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Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
Date:7/11/2008

EF="http://www.schering-plough.com" target="_new">http://www.schering-plough.com and for Europe at http://www.emea.europa.eu/humandocs/PDFs/EPAR/Pegintron/H-280-PI-en.pdf.

Important Safety Information

Alpha interferons, including PEGINTRON(TM), may 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 PEGINTRON(TM) therapy.

PEGINTRON(TM) is contraindicated in patients with hypersensitivity to PEGINTRON(TM) or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic CHC patients before or during treatment.

Psychiatric adverse events, which include insomnia, were common with PEGINTRON(TM). Depression was most common. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in one percent of patients during or shortly after completing treatment with PEGINTRON(TM). The following serious or clinically significant adverse events have been reported at a frequency less than or equal to one percent with PEGINTRON(TM): Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

Additional Safety
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SOURCE Schering-Plough
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