Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Impact on Growth in Pediatric Patients
- During combination therapy for up to 48 weeks with PEGASYS plus ribavirin growth inhibition was observed in pediatric subjects 5 to 17 years of age. Decreases in weight for age z-score and height for age z-score up to 48 weeks of therapy compared with baseline were observed. At 2 years post-treatment, 16% of pediatric subjects were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve.
- The available longer term data on subjects who were followed up to 6 years post-treatment is too limited to determine the risk of reduced adult height in some patients [see Clinical Trials Experience (6.1)].
- Gastrointestinal disorders: tongue pigmentation
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.
- all Use with Ribavarin information removed from section
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)
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