Uses of Bictegravir, Emtricitabine, and Tenofovir Alafenamide:

• It is used to treat HIV infection.

What do I need to tell my doctor BEFORE I take Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• If you are allergic to bictegravir, emtricitabine, and tenofovir alafenamide; any part of bictegravir, emtricitabine, and tenofovir alafenamide; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Kidney disease or liver disease.
• If you are taking any of these drugs: Dofetilide, rifabutin, rifampin, rifapentine, or St. John's wort.
• If you are taking any other drugs to treat HIV.
• If you are taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take bictegravir, emtricitabine, and tenofovir alafenamide.

This is not a list of all drugs or health problems that interact with bictegravir, emtricitabine, and tenofovir alafenamide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bictegravir, emtricitabine, and tenofovir alafenamide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• Tell all of your health care providers that you take bictegravir, emtricitabine, and tenofovir alafenamide. This includes your doctors, nurses, pharmacists, and dentists.
• Hepatitis B testing needs to be done as you were told by the doctor. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• This medicine interacts with many other drugs. The chance of bictegravir, emtricitabine, and tenofovir alafenamide's side effects may be raised or how well bictegravir, emtricitabine, and tenofovir alafenamide works may be lowered. The chance of the other drugs' side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take bictegravir, emtricitabine, and tenofovir alafenamide with all of your other drugs (prescription or OTC, natural products, vitamins).
• Kidney problems like kidney failure have happened with bictegravir, emtricitabine, and tenofovir alafenamide. Tell your doctor if you have ever had kidney problems.
• Rarely, bictegravir, emtricitabine, and tenofovir alafenamide may cause a swollen liver and a buildup of acid in the blood. Sometimes, this may be deadly. The risk may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using bictegravir, emtricitabine, and tenofovir alafenamide while you are pregnant.

How is this medicine (Bictegravir, Emtricitabine, and Tenofovir Alafenamide) best taken?

Use bictegravir, emtricitabine, and tenofovir alafenamide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking bictegravir, emtricitabine, and tenofovir alafenamide as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of bictegravir, emtricitabine, and tenofovir alafenamide during treatment.
• Do not take products that have iron in them or products like antacids that have aluminum, calcium, or magnesium in them at the same time as bictegravir, emtricitabine, and tenofovir alafenamide. Talk with your doctor or pharmacist.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
• Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take bictegravir, emtricitabine, and tenofovir alafenamide. Tell your doctor right away if you have any new signs after you start bictegravir, emtricitabine, and tenofovir alafenamide, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.

What are some other side effects of Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Upset stomach.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• Store in the original container at room temperature.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about bictegravir, emtricitabine, and tenofovir alafenamide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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