The Food and Drug Administration has approved changes to the warnings and precautions section of the package insert for Olysio (simeprevir).
One addition to the insert is that serious symptomatic bradycardia has been reported by individuals who have taken amiodarone with sofosbuvir and another HCV direct-acting antiviral, including Olysio.
Another change is the inclusion of a statement that hepatic decompensation and hepatic failure have been reported in patients treated with Olysio in combination with peginterferon alfa and ribavirin. Related to this finding, is the other new recommendation that patients with moderate or severe hepatic impairment not take Olysio.
More details on these and other related label changes for Olysio can be found at the FDA website.
