IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)

Induction Therapy

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12 mg/m2 intravenously over 10 to 15 minutes on days 1, 2, and 3 of induction in combination with cytarabine 100 mg/m2 by continuous intravenous infusion daily for 7 days or cytarabine 25 mg/m2 intravenous bolus followed by cytarabine 200 mg/m2 continuous intravenous infusion daily for 5 days. (2.1)

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IDAMYCIN PFS can be given as part of a combination regimen with other chemotherapeutic drugs. (2.1)

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Renal Impairment: Assess renal function prior to therapy. Reduce dosage in renal impairment. (2.3, 8.6)

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Hepatic Impairment: Assess hepatic function prior to therapy. Avoid or reduce dosage in hepatic impairment. (2.4, 8.7)

See full prescribing information for preparation and administration instructions. (2.5, 2.6)

Injection: 5 mg/5 mL (1 mg/mL), 10 mg/10 mL (1 mg/mL), and 20 mg/20 mL (1 mg/mL) solution in a single-dose vial. (3)

None. (4)

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Myelosuppression: Severe myelosuppression resulting in severe infection, septic shock, hemorrhage, or death may occur. Obtain complete blood counts prior to each treatment and closely monitor patients during treatment for possible clinical complications due to myelosuppression. (5.4)

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Tumor Lysis Syndrome: During treatment, monitor blood chemistries and manage promptly. Treat as clinically indicated. (5.5)

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Hypersensitivity: Monitor patients for hypersensitivity reactions and manage as clinically indicated. (5.6)

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Renal Impairment: Assess renal function prior to and during treatment. Reduce the dose in patients on dialysis or those with GFR <30 mL/min. (2.3, 5.7, 8.6)

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Hepatic Impairment: Obtain liver tests prior to and during therapy. Reduce dose in patients with serum bilirubin levels of 2.6 to 5 mg/dL. Avoid use in patients with serum bilirubin greater than 5 mg/dL. (2.4, 5.8, 8.7)

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Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (5.9, 8.1, 8.3)

Most common adverse reactions (≥30%) are infection, nausea/vomiting, alopecia, abdominal pain/diarrhea, hemorrhage, mucositis, dermatologic, mental status changes, and pulmonary disorders. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Lactation: Advise not to breastfeed. (8.2)

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Infertility: May impair fertility. (8.3)