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Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting

p> results of cardiac monitoring indicate possible cardiac injury, the

benefit of therapy must be weighed against the risk of myocardial


-- 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 greater than or equal to 15% over

baseline or a greater than or equal to 5% decrease below

institutional lower limit of normal)

-- Myelosuppression may occur; frequently monitor complete blood count

(including platelet count), at least prior to each dose of DOXIL

-- In patients with multiple myeloma, hematologic toxicity (based on

platelet count, absolute neutrophil count, hemoglobin level, or

neutropenia with fever) may require dose reduction, delay in

administration, or suspension of DOXIL and/or VELCADE

-- Persistent severe myelosuppression may result in superinfection,

neutropenic fever, or hemorrhage

-- Sepsis occurring during neutropenia has resulted in discontinuation

of treatment and in rare cases of death

-- DOXIL may potentiate the toxicity of other anticancer therapies,

especially hematologic toxicities, when used in combination with other

therapies that suppress bone marrow

-- Hand-foot syndrome (HFS) may occur during therapy with DOXIL

-- Based on HFS toxicity grade, dose reduction, delay in

administration, or discontinuation of DOXIL may be required

-- HFS was generally observed after 2 to 3 cycles of treatment, but may

occur earlier

-- The reaction was mild in most patients, resolving in 1 to 2 weeks

-- The reaction can be severe and debilitating in some patients,

resulting in

SOURCE Ortho Biotech
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