Rebetol (Ribavirin) Drug Information: Medication Guide and Patient Information

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May 27, 2012

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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.
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PATIENT INFORMATION

[See FDA-Approved Medication Guide]

Anemia

The most common adverse experience occurring with REBETOL (ribavirin) Capsules is anemia, which may be severe [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Patients should be advised that laboratory evaluations are required prior to starting therapy and periodically thereafter [see DOSAGE AND ADMINISTRATION]. It is advised that patients be well hydrated, especially during the initial stages of treatment.

Pregnancy

Patients must be informed that REBETOL (ribavirin) Capsules and Oral Solution may cause birth defects and death of the unborn child. REBETOL (ribavirin) must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking REBETOL (ribavirin) . REBETOL (ribavirin) should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months post therapy. Women of childbearing potential must be counseled about use of effective contraception (two reliable forms) prior to initiating therapy. Patients (male and female) must be advised of the teratogenic/embryocidal risks and must be instructed to practice effective contraception during REBETOL (ribavirin) and for 6 months post therapy. Patients (male and female) should be advised to notify the physician immediately in the event of a pregnancy [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and Use In Specific Populations].

If pregnancy does occur during treatment or during 6 months post therapy, the patient must be advised of the teratogenic risk of REBETOL (ribavirin) therapy to the fetus. Patients, or partners of patients, should immediately report any pregnancy that occurs during treatment or within 6 months after treatment cessation to their physician. Physicians should report such cases by calling 1-800-593-2214.

Risks versus Benefits

Patients receiving REBETOL (ribavirin) Capsules should be informed of the benefits and risks associated with treatment, directed in its appropriate use, and referred to the patient MEDICATION GUIDE. Patients should be informed that the effect of treatment of hepatitis C infection on transmission is not known, and that appropriate precautions to prevent transmission of the hepatitis C virus should be taken.

Patients should be informed about what to do in the event they miss a dose of REBETOL (ribavirin) ; the missed dose should be taken as soon as possible during the same day. Patients should not double the next dose. Patients should be advised to contact their healthcare provider if they have questions.

Last reviewed on RxList: 12/3/2010
This monograph has been modified to include the generic and brand name in many instances.