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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 containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) Injection are "flu-like" symptoms,
such as headache, fatigue, 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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