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

 

Hide
(web1)