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Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer
Date:12/14/2008

the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate - Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use - The initial rate of infusion should be 1 mg/min to minimize the risk of infusion reactions * Severe myelosuppression may occur * DOXIL dosage should be reduced in patients with impaired hepatic function * Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis Contraindications * Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL * Nursing mothers Additional Safety Information * Cardiac function should be carefully monitored - Congestive heart failure or cardiomyopathy may occur after discontinuation of anthracycline therapy - For patients with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury - In the randomized multiple myeloma study, 25 patients (8%) in the VELCADE for Injection arm and 42 patients (13%) in the VELCADE plus DOXIL arm experienced left ventricular ejection fraction decrease (defined as absolute decrease >/= 15% over baseline or a >/= 5% decrease below institutional lower limit of no
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SOURCE Ortho Biotech Products, L.P.
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