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U.S. Department of Health and Human Services

Safety

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Sylatron (peginterferon alfa-2b)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

August 2014

Summary View

USE IN SPECIFIC POPULATIONS

Renal Impairment
  • Reduce the dose of SYLATRON by 25% in patients with moderate renal impairment (CLcr 30 to 50 mL/min/1.73m2) and 50% in patients with severe renal impairment (CLcr < 30 mL/min/1.73m2) or ESRD requiring dialysis. A study in subjects with varying degrees of renal impairment showed that the mean exposure (AUC) to peginterferon alfa-2b increased in subjects with moderate and severe renal impairment or ESRD requiring dialysis, as compared to subjects with normal renal function (CLcr > 80 mL/min/1.73m2) following a single 4.5 mcg/kg dose of peginterferon alfa-2b

MEDICATION GUIDE

What should I tell my healthcare provider before taking Sylatron?:

  • … or are receiving kidney dialysis treatment

 

December 2012

Summary View 

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 

Summary View

 

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