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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, myalgia, and fever, which
appear to decrease in severity as treatment continues. Severe psychiatric
adverse events may manifest in patients receiving therapy with interferons,
including INTRON A therapy. DEPRESSION AND SUICIDAL BEHAVIOR,
INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES,
MAY OCCUR.
| 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 and during the 6 months after treatment stops, physicians
are encouraged to report such cases by calling (800) 727-7064.
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