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Based on results of clinical trials ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection; therefore, REBETOL® Capsules or Oral Solution must not be used alone.
The safety and efficacy of REBETOL Capsules and Oral Solution have only been established when used together with INTRON® A as a combination therapy or with PegIntron™ Injection.There are significant adverse events caused by REBETOL/INTRON A or PegIntron therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes.
Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up.The INTRON A and PegIntron package inserts should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.