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Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting
Date:12/7/2007

es 550 mg/m2

-- Prior use of other anthracyclines or anthracenediones should be

included in calculations of total cumulative dose

-- Cardiac toxicity may also occur at lower cumulative doses (400

mg/m2) in patients with prior mediastinal irradiation or who are

receiving concurrent cyclophosphamide therapy

-- Acute infusion-related reactions including, but not limited to,

flushing, shortness of breath, facial swelling, headache, chills, back

pain, tightness in 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/anaphylactoidlike 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

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SOURCE Ortho Biotech
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