Side Effects and Safety Information

The most common side effects associated with REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) Injection are flu-like symptoms. (See IMPORTANT SAFETY INFORMATION, below.)

REBETOL Capsules can reduce the number of red blood cells you have, which are necessary for carrying the oxygen in your blood to body tissues. As a result, you may develop mild or moderate anemia, which lessens your ability to use oxygen and makes you feel more tired. Your doctor will measure the hemoglobin level in your blood while you are receiving treatment. (Hemoglobin is a part of the red blood cells that helps to carry oxygen to your tissues.)

If your side effects from REBETRON Combination Therapy are severe, your doctor may need to change your dose or stop treatment completely. You can also help yourself by trying some of the management tips in the section, Managing Your Illness.

For more information about side effects, see the section, Side Effects of INTRON® A.

IMPORTANT SAFETY INFORMATION
Anemia associated with therapy may exacerbate symptoms of coronary disease or deteriorate cardiac function. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.

The most common adverse experiences associated with REBETRON Combination Therapy are "flu-like" symptoms, such as headache, fatigue, pain in the muscles (myalgia), and fever, which appear to decrease in severity as treatment continues. Severe psychiatric adverse events, including depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicidal attempts, suicides), and rare instances of homicidal ideation have occurred during combination REBETOL/INTRON A therapy, both in patients with and without a previous psychiatric disorder.

 
Combination REBETOL/INTRON A therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping 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. Women of childbearing potential and men must use effective contraception (two reliable forms) during treatment and during the 6-month posttreatment follow-up period. 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®. 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.

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The Importance of Treatment
REBETRON Combination Therapy
  Benefits of REBETRON Combination Therapy
Who May Take REBETRON Combination Therapy?
What to Expect During REBETRON Combination Therapy
How REBETRON Combination Therapy Is Taken
Side Effects and Safety Information
INTRON® A Therapy