Rebetron (Rebetol and Intron A Combination Therapy) Drug Information: Overdosage and Contraindications

Pill Identifier Search

May 27, 2012

Rebetron

Hepatitis C »

Hepatitis C infection facts

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.
Generally, patients do not develop symptoms of chronic infection with HCV until they have extensive scarring of the liver (cirrhosis). Some individuals, however, may have fatigue and other non-specific symptoms in the absence of cirrhosis. A minority of patients with HCV have symptoms from organs outside of the liver.
In the U.S., Infection with HCV is the most common cause of chronic hepatitis and the most common reason for liver transplantation.
...

Read the Hepatitis C article »

Rebetron

Hepatitis Slideshow Pictures

Digestive Disease Myths Slideshow Pictures

Infectious Mononucleosis Slideshow Pictures

font size

OVERDOSE

There is limited experience with overdosage. Acute ingestion of up to 20 grams of REBETOL Capsules, INTRON A ingestion of up to 120 million units, and subcutaneous doses of INTRON A up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse events related to the therapeutic use of INTRON A and REBETOL. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of INTRON A that exceed dosing recommendations.

There is no specific antidote for INTRON A or REBETOL, and hemodialysis and peritoneal dialysis are not effective for treatment of overdose of either agent.

CONTRAINDICATIONS

Combination REBETOL/INTRON A therapy must not be used by females who are pregnant or by males whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking combination REBETOL/INTRON A therapy. Combination REBETOL/INTRON A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Females of childbearing potential and males must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL Capsules. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064. See BOXED CONTRAINDICATIONS AND WARNINGS. See WARNINGS.

REBETOL Capsules in combination with INTRON A Injection is contraindicated in patients with a history of hypersensitivity to ribavirin and/or alpha interferon or any component of the capsule and/or injection.

Patients with autoimmune hepatitis must not be treated with combination REBETOL/INTRON A therapy.

Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.