Biktarvy: Uses, Side Effects and Dosage

What is Biktarvy used for?

Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and children who weigh at least 25 kg (55 lbs). Biktarvy is for people who do not have an HIV virus that is resistant to bictegravir or tenofovir.

How does Biktarvy work?

Biktarvy reduces the amount of HIV in your body and keeps it at a low level. Biktarvy also increases the CD4+ (T) cell count in your blood. CD4 cells are white blood cells that are important in helping your body to fight infection.

What are the ingredients in Biktarvy?

Each tablet has the following medicines: bictegravir (as bictegravir sodium), emtricitabine, tenofovir alafenamide (as tenofovir alafenamide hemifumarate)

Each tablet has the following ingredients that are not medicines: croscarmellose sodium, iron oxide black, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Biktarvy comes in the following dosage forms:

Biktarvy is available as purplish brown capsule-shaped tablets. Each tablet has 50 mg of bictegravir (equivalent to 52.5 mg of bictegravir sodium), 200 mg of emtricitabine and 25 mg of tenofovir alafenamide (equivalent to 28.0 mg of tenofovir alafenamide hemifumarate).

Do not take Biktarvy if:

• You are allergic to bictegravir, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (Read “What are the ingredients in Biktarvy?” above).

Serious Warnings and Precautions

• You may experience a “Flare-up” of Hepatitis B Virus infection if you also have hepatitis B and stop taking Biktarvy. This may result in your Hepatitis B infection becoming worse than before. Do not stop taking Biktarvy without your doctor’s advice. If you stop taking Biktarvy, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking Biktarvy, your doctor will still need to check your health and take blood tests regularly to check your liver.
• You are currently taking dofetilide* (Tikosyn^®)
• You are currently taking rifampin (Rofact^®)
• You are currently taking St. John’s wort (Hypericum perforatum), an herbal remedy used to treat depression and anxiety

*Not available in Canada

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Biktarvy. Talk about any health conditions or problems you may have, including if you:

• Have liver problems or a history of liver disease, including hepatitis B virus infection (see Serious Warnings and Precautions box and Serious Side Effects table).
• Have kidney problems. Kidney problems, including kidney failure, have occurred in patients taking tenofovir. If you have kidney problems and are taking Biktarvy along with certain medicines such as non-steroidal anti-inflammatory drugs, your kidney problems could get worse.
• Have lactic acidosis (high levels of acid in the blood). See the Serious Side Effects table for symptoms and contact your doctor right away if you get these symptoms.

Other warnings you should know about:

If you are pregnant or plan to become pregnant:

Tell your healthcare provider if you become pregnant while taking Biktarvy.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. This registry collects information about your health and your baby’s health. If you become pregnant while taking Biktarvy, talk with your doctor about taking part in this registry.

If you are breast-feeding or plan to breast-feed:

If you have HIV, there is the chance of passing the HIV virus to your baby if you breastfeed. The ingredients of Biktarvy can be passed to your baby in your breast milk and may cause harm to your baby. The HIV virus may become harder to treat if your baby has HIV-1 infection. If you are a woman who has or will have a baby, talk with your doctor about the risks of breastfeeding with HIV, ways to reduce these risks, and the best way to feed your baby.

Blood Sugar and Fat Levels:

Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Drugs that should not be taken with Biktarvy:

• Any other medicines that contain tenofovir (COMPLERA^®, DESCOVY^®, Delstrigo^®, GENVOYA^®, ODEFSEY^®, STRIBILD^®, Symtuza™, TRUVADA^®, VEMLIDY^®, VIREAD^®).
• Any other medicines that contain emtricitabine or lamivudine (COMPLERA, DESCOVY, Delstrigo^®, Dovato^®, EMTRIVA^®, GENVOYA, ODEFSEY, STRIBILD, Symtuza, TRUVADA, 3TC, Combivir^®, Heptovir^®, Kivexa^®, Triumeq^®, Trizivir^®).
• Adefovir dipivoxil (HEPSERA^®).

The following may interact with Biktarvy:

• Medicines used for treating HIV, containing:

  • atazanavir

• Antibiotics, used to treat bacterial infections including tuberculosis, containing:

  • rifabutin or rifapentine

• Anticonvulsants, used to treat epilepsy, such as:

  • carbamazepine, oxcarbazepine, phenobarbital or phenytoin

• Antacids for stomach ulcers, heartburn or acid reflux such as:

  • aluminium/magnesium hydroxide or calcium carbonate

• Mineral supplements and vitamins, containing:

  • calcium or iron

• Ulcer-healing medication, such as:

  • sucralfate

If you are not pregnant and taking:

• an antacid, a mineral supplement or vitamin containing magnesium, aluminum, calcium or iron, or an ulcer healing medication, take it at least 2 hours before or at least 2 hours after Biktarvy, or take it with Biktarvy together with food.

If you are pregnant and taking:

• an antacid containing magnesium or aluminum or an ulcer healing medication, take Biktarvy at least 2 hours before or at least 6 hours after you take these antacids or medications with or without food.
• a mineral supplement or vitamin containing calcium or iron, take Biktarvy at least 2 hours before or at least 6 hours after you take these supplements without food, or take Biktarvy together with these supplements with food.

How to take Biktarvy:

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Do not run out of Biktarvy. Refill your prescription or talk to your doctor before your Biktarvy is all gone.
• Do not stop taking Biktarvy without first talking to your doctor.

Usual dose:

Adults and children who weigh at least 25 kg (55 lbs): Take one tablet each day with or without food. Try to take the tablet at the same time each day.

Adults on Dialysis:

• If you are on dialysis, take your daily dose of Biktarvy following dialysis.

Overdose:

Missed dose:

It is important not to miss a dose of Biktarvy.

• If you miss a dose of Biktarvy and you notice within 18 hours of the time you usually take Biktarvy, take the tablet as soon as you can. Then take the next dose as usual.
• If you miss a dose of Biktarvy and you notice after 18 hours, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).

What are possible side effects from using Biktarvy?

Like all medicines, Biktarvy can have side effects. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Biktarvy, by other medicines you are taking at the same time or by the HIV infection. For this reason it is very important that you inform your doctor about any changes in your health.

Common side effects of Biktarvy are:

• Diarrhea.
• Headache.
• Nausea.
• Tiredness.
• Dizziness.
• Trouble sleeping.
• Abnormal dreams.

Less common side effects are indigestion, constipation, gas, depression, rash and thoughts of suicide.

Other side effects may include swelling in the face, lips, tongue, or throat (angioedema); hives (urticaria); increase in weight.

These are not all the possible side effects you may feel when taking Biktarvy.

If you experience any side effects not listed here, contact your healthcare professional.

Changes to your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.

• Autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment. Look for any other symptoms such as:

  • high temperature (fever), redness, rash or swelling
  • joint or muscle pain
  • numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body
  • palpitations (chest pain) or rapid heart rate

If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Bottles

• Store Biktarvy below 30 °C (86 °F).
• Keep Biktarvy in its original container and keep the container tightly closed.
• Do not use Biktarvy if the seal over the bottle opening is broken or missing.
• Keep this medicine out of reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the bottle after {EXP}. The expiry date refers to the last day of that month.

Blister Pack

• Store Biktarvy between 15-30 °C (59-86 °F).
• Keep Biktarvy in its original container.
• Do not use Biktarvy if the foil over the blister or the seal around the blister card is broken or missing.
• Keep this medicine out of reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister card after {EXP}. The expiry date refers to the last day of that month.

If you want more information about Biktarvy:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.gilead.ca, or by calling 1-866-207-4267.

Last Revised JUN 10, 2025

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 7K2

BIKTARVY^®, COMPLERA^®, DESCOVY^®, EMTRIVA^®, GENVOYA^®, HEPSERA^®, ODEFSEY^®, STRIBILD^®, TRUVADA^®, VEMLIDY^® and VIREAD^® are trademarks of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

© 2025 Gilead Sciences, Inc. All rights reserved.

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