Epclusa® (sofosbuvir/velpatasvir)

Storage and Stability

This document is in response to your request for extended storage and stability information of Epclusa® (sofosbuvir/velpatasvir [SOF/VEL]) 400/100 mg and 200/50 mg tablets and does not intend to offer an opinion regarding the clinical relevance of these data or the advisability of storing or administering any drug in a manner inconsistent with its approved labeling. Epclusa® (SOF/VEL) should be stored according to the product label.

The full indication, important safety information, and boxed warnings are available at:
www.gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.

Product Labeling1

Each bottle contains 28 tablets, polyester coil, and is closed with a child-resistant closure. Store below 30°C (86°F). Dispense only in original container.

Alternative Storage and Stability Information2

The table below summarizes available data from in-house studies regarding the storage of SOF/VEL tablets in varying conditions. The “acceptable duration” refers to the stability of SOF/VEL tablets in the specified packaging and storage condition, but it does not endorse alternative packaging or use beyond the expiration date stated on the original packaging.

Table 1. Summary of Extended Stability Data for SOF/VEL Tablets2

aTablets were stored outside of the commercial packaging configuration in an open petri dish in a stability chamber.

References

1. Enclosed. Gilead Sciences Inc, EPCLUSA® (sofosbuvir and velpatasvir) tablets, for oral use. US Prescribing Information. Foster City, CA.

2. Gilead Sciences Inc. Data on File.

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Epclusa US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_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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