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Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer
Date:9/10/2009

se of doxorubicin HCl approaches 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/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

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