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Intron
A + Rebetol
(interferon alfa-2b + ribavirin)
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| INTRON®
A in combination with REBETOL (Ribavirin, USP)
Capsules is indicated for the treatment of chronic
hepatitis C in patients with compensated liver disease
previously untreated with alfa interferon therapy
or who have relapsed following alfa interferon therapy.
See REBETRON Combination Therapy package insert
for additional information. |
Rebetron
Combination Therapy Package Insert
Rebetron
Combination Warning
Who
should not take combination REBETOL/INTRON A therapy?
Side
Effects and Safety Information
www.rebetron.com
Articles
on Intron A + Rebetol Combination
WARNING
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.
Alpha interferons, including INTRON® A, cause
or aggravate fatal or life-threatening neuropsychiatric,
autoimmune, ischemic, and infectious disorders.
Patients should be monitored closely with periodic
clinical and laboratory evaluations. Patients
with persistently severe or worsening signs or
symptoms of these conditions should be withdrawn
from therapy. In many but not all cases these
disorders resolve after stopping INTRON A therapy.
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Who
should not take combination REBETOL/INTRON A therapy?
DO NOT USE these medicines
if:
YOU OR YOUR PARTNER ARE PREGNANT.
YOU
OR YOUR PARTNER INTEND TO BECOME PREGNANT AT
ANY TIME DURING TREATMENT OF DURING THE 6 MONTHS
AFTER TREATMENT.
YOU OR YOUR PARTNER BECOME PREGNANT DURING TREATMENT.
COMBINATION REBETOL/INTRON A THERAPY COULD CAUSE
DEATH, SERIOUS BIRTH DEFECTS, AND HARM TO YOUR
UNBORN CHILD. Therefore, both you and your partner
MUST USE EFFECTIVE CONTRACEPTION (two reliable
methods) DURING THERAPY AND FOR 6 MONTHS AFTER
STOPPING THERAPY.
You are allergic to any of the ingredients in
REBETOL® Capsules or INTRON® A Injection,
or to any alpha interferon.
You have autoimmune hepatitis (hepatitis caused
by cells in your body attacking each other).
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Articles on