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. In addition, no data is available on splitting Biktarvy tablets in half, and this practice is not advised. There is no commercially available liquid formulations of Biktarvy in the U.S.
The prescribing information for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide fumarate or BIC/FTC/TAF) does not contain information about crushing or splitting the tablet before administration.
No pharmacokinetic studies are available that have evaluated a crushed Biktary tablet in a liquid (eg, milk, water, juice) compared to a whole tablet, or a split vs. whole tablet. Pharmacokinetic studies would give information about how crushing or splitting 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 (3 lbs).
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 to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.
How should I take Biktarvy?
Take Biktarvy exactly as your doctor prescribes. Do not crush, split 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.
If you take a multivitamin or mineral supplement that contains iron or calcium, take it with food at the same time you take Biktarvy.
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.
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 split or crush a Biktarvy tablet.
The manufacturer of Biktarvy states that crushing and dissolving or splitting tablets is not recommended. Do not crush or split 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) 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 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.
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.
- Bioequivalence of Solid/Crushed/Dissolved Forms of Biktarvy (SOLUBIC). ClinicalTrials.gov. US Library of Medicine/NIH. Accessed August 4, 2021 at https://clinicaltrials.gov/ct2/show/NCT04244448
- Lozano AB, Chueca N, De salazar A, et al. Failure to Biktarvy and development of resistance mutations in an antiretroviral-experienced patient. Antiviral Res. 2020;104717. DOI: 10.1016/j.antiviral.2020.104717
- Fulco PP. Crushed bictegravir/emtricitabine/tenofovir alafenamide in a human immunodeficiency virus-positive patient with esophageal cancer. Am J Health Syst Pharm. 2020;77(7):509-510. DOI: 10.1093/ajhp/zxaa017
- Oral antiretroviral/HCV DAA Administration: Information on Crushing and Liquid Drug Formulations. Toronto General Hospital. May 2020. Accessed August 4, 2021 at https://www.hivclinic.ca/main/drugs_extra_files/Crushing%20and%20Liquid%20ARV%20Formulations.pdf
- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]). Crushing or splitting of tablets. Data on File. Gilead US, updated Sept 9, 2020. Accessed August 4, 2021.
- Crushing Guide for Oral Medication in Residential Aged Care. Waitemata District Health Board, New Zealand. Accessed August 4, 2021 at https://www.saferx.co.nz/assets/Documents/9a2c1237a5/RAC_crushing_intro.pdf
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