Can you crush Biktarvy tablets?

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. There is no commercially available liquid formulation of Biktarvy in the U.S.

For children unable to swallow a whole tablet, the lower dose pediatric tablet (containing 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF) can be split and each part taken separately as long as all parts are swallowed in about 10 minutes, according to the manufacturer.

The prescribing information for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide fumarate or BIC/FTC/TAF) does not contain information about crushing the tablet before administration.

Studies

No pharmacokinetic studies are available that have evaluated a crushed Biktary tablet in a liquid (eg, milk, water, juice) compared to a whole tablet. Pharmacokinetic studies would give information about how crushing the tablet would affect properties of the medicine such as absorption.

Studies evaluating the bioequivalence of solid, crushed and dissolved forms of Biktarvy are ongoing according to ClinicalTrials.gov.

Data on file from Gilead, the manufacturer of Biktarvy, states that tenofovir (TAF) and emtricitabine (FTC) are soluble in water, while bictegravir (BIC) is practically insoluble (solubility of 0.1 mg/mL in water at 20°C). TAF, when dissolved in water, has a bitter and burnt flavor.

Biktarvy tablets are film-coated, most likely to help mask the bitter flavor. In general, you should not crush film-coated tablets. The coating may be necessary to prevent rapid breakdown of the medicine or to hide the taste.

Biktarvy is a prescription medicine that is used without other HIV-1 medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children who weigh at least 14 kg (31 lbs):

• with no antiretroviral treatment history or
• with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir, or
• to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

In October 2021 the FDA approved a new low-dose tablet form of Biktarvy (bictegravir 30 mg / emtricitabine 120 mg / tenofovir alafenamide 15 mg) for children weighing at least 14 kg (31 lb) to less than 25 kg (55 lb) who are virologically suppressed or new to antiretroviral therapy.

Case Reports

There are case reports in the literature that document the use of crushed Biktarvy, but it is important to know that these results cannot always be generalized. These data are observational and uncontrolled and may not be applicable to you. Talk to your doctor first before you crush a Biktarvy tablet.

The manufacturer of Biktarvy states that crushing and dissolving tablets is not recommended. Do not crush Biktarvy unless your doctor prescribes it this way.

A 64-year old male patient with HIV received crushed Biktarvy tablets due to difficulty swallowing due to esophageal cancer and trouble swallowing (dysphagia).

• The patient crushed the tablet and diluted in 30 to 60 mL of water and then administered via a PEG tube followed by 240 mL of an enteral formula (Jevity).
• The patient’s viral load remained undetectable and was able to resume oral therapy after 10 months of cancer treatment.

A 39-year woman diagnosed with HIV and toxoplasmosis received nasogastric (NG) tube feeds due to acute neurologic deterioration, right hemiparesis (difficulty with movement) and dysphagia (trouble swallowing).

• Biktarvy was crushed and given as a solution in the NG tube for 6 weeks. Three months after starting Biktary her viral load increased and resistance testing showed several mutations.
• Therapy was switched to tenofovir alafenamide, emtricitabine and darunavir/ritonavir with only partial response.
• It is not known if failure was due to previous treatment failure with other antiretrovirals or due to administration of the crushed tablets.

Related questions

• Which medicines should not be taken with Biktarvy?
• What if I miss a dose of Biktarvy?
• Does Biktarvy cause weight gain?

How should I take Biktarvy?

Take Biktarvy exactly as your doctor prescribes. Do not crush or dissolve Biktarvy tablets unless your doctor tells you to. Typically, Biktarvy tablets are taken by mouth (swallowed whole) once a day. You may take Biktarvy with or without food.

For children unable to swallow a whole tablet, the lower dose pediatric tablet (containing 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF) can be split and each part taken separately as long as all parts are swallowed in about 10 minutes. The manufacturer states this in the professional package insert and patient information.

If you take a multivitamin or mineral supplement that contains iron or calcium, take it with food at the same time you take Biktarvy.

If you take an antacid or laxative containing aluminum (Al) or magnesium (Mg), Biktarvy can be taken at least 2 hours before OR 6 hours after taking the antacid or laxative. Regularly taking Biktarvy together with, or 2
hours after, antacids or laxative containing Al/Mg is not recommended.

Follow your healthcare provider instructions about any limitations on food, beverages, or activity. Ask your healthcare provider or pharmacist about medicines that should not be taken with Biktarvy.

This is not all the information you need to know about Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Biktarvy information here, and discuss this information and any questions you have with your doctor or other health care provider.

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