> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Epclusa Pediatric Label Changes Approved
- URL: https://www.fdaweb.com/epclusa-pediatric-label-changes-approved/
- Published: 2020-03-19T12:00:00.000Z
- Updated: 2026-09-14T16:08:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146370

FDA says it has approved changes to the labeling for Gilead’s Epclusa (sofosbuvir and velpatasvir) to provide for use in pediatric patients with chronic hepatitis C virus (HCV) ages six years and older or weighing at least 37 pounds with any of the six HCV genotypes without cirrhosis or with mild cirrhosis. An agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=313268&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=27a4de90d00e4685bc83ca18683f553d&elqaid=11691&elqat=1&ref=fdaweb.com) says that Epclusa in combination with ribavirin is indicated to treat pediatric patients age six and older or weighing at least 37 pounds with cirrhosis.

The most common adverse reactions observed with treatment with Epclusa were fatigue and headache. They were consistent with the adverse reactions observed in trials with adult patients.