REBETOL Rx

Not for use as monotherapy. Risk of embryo-fetal toxicity. Women of childbearing potential: obtain negative pregnancy test immediately prior to initiation, during therapy, and during the 9-month period after completion. Advise to use effective contraception during and for 9 months (females of reproductive potential) or for 6 months (males w. female partners) post-therapy period. Risk of hemolytic anemia. Significant or unstable cardiac disease: not recommended. Do baseline CBC (and at weeks 2 and 4 or more often if needed), WBCs with differential, platelets, blood chemistry, and thyroid function tests. Reduce dose or discontinue if hemolytic anemia with significant initial drop in hemoglobin, pancreatitis, pulmonary infiltrates, pulmonary function impairment, new or worsening ophthalmologic disorders, severe decreases in neutrophils and platelets, hematologic, endocrine (eg, TSH), and hepatic abnormalities, dental/periodontal disorders, or weight loss and growth inhibition in children occur. Pre-existing cardiac disease: do ECGs prior to initiation and monitor during therapy. Discontinue if cardiovascular status deteriorates. Psychiatric disorders: temporarily reduce dose if mild depression occurs; discontinue if severe depression or suicidal ideation/attempt occurs. Pulmonary disorders. Autoimmune disorders. Organ transplant. Evaluate for ophthalmologic disorders. Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus or HIV infection. Maintain adequate hydration. Elderly. Nursing mothers.