Bictegravir, Emtricitabine, And Tenofovir Alafenamide (Oral Route)

Bictegravir, emtricitabine, and tenofovir alafenamide combination is used alone to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have yet to receive any medicine for their HIV infection or to patients to replace their current medicine provided that they meet certain requirements.

Bictegravir, emtricitabine, and tenofovir alafenamide combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Tablet

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of bictegravir, emtricitabine, and tenofovir alafenamide combination in children. Safety and efficacy have not been established.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Dofetilide
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum
• Calcium
• Carbamazepine
• Enzalutamide
• Eslicarbazepine Acetate
• Fosphenytoin
• Horsetail
• Iron
• Lumacaftor
• Magaldrate
• Magnesium
• Mitotane
• Orlistat
• Oxcarbazepine
• Phenytoin
• Rifabutin
• Rifapentine
• St John's Wort
• Sucralfate
• Tipranavir
• Tolvaptan
• Zinc

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults—1 tablet once a day. This medicine contains 50 milligrams (mg) bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
    • Children—Use and dose must be determined by your doctor.