Depression and suicidal behavior, including suicidal ideation, suicidal attempts and completed suicides, have been reported in association with treatment with alfa interferons.
Important Safety Information Regarding U.S. Labeling for PEGINTRON(TM) Alpha interferons, including PEGINTRON(TM) and INTRON(R) A, 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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) and/or INTRON(R) A 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. INTRON(R) A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON(R) A or any component of the product, autoimmune hepatitis, and decompensated liver disease.
Incidence of adverse events
There are no new adverse events specific to PEGINTRON(TM) as compared
to INTRON(R) A; however, the incidence of some (eg, injection site
reactions, fever, rigors, nausea) were higher. The most common adverse
events associated with PEGINTRON(TM) were "flu-like" symptoms, occurring in
approximately 50% of patients, which may decrease in severity as treatment
continues. Application site disorders were common (47%), but all wer
|SOURCE Schering-Plough Corporation|
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