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Bictegravir, emtricitabine, and tenofovir alafenamide (Oral)

Generic Name: bictegravir/emtricitabine/tenofovir alafenamide (bik-TEG-ra-vir, em-trye-SYE-ta-been, ten-OF-oh-vir al-a-FEN-a-mide)

Oral route(Tablet)

Warning: Post treatment acute exacerbation of hepatitis BSevere acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and hepatitis B virus (HBV) and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of bictegravir/emtricitabine/tenofovir alafenamide.Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue bictegravir/emtricitabine/tenofovir alafenamide. If appropriate, anti-hepatitis B therapy may be warranted .

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Commonly used brand name(s)

In the U.S.

  • Biktarvy

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiviral

Pharmacologic Class: Integrase Inhibitor

Uses for bictegravir, emtricitabine, and tenofovir alafenamide

Bictegravir, emtricitabine, and tenofovir alafenamide combination is used alone to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Bictegravir, emtricitabine, and tenofovir alafenamide is usually given to patients who have yet to receive any medicine for their HIV infection or to patients to replace their current medicine provided that they meet certain requirements.

Bictegravir, emtricitabine, and tenofovir alafenamide combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Bictegravir, emtricitabine, and tenofovir alafenamide will not keep you from spreading HIV to other people. People who receive bictegravir, emtricitabine, and tenofovir alafenamide may continue to have other problems usually related to AIDS or HIV disease.

Bictegravir, emtricitabine, and tenofovir alafenamide is available only with your doctor's prescription.

Before using bictegravir, emtricitabine, and tenofovir alafenamide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bictegravir, emtricitabine, and tenofovir alafenamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bictegravir, emtricitabine, and tenofovir alafenamide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bictegravir, emtricitabine, and tenofovir alafenamide combination in children weighing less than 25 kilograms (kg). Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of bictegravir, emtricitabine, and tenofovir alafenamide combination have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking bictegravir, emtricitabine, and tenofovir alafenamide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using bictegravir, emtricitabine, and tenofovir alafenamide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Carbamazepine
  • Dofetilide
  • Fosphenytoin
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Rifampin
  • St John's Wort

Using bictegravir, emtricitabine, and tenofovir alafenamide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abametapir
  • Aluminum
  • Apalutamide
  • Calcium
  • Capmatinib
  • Carbamazepine
  • Darolutamide
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Fosphenytoin
  • Horsetail
  • Iron
  • Lasmiditan
  • Leflunomide
  • Lumacaftor
  • Magaldrate
  • Magnesium
  • Mitotane
  • Orlistat
  • Oxcarbazepine
  • Phenytoin
  • Rifabutin
  • Rifapentine
  • St John's Wort
  • Sucralfate
  • Teriflunomide
  • Tipranavir
  • Tolvaptan
  • Zinc

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of bictegravir, emtricitabine, and tenofovir alafenamide. Make sure you tell your doctor if you have any other medical problems, especially:

  • Chronic kidney disease or
  • Fanconi syndrome (kidney disease), history of or
  • Hepatitis B infection, history of or
  • Kidney failure, history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe or
  • Liver disease, severe—Use is not recommended in patients with these conditions.

Proper use of bictegravir, emtricitabine, and tenofovir alafenamide

Take bictegravir, emtricitabine, and tenofovir alafenamide exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Bictegravir, emtricitabine, and tenofovir alafenamide comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have questions.

You may take bictegravir, emtricitabine, and tenofovir alafenamide with or without food.

Do not change the dose or stop using bictegravir, emtricitabine, and tenofovir alafenamide without checking first with your doctor. When your supply of bictegravir, emtricitabine, and tenofovir alafenamide is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of bictegravir, emtricitabine, and tenofovir alafenamide.

Take bictegravir, emtricitabine, and tenofovir alafenamide on an empty stomach 2 hours before using an antacid containing aluminum, magnesium, or calcium.

Dosing

The dose of bictegravir, emtricitabine, and tenofovir alafenamide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of bictegravir, emtricitabine, and tenofovir alafenamide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of HIV infection:
      • Adults and children weighing 25 kilograms (kg) or more—1 tablet once a day. Bictegravir, emtricitabine, and tenofovir alafenamide contains 50 milligrams (mg) bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
      • Children weighing less than 25 kg—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of bictegravir, emtricitabine, and tenofovir alafenamide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in its original container.

Precautions while using bictegravir, emtricitabine, and tenofovir alafenamide

It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks that you take bictegravir, emtricitabine, and tenofovir alafenamide. Blood and urine tests may be needed to check for any unwanted effects.

Do not use bictegravir, emtricitabine, and tenofovir alafenamide together with dofetilide (Tikosyn®) or rifampin (Rifadin®, Rimactane®).

Bictegravir, emtricitabine, and tenofovir alafenamide may cause a hepatitis B infection to worsen if you stop using it. Your doctor may check for the presence of hepatitis B before and during treatment with bictegravir, emtricitabine, and tenofovir alafenamide and for at least several months after your last dose.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Two rare but serious reactions to bictegravir, emtricitabine, and tenofovir alafenamide are lactic acidosis (too much acid in the blood) and liver toxicity. Call your doctor right away if you have abdominal or stomach pain, nausea, vomiting, decreased appetite, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

Bictegravir, emtricitabine, and tenofovir alafenamide does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.

Bictegravir, emtricitabine, and tenofovir alafenamide side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Stomach pain

Rare

  • Changes in behavior
  • thoughts or attempts of killing oneself

Incidence not known

  • Bloody urine
  • dark urine
  • decreased appetite
  • decreased frequency or amount of urine
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • general tiredness and weakness
  • hives or welts, itching, skin rash
  • increased blood pressure
  • increased thirst
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramping
  • nausea
  • right upper abdominal pain and fullness
  • sleepiness
  • stomach discomfort
  • swelling of the face, fingers, or lower legs
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Abnormal dreams
  • belching
  • bloated feeling
  • discouragement
  • dizziness
  • excess air or gas in the stomach or bowels
  • feeling of fullness
  • feeling sad or empty
  • headache
  • heartburn
  • indigestion
  • irritability
  • loss of interest or pleasure
  • passing gas
  • stomach upset
  • trouble concentrating
  • trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions