Bictegravir, Emtricitabine, and Tenofovir Alafenamide

Bictegravir, emtricitabine, and tenofovir alafenamide (AF) 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.

The combination of bictegravir, emtricitabine, and tenofovir AF 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 AF are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). The combination of bictegravir, emtricitabine, and tenofovir AF works by decreasing the amount of HIV in the body. Although bictegravir, emtricitabine, and tenofovir AF 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.

The combination of bictegravir, emtricitabine, and tenofovir AF comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take bictegravir, emtricitabine, and tenofovir AF 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 AF exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If unable to swallow the bictegravir, emtricitabine, and tenofovir AF tablet whole, you can cut the tablet in half and swallow each half separately as long as they are both swallowed within 10 minutes of each other.

Continue to take bictegravir, emtricitabine, and tenofovir AF even if you feel well. Do not stop taking bictegravir, emtricitabine, and tenofovir AF without talking to your doctor. If you stop taking bictegravir, emtricitabine, and tenofovir AF 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.

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

Before taking bictegravir, emtricitabine, and tenofovir AF,

• 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 AF tablets. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with bictegravir, emtricitabine, and tenofovir AF. Make sure you have discussed any medications you are currently taking or plan to take before starting bictegravir, emtricitabine, and tenofovir AF with your doctor and pharmacist. Before starting, stopping or changing any medications while taking bictegravir, emtricitabine, and tenofovir AF, please get the advice of your doctor or pharmacist.
• The following nonprescription or herbal products may interact with bictegravir, emtricitabine, and tenofovir AF: nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) and St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking bictegravir, emtricitabine, and tenofovir AF. Do not start any of these medications while taking bictegravir, emtricitabine, and tenofovir AF without discussing you're your healthcare provider.
• if you are taking an antacid containing calcium, magnesium, aluminum (Maalox, Mylanta, Tums, others) or sucralfate (Carafate), take bictegravir, emtricitabine, and tenofovir AF 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 AF along with food.
• 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.

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

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

Bictegravir, emtricitabine, and tenofovir AF may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• headache

If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• decreased urination
• swelling of feet and ankles
• fatigue
• shortness of breath
• fast breathing
• fast or abnormal heartbeat
• stomach pain with nausea and vomiting
• cold or blue color of the hands and feet
• dark yellow or brown urine
• light-colored bowel movements
• yellowing of skin or eyes
• loss of appetite
• weakness
• fatigue
• dizziness or lightheadedness

Bictegravir, emtricitabine, and tenofovir AF may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). Do not remove the desiccant pack that comes in the bottle.

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://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.

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 AF 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.

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