Biktarvy is a combination tablet containing bictegravir, emtricitabine, and tenofovir alafenamide, designed for oral use. It is available in two dosage strengths. Key inactive ingredients include croscarmellose sodium, magnesium stearate, and microcrystalline cellulose, with a film coating that contains iron oxides, polyethylene glycol, and talc.

How should I use this medication?

Take this medication by mouth with a glass of water. You can take it with or without food. If it upsets your stomach, take it with food. You may cut the tablet in half. This may help you swallow the tablet if the whole tablet is too big. Be sure to take both halves within 10 minutes. Do not take just one-half of the tablet. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make HIV resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

Take antacids with aluminum or magnesium in them at a different time of day than this medication. Take this medication 2 hours BEFORE or 6 hours AFTER these products.

Take products with calcium or iron in them at the same time you take this medication with food.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Bottles: Store below 30 degrees C (86 degrees F). Keep the container tightly closed. Keep this medication in the original container until you are ready to take it. Get rid of any unused medication after the expiration date.

Blister Pack: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• An unusual or allergic reaction to bictegravir, emtricitabine, tenofovir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Adefovir
• Any medication that contains lamivudine
• Dofetilide
• Rifampin

This medication may also interact with the following:

• Antacids
• Certain antibiotics, such as rifabutin, rifapentine, aminoglycosides
• Certain medications for seizures, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• Medications for viral infection, such as cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir
• Metformin
• Non-steroidal antiinflammatory drugs (NSAIDs)
• St. John's wort
• Sucralfate
• Supplements containing calcium or iron

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication.

HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV.

If you have hepatitis B, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication.

What are the most serious risks of this medication?

Do not stop taking this medication without first talking to your care team. If you have both HIV and hepatitis B, the symptoms of hepatitis B may worsen when you stop taking this medication. Your care team will check your liver and general health after treatment is stopped. You may need to take other medications if your hepatitis flares or returns.