The FDA has approved changes to the warnings and precautions label for simeprevir for the treatment of hepatitis C virus infection, indicating that it can cause hepatic decompensation and failure, and serious symptomatic bradycardia when co-administered with sofosbuvir and amiodarone, according to a news release from the FDA.
The FDA approved the changes to the simeprevir (Olysio, Janssen Therapeutics) package insert to update the Warnings and Precautions section after one fatal cardiac arrest was reported among patients taking amiodarone and ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and multiple fatal reports of hepatic decompensation and hepatic failure in patients treated with simeprevir in combination with pegylated interferon alfa and ribavirin or in combination with sofosbuvir (Sovaldi, Gilead Sciences), according to the release.
Additional changes to the Indication and Usage, Dosage and Administration, Adverse Reactions, Drug Interactions, Use in Specific Populations and Pharmaco kinetic sections of the insert were made based on the new Warnings and Precautions changes, according to the release.
In the FDA announcement, the clinical comment stated, “Postmarketing cases of hepatic decompensation with markedly elevated bilirubin levels have been reported. Monitor liver chemistry tests before and as clinically indicated during Olysio combination therapy. Patients who experience an increase in total bilirubin to greater than 2.5 times the upper limit of normal should be closely monitored.”
Simeprevir is not recommended for patients with moderate or severe hepatic impairment, according to the release.
The release further stated that co-administration of amiodarone with simeprevir in combination with sofosbuvir is not recommended and patients with underlying cardiac comorbidities, advanced liver disease or taking beta blockers may be at increased risk for symptomatic bradycardia with co-administration of amiodarone.
“If patients are taking sofosbuvir in combination with simeprevir who need to start amiodarone therapy due to no other alternative treatment options, they should undergo cardiac monitoring and receive counseling about the risk of serious symptomatic bradycardia,” the announcement read.
All changes to the labels will soon be available online at DailyMed, according to the release. – by Melinda Stevens