Pegasys (Peginterferon alfa-2a) Drug Information: Overdosage and Contraindications

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May 27, 2012

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HCV is one of several viruses that cause hepatitis (inflammation of the liver).
Up to 85% of individuals who are initially (acutely) infected with HCV will fail to eliminate the virus and will become chronically infected.
HCV is spread most commonly through inadvertent exposure to infected blood. Intravenous drug abuse is the most common mode of transmission. The risk of acquiring HCV through sexual contact is low.
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In the U.S., Infection with HCV is the most common cause of chronic hepatitis and the most common reason for liver transplantation.
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OVERDOSE

There is limited experience with overdosage. The maximum dose received by any patient was 7 times the intended dose of PEGASYS (180 meg/day for 7 days). There were no serious reactions attributed to overdosages. Weekly doses of up to 630 meg 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.

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with:

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 in neonates and infants, which are sometimes fatal.

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: 8/22/2011
This monograph has been modified to include the generic and brand name in many instances.