Descovy® (emtricitabine/tenofovir alafenamide)
Crushing or Splitting of Tablets
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Descovy® (FTC/TAF)
Crushing or Splitting of Tablets
Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.
The full indication, important safety information, and boxed warnings are available at: www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.
Product Labeling1
There is no information in the FTC/TAF product label about the crushing or splitting of FTC/TAF; therefore, it is not recommended that FTC/TAF be administered as a crushed or split tablet.
The individual components of FTC/TAF, TAF and FTC, are each soluble in water.
Available Data on Crushing or Splitting FTC/TAF Tablets
Gilead Data
Crushing FTC/TAF tablets and adding to a liquid medium has not been studied and is not recommended. TAF is soluble in water; however, it has a bitter and burnt aromatic flavor profile.2 Currently, there are no studies evaluating the pharmacokinetics (eg, oral bioavailability) of a crushed FTC/TAF tablet dispersed in a liquid medium (eg, milk, water, or juice) and compared with the pharmacokinetics of a whole tablet.
Similarly, splitting FTC/TAF tablets has not been studied, and it is not recommended. Currently, there are no studies evaluating the pharmacokinetics of a split FTC/TAF tablet versus a whole tablet.
Non-Gilead Data
A literature search was conducted in Ovid MEDLINE, BIOSIS Previews, and Embase databases for studies published between 1946 and October 8, 2024, using the search terms Descovy, emtricitabine, tenofovir alafenamide, cutting, crushing, splitting tablets, and related search terms. The information presented below was found.
Case series and reports
There are limitations in the interpretation of case reports. Case reports cannot be generalized. Unlike controlled clinical trials, causality cannot be inferred based on uncontrolled observational data. Additionally, incidence or prevalence cannot be estimated due to the lack of a representative population sample. Other limitations of case reports include the retrospective design and publication bias.3
Crushed FTC/TAF tablets administered via PEG tube4
A 54-year-old male with HIV and squamous cell carcinoma of the tongue prepared pulverized FTC/TAF and dolutegravir 50 mg mixed in water and injected the mixture via a catheter syringe through a percutaneous endoscopic gastrostomy (PEG) tube, followed by administration of a can of enteral nutrition. Virologic suppression (viral load <20 copies/mL) was maintained at 8 and 10 months after FTC/TAF initiation, and no adverse events or intolerances were reported.
Other relevant reference(s)
- Kirkhope N, Foster C. Youth and antiretroviral therapy: to PEG or not to PEG? HIV Med. 2018;19(suppl 2):s71.
References
- Enclosed. Gilead Sciences Inc, DESCOVY® (emtricitabine and tenofovir alafenamide) tablets, for oral use. U. S. Prescribing Information. Foster City, CA.
- Gilead Sciences Inc. Data on File.
- Nissen T, Wynn R. The Clinical Case Report: A Review of Its Merits and Limitations. BMC research notes. 2014;7:264. https://www.ncbi.nlm.nih.gov/pubmed/24758689
- Fulco PP, Higginson RT. Enhanced HIV Viral Load Suppression with Crushed Combination Tablets Containing Tenofovir Alafenamide and Emtricitabine. Am J Health Syst Pharm. 2018;75(10):594-595. https://www.ncbi.nlm.nih.gov/pubmed/29748295
Product Label
For the full indication, important safety information, and boxed warning(s), please refer to the Descovy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or www.askgileadmedical.com
Adverse Event Reporting
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
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