Label Changes for:

Pegasys (peginterferon alfa-2a)

September 2014

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

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

 

September 2014

Note: Multiple, extensive changes to many sections, and minor editorial or organizational changes in most sections, of the prescribing information including the Medication Guide and Instructions for Use (IFU). See the link to the full PI for details.

Brief Summary:

BOXED WARNING

  • all Use with Ribavarin information removed from section

4 CONTRAINDICATIONS

Additional contraindications for use with other HCV antiviral drugs:

  • When used in combination with other HCV antiviral drugs, all contraindications also apply to Pegasys combination therapy (4)
  • Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant

5 WARNINGS AND PRECAUTIONS

Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for their Warnings and Precautions.

5.1 Use with Ribavirin
  • Birth defects and fetal death: patients must have a negative pregnancy test prior to therapy, use 2 forms of effective contraception, and have monthly pregnancy tests
  • PEGASYS Clinically Significant Adverse Reactions or Risks
    Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:
  • Neuropsychiatric reactions (5.2)
  • Cardiovascular disorders (5.3)
  • Bone marrow suppression (5.4)
  • Autoimmune and endocrine disorders (including thyroid disorders; hyperglycemia) (5.5, 5.6)
  • Ophthalmologic disorders (5.7)
  • Cerebrovascular disorders (5.8)
  • Hepatic decompensation in cirrhotic patients. Exacerbation of hepatitis during hepatitis B treatment (5.9)
  • Pulmonary disorders (5.10)
  • Infections (bacterial, viral, fungal) (5.11)
  • Colitis and pancreatitis (5.13)


 

 

February 2011

ADVERSE REACTIONS

Immune system disorders
  • Liver graft rejection and renal graft rejection
Use in Specific Populations
  • Transplant Recipients-The safety and efficacy of Pegasys and Copegus treatment have not been established in patients with liver and other transplantations. As with other alpha interferons, liver and renal graft rejections have been reported on Pegasys, alone or in combination with Copegus

 

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