Brand Name(s):

Biktarvy^®

IMPORTANT WARNING

Bictegravir, emtricitabine, and tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with bictegravir, emtricitabine, and tenofovir. If you have HBV and you take bictegravir, emtricitabine, and tenofovir, your condition may suddenly worsen when you stop taking bictegravir, emtricitabine, and tenofovir.

Keep all appointments with your doctor and the laboratory. Your doctor will examine you and order lab tests before, during, and regularly for several months after you stop taking bictegravir, emtricitabine, and tenofovir to see if your HBV has worsened.

Talk to your doctor about the risk(s) of taking bictegravir, emtricitabine, and tenofovir.

WHY is this medicine prescribed?

The combination of bictegravir, emtricitabine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in certain adults and children weighing at least 55 pounds (25 kg) who have not received antiretroviral treatment in the past or who have been stable on other antiretroviral treatment(s). Bictegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). Emtricitabine and tenofovir are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). The combination of bictegravir, emtricitabine, and tenofovir works by decreasing the amount of HIV in the body. Although bictegravir, emtricitabine, and tenofovir will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.

HOW should this medicine be used?

The combination of bictegravir, emtricitabine, and tenofovir comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take bictegravir, emtricitabine, and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bictegravir, emtricitabine, and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take bictegravir, emtricitabine, and tenofovir even if you feel well. Do not stop taking bictegravir, emtricitabine, and tenofovir without talking to your doctor. If you stop taking bictegravir, emtricitabine, and tenofovir even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking bictegravir, emtricitabine, and tenofovir,

tell your doctor and pharmacist if you are allergic to bictegravir, emtricitabine, and tenofovir, any other medications, or any of the ingredients in bictegravir, emtricitabine, and tenofovir tablets. Ask your pharmacist for a list of the ingredients.
tell your doctor if you are taking dofetilide (Tikosyn) or rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor will probably tell you not to take bictegravir, emtricitabine, and tenofovir if you are taking one of these medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acyclovir (Zovirax); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); cidofovir; ganciclovir (Valcyte); gentamicin; other medications to treat human immunodeficiency virus (HIV); metformin (Glucophage, Riomet); nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); oxcarbazepine (Trileptal); phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifapentine (Priftin); ritonavir (Norvir, in Kaletra); valacyclovir (Valtrex); and valganciclovir (Valcyte). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with bictegravir, emtricitabine, and tenofovir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
if you are taking an antacid containing calcium, magnesium, aluminum (Maalox, Mylanta, Tums, others) or sucralfate (Carafate), take bictegravir, emtricitabine, and tenofovir on an empty stomach 2 hours before you take the antacid or sucralfate.
if you are taking an iron or a calcium supplement, take it at the same time as bictegravir, emtricitabine, and tenofovir along with food.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in people with weak immune systems) or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking bictegravir, emtricitabine, and tenofovir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking bictegravir, emtricitabine, and tenofovir.
you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with bictegravir, emtricitabine, and tenofovir be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of bictegravir, emtricitabine, and tenofovir on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 2, 2019.