The Food and Drug Administration (FDA) has approved changes to the Olysio (simeprevir; Janssen) label to include new Warnings and Precautions.

The updated label now includes warnings about serious symptomatic bradycardia when co-administered with sofosbuvir and amiodarone; and hepatic decompensation and hepatic failure. There have been post-marketing reports of symptomatic bradycardia and cases requiring pacemaker intervention when amiodarone was given with sofosbuvir in combination with another hepatitis C virus (HCV) direct acting antiviral, including Olysio. It is not recommended to administer amiodarone with Olysio in combination with sofosbuvir. There have also been post-marketing reports of hepatic decompensation and hepatic failure, including fatal cases, when Olysio was given in combination with peginterferon alfa and ribavirin or in combination with sofosbuvir. It is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) to take Olysio.

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Other updates based on the new warnings and precautions are found in the following sections:

  • Limitations of Use: Hepatic impairment
  • Dosage and Administration: Combination treatment, Hepatic impairment
  • Adverse Reactions: laboratory abnormalities and post-marketing experience
  • Drug Interactions: Antiarrhythmic revisions
  • Specific Populations: Hepatic impairment
  • Pharmacokinetics: Special populations (hepatic impairment)

Olysio is a HCV NS3/4A protease inhibitor currently approved for the treatment of chronic hepatitis C genotype 1 infection as a component of a combination antiviral treatment regimen.

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