Bictegravir, emtricitabine, and tenofovir

Generic name: Bictegravir, Emtricitabine, And Tenofovir
Brand names: Biktarvy
Dosage form: oral tablet (30 mg-120 mg-15 mg; 50 mg-200 mg-25 mg)
Drug class: Antiviral combinations

Usage of Bictegravir, emtricitabine, and tenofovir

Biktarvy is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Biktarvy is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). bictegravir, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Biktarvy is for use in adults and children who weigh at least 31 pounds (14 kilograms) who have not received HIV-1 medicines, or to replace their current HIV-1 medicines for those who meet certain requirements.

Biktarvy may also be used for purposes not listed in this medication guide.

Bictegravir, emtricitabine, and tenofovir side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Bictegravir, emtricitabine, and tenofovir may cause serious side effects. Call your doctor at once if you have:

  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
  • lactic acidosis--muscle pain or weakness, numbness or cold feeling, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, or feeling very weak or tired; or
  • liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

    • Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

    • Common side effects of bictegravir, emtricitabine, and tenofovir may include:

  • nausea, diarrhea; or
  • headache.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Bictegravir, emtricitabine, and tenofovir

    Some medicines can cause unwanted or dangerous effects when used with Biktarvy. Your doctor may need to change your treatment plan if you also use:

  • dofetilide; or
  • rifampin.

    • Tell your doctor if you have ever had:

  • liver disease (especially cirrhosis or hepatitis B); or
  • kidney disease.

    • Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines to control your infection. Your name may be listed on a pregnancy registry to track the effects of Biktarvy on the baby.

    Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

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    How to use Bictegravir, emtricitabine, and tenofovir

    Usual Adult Dose for HIV Infection:

    Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a dayUse: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

    Usual Pediatric Dose for HIV Infection:

    At least 14 to less than 25 kg: Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg orally once a dayAt least 25 kg: Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a dayComments:-For children at least 14 to less than 25 kg who are unable to swallow a whole tablet, the tablet can be split and each part can be taken separately as long as all parts are ingested within about 10 minutes.Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

    Warnings

    If you've ever had hepatitis B, it may become active or get worse after you stop using this medicine. You may need frequent liver function tests for several months.

    What other drugs will affect Bictegravir, emtricitabine, and tenofovir

    Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

    Certain antacids, laxatives, or buffered medicines can make Biktarvy much less effective when taken at the same time. Take your Biktarvy dose on an empty stomach, 2 hours before you take any of these other medicines.

    Many drugs can affect Biktarvy. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

    Popular FAQ

    If you miss one dose of Biktarvy (bictegravir, tenofovir, and emtricitabine), take the missed dose as soon as you remember it. If it is almost time for your next dose, just skip the missed dose and take your next dose at the regular time. Try not to miss doses. Taking your medicine as prescribed will help you to keep your HIV under control and help prevent drug resistance. Continue reading

    There is not a specific warning in the product label against alcohol (ethanol) consumption with Biktarvy, a medication used for HIV treatment. But drinking too much alcohol can damage your liver. Ask your doctor if it is safe and how much alcohol you can drink while taking Biktarvy. Continue reading

    Most commercial and government health insurance plans in the U.S. cover some portion of the cost for Biktary. Typically a person taking Biktarvy pays between $0 and $9 per month. Continue reading

    Crushing Biktarvy tablets and adding it to a liquid like water, milk or juice has not been studied and is not recommended by the manufacturer. Continue reading

    Hair loss (alopecia) with the use of Biktarvy has been reported in several case reports, but has not been described in Biktarvy clinical studies conducted by the manufacturer. Tenofovir alafenamide (TAF), the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) contained in Biktarvy may possibly lead to hair loss. Continue reading

    The generic name for Biktarvy is bictegravir, emtricitabine and tenofovir alafenamide. Biktary is a 3-drug combination used as a complete, once-daily, single tablet regimen for HIV treatment. Biktarvy is not a cure for HIV or AIDS and is not used for HIV prevention. Continue reading

    Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) can increase cholesterol levels due to the tenofovir alafenamide (TAF) component, but this does not appear to be a frequent or significant side effect. Continue reading

    Acne has not been reported as a side effect of Biktarvy in clinical studies. Rash is an uncommon side effect that occurred in less than 2% of patients taking this medicine. Other skin side effects, such as angioedema, Stevens-Johnson syndrome / toxic epidermal necrolysis, and urticaria (hives) have also been reported. Continue reading

    No, Biktarvy is not a protease inhibitor. It is a combination integrase inhibitor and reverse transcriptase inhibitor used in the treatment of people living with HIV. Continue reading

    If you miss one dose of Biktarvy (bictegravir, tenofovir, and emtricitabine), take the missed dose as soon as you remember it. If it is almost time for your next dose, just skip the missed dose and take your next dose at the regular time. Try not to miss doses. Taking your medicine as prescribed will help you to keep your HIV under control and help prevent drug resistance. Continue reading

    There is not a specific warning in the product label against alcohol (ethanol) consumption with Biktarvy, a medication used for HIV treatment. But drinking too much alcohol can damage your liver. Ask your doctor if it is safe and how much alcohol you can drink while taking Biktarvy. Continue reading

    Most commercial and government health insurance plans in the U.S. cover some portion of the cost for Biktary. Typically a person taking Biktarvy pays between $0 and $9 per month. Continue reading

    Hair loss (alopecia) with the use of Biktarvy has been reported in several case reports, but has not been described in Biktarvy clinical studies conducted by the manufacturer. Tenofovir alafenamide (TAF), the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) contained in Biktarvy may possibly lead to hair loss. Continue reading

    Crushing Biktarvy tablets and adding it to a liquid like water, milk or juice has not been studied and is not recommended by the manufacturer. Continue reading

    The generic name for Biktarvy is bictegravir, emtricitabine and tenofovir alafenamide. Biktary is a 3-drug combination used as a complete, once-daily, single tablet regimen for HIV treatment. Biktarvy is not a cure for HIV or AIDS and is not used for HIV prevention. Continue reading

    Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) can increase cholesterol levels due to the tenofovir alafenamide (TAF) component, but this does not appear to be a frequent or significant side effect. Continue reading

    Acne has not been reported as a side effect of Biktarvy in clinical studies. Rash is an uncommon side effect that occurred in less than 2% of patients taking this medicine. Other skin side effects, such as angioedema, Stevens-Johnson syndrome / toxic epidermal necrolysis, and urticaria (hives) have also been reported. Continue reading

    No, Biktarvy is not a protease inhibitor. It is a combination integrase inhibitor and reverse transcriptase inhibitor used in the treatment of people living with HIV. Continue reading

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