Epclusa® (sofosbuvir/velpatasvir)
Oral Pellets Storage and Stability Information

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Epclusa® (sofosbuvir/velpatasvir) Oral Pellets Storage and Stability

This document is in response to your request for extended storage and stability information of Epclusa® (sofosbuvir/velpatasvir [SOF/VEL]) 200 mg/50 mg and 150 mg/37.5 mg oral pellets 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 carton contains 28 packets. Store below 30°C (86°F). Do not use if carton tamper‑evident seal or packet has been opened or damaged.

Alternative Storage and Stability Information2

The table below summarizes available data from in-house studies regarding the storage of SOF/VEL oral pellets in varying conditions. The “acceptable duration” refers to the stability of SOF/VEL oral pellets 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 Oral Pellets2

Storage Condition

Package Type

Acceptable Duration

40°C (104°F)/75% relative humidity

Original packet

6 months

50°C (122°F)

Original packet

2 weeks

-20°C (-4°F)

Original packet

1 month

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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