Hep C Discussion Forum

Tuesday, October 29, 2013 - FDA approved changes to the Incivek (telaprevir) product labeling to include results from trial C211 (OPTIMIZE) to support a twice daily dosing regimen.  In addition new contraindications were added for anticonvulsant medications (carbamazepine, phenobarbital and phenytoin) and other revisions to the section 7 Drug Interactions.

Below is a summary of the changes

 * Section 2:  Dosage and Administration of telaprevir were updated throughout the label: from 750 mg three times a day to 1125 mg twice daily.

* The anticonvulsant medications carbamazepine, phenobarbital, and phenytoin were moved from the Drug Interaction section (Section 7, Table 5) to the Contraindications section (Section 4, Table 3)

*Section 6:  Adverse Reactions was updated as follows:

Additional Data from Clinical Trials -

In the analysis of an additional study (Trial C211), the safety profile of combination treatment with INCIVEK 1125 mg twice daily was similar to the safety profile for patients receiving combination treatment with INCIVEK 750 mg every 8 hours (q8h) [see Clinical Studies (14.2)].  No new safety findings were identified.

* The analgesic medications alfentanil and fentanyl were added in section 7 Drug Interactions Table 5 as potential drug interaction drugs when used with telaprevir.  Specifically, careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when telaprevir is co-administered with alfentanil or fentanyl, including extended-release transdermal or transmucosal preparations of fentanyl.

Link to full details...

http://hcvadvocate.blogspot.ca/2013/10/fda-hepatitis-update-changes-to-incivek.html