"The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.
FDA advises consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 becau"...
There is limited experience with overdosage. The maximum dose received by any patient was 7 times the intended dose of PEGASYS (180 mcg/day for 7 days). There were no serious reactions attributed to overdosages. Weekly doses of up to 630 mcg 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:
- 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].
Last reviewed on RxList: 7/12/2013
This monograph has been modified to include the generic and brand name in many instances.
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