Label Changes for:
Sylatron (Peginterferon Alfa-2b)
December 2012
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2012
ADVERSE REACTIONS
Immunogenicity
- As with all therapeutic proteins, there is potential for immunogenicity. In a clinical study conducted in patients with melanoma, the incidence of binding antibodies to peg-interferon alfa-2b was approximately 35% (50/144 patients)…
July 2012
USE IN SPECIFIC POPULATIONS
Hepatic Impairment
- Sylatron has not been studied in patients with melanoma who have hepatic impairment. In patients treated for viral hepatitis, peginterferon alfa-2b treatment is contraindicated in those with moderate or severe hepatic impairment (Child-Pugh scores >6). Discontinue Sylatron if hepatic decompensation (Child-Pugh scores >6) occurs during treatment
