Olysio® (simeprevir)

Are there any other warnings one should know regarding Olysio®?

UPDATE: Janssen Therapeutics discontinued Olysio effective May 25, 2018.

Use with Antiarrhythmic Drug Amiodarone

The FDA has warned that a serious slowing of the heart rate can occur when using amiodarone along with sofosbuvir in combination with Olysio particularly in those patients also receiving beta blockers or those who have underlying cardiac conditions and/or advanced liver disease. Taking amiodarone with Olysio and sofosbuvir is not recommended. For those patients that have no other hepatitis c treatment options, cardiac monitoring is recommended.

Ribavirin Cautions

When Olysio is prescribed for treatment along with ribavirin, the same warnings and precautions given regarding ribavirin should be observed, specifically avoiding pregnancy. Ribavirin may cause birth defects and/or death of the unborn baby. Pregnancy must be avoided in female patients as well as female partners of male patients. It is recommended that at least two forms of contraception be used during treatment and for at least 6 months after the completion of treatment.

Risk of Hepatitis B Reactivation

The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Olysio, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.

Hepatic Decompensation and Hepatic Failure

Hepatic decompensation and hepatic failure, including fatal cases have been reported in patients with advanced and/or decompensated cirrhosis. Your doctor should monitor liver chemistry tests before and during Olysio combination therapy.

Photosensitivity and Rash

Serious photosensitivity reactions have been observed during Olysio combination therapy. It is recommended that patients use sun protection and limit exposure during Olysio treatment. Discuss discontinuing treatment with your doctor if a severe rash or photosensitivity reactions occur.

Last Updated: May 2018