Copegus (Ribavirin) Drug Information: Overdosage and Contraindications

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May 26, 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

No cases of overdose with COPEGUS have been reported in clinical trials. Hypocalcemia and hypomagnesemia have been observed in persons administered greater than the recommended dosage of ribavirin. In most of these cases, ribavirin was administered intravenously at dosages up to and in some cases exceeding four times the recommended maximum oral daily dose.

CONTRAINDICATIONS

COPEGUS (ribavirin) is contraindicated in:

Women who are pregnant. COPEGUS may cause fetal harm when administered to a pregnant woman. COPEGUS is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and PATIENT INFORMATION].

Men whose female partners are pregnant.
Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).
In 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].

COPEGUS and PEGASYS combination therapy is contraindicated in patients with:

Autoimmune hepatitis.
Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before treatment [see WARNINGS AND PRECAUTIONS].
Hepatic decompensation (Child-Pugh score greater than or equal to 6) in cirrhotic CHC patients coinfected with HIV before treatment [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.