your doctor if you are using any of the following:
  • Acyclovir, cidofovir, ganciclovir, gentamicin, metformin, rifabutin, rifapentine, St John's wort, sucralfate, valacyclovir, valganciclovir
  • Medicine to treat seizures (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
  • NSAID or pain reliever medicine
• Take this medicine at least 2 hours before or 6 hours after taking an antacid that contains aluminum or magnesium.
• You may take an antacid or supplement containing calcium or iron together with this medicine if you take them with food.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or become pregnant during treatment with this medicine.
• Tell your doctor if you have kidney disease or liver disease (including hepatitis B).
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Worsening of hepatitis B infection (if the medicine is stopped)
  • Liver problems
  • Kidney problems
  • Lactic acidosis (too much acid in the blood)
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, cloudy urine
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast breathing, trouble breathing, lightheadedness, severe weakness, tiredness, confusion

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088