FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions
Cinnamon Girl said
Apr 17, 2015
Thursday, April 16, 2015
FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions;
serious symptomatic bradycardia when co-administered with sofosbuvir and amiodarone
hepatic decompensation and hepatic failure.
Additional changes to the Indication and Usage, Dosage and Administration, Adverse Reactions, Drug Interactions, Use in Specific Populations and Pharmacokinetic sections of the label were made based on these Warnings and Precautions and are summarized below.
Link to full details and updated package insert...
Thursday, April 16, 2015
FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions;
serious symptomatic bradycardia when co-administered with sofosbuvir and amiodarone
hepatic decompensation and hepatic failure.
Additional changes to the Indication and Usage, Dosage and Administration, Adverse Reactions, Drug Interactions, Use in Specific Populations and Pharmacokinetic sections of the label were made based on these Warnings and Precautions and are summarized below.
Link to full details and updated package insert...
http://hcvadvocate.blogspot.ca/2015/04/fda-approved-changes-to-olysio.html