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WARNING

INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION

1. The use of DOXIL (doxorubicin HCl liposome injection) may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m². In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL (doxorubicin hcl liposome injection) at a starting dose of 50 mg/m² every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m² or between 500-550 mg/m², the risk of cardiac toxicity for patients treated with DOXIL (doxorubicin hcl liposome injection) was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see WARNINGS and PRECAUTIONS].
2. 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 (doxorubicin hcl liposome injection) . In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoidlike infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. DOXIL (doxorubicin hcl liposome injection) should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see WARNINGS and PRECAUTIONS].
3. Severe myelosuppression may occur [see WARNINGS and PRECAUTIONS)].
4. Dosage should be reduced in patients with impaired hepatic function [see DOSAGE AND ADMINISTRATION and Use in Specific Populations].
5. Accidental substitution of DOXIL (doxorubicin hcl liposome injection) for doxorubicin HCl has resulted in severe side effects. DOXIL (doxorubicin hcl liposome injection) should not be substituted for doxorubicin HCl on a mg per mg basis [see DOSAGE AND ADMINISTRATION].