PEGASYS is contraindicated in patients with:

• Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its components.
• Autoimmune hepatitis
• Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before treatment
• Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before treatment

PEGASYS is contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications which are sometimes fatal in neonates and infants.

PEGASYS/COPEGUS combination therapy is additionally contraindicated in:

• Women who are pregnant
• Men whose female partners are pregnant
• Patients with known hypersensitivity (urticaria, angioedema, bronchoconstriction, and anaphylaxis) to COPEGUS or to any component of the tablet
• Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
• Combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials [see Drug Interactions (7.4)].

^[1]

Adapted from the FDA Package Insert.