There is limited experience with overdosage. The maximum dose received by any patient was 7 times the intended dose of PEGASYS (180 mg/day for 7 days). There were no serious reactions attributed to overdosages. Weekly doses of up to 630 mg have been administered to patients with cancer. Dose-limiting toxicities were fatigue, elevated liver enzymes, neutropenia, and thrombocytopenia. There is no specific antidote for PEGASYS. Hemodialysis and peritoneal dialysis are not effective.

PEGASYS is contraindicated in patients with:

·Hypersensitivity to PEGASYS or any of its components

·Autoimmune hepatitis

·Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before or during treatment

·Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during 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 in neonates and infants, which are sometimes fatal.

PEGASYS and COPEGUS combination therapy is additionally contraindicated in:

·Patients with known hypersensitivity to COPEGUS or to any component of the tablet

·Women who are pregnant

·Men whose female partners are pregnant

·Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)

Bookmark this page: