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Intron
A (Recombinant Interferon Alfa-2b)
- Monotherapy -
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| INTRON®
A (Interferon alfa-2b, recombinant) for Injection
is indicated for the treatment of chronic hepatitis
C in patients 18 years of age or older with compensated
liver disease who have a history of blood or blood-product
exposure and/or are HCV antibody positive. Studies
in these patients demonstrated that INTRON A
therapy can produce meaningful effects on this disease,
manifested by normalization of serum alanine aminotransferase
(ALT) and reduction in liver necrosis and degeneration. |
Intron
A Prescribing Information 
Intron
A Side Effects
Intron A Important Safety Information
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on Intron A Monotherapy
WARNING
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of these conditions should be withdrawn from therapy.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. |
| All
patients receiving INTRON A therapy experienced
mild-to-moderate side effects. Some patients experienced
more severe side effects, including neutropenia,
fatigue, myalgia, headache, fever, chills, and increased
SGOT. Other frequently occurring side effects were
nausea, vomiting, depression, alopecia, diarrhea,
and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR,
INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS,
AND COMPLETED SUICIDES, HAVE BEEN REPORTED IN ASSOCIATION
WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING
INTRON A THERAPY. |
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