Usual Adult Dose for Acute Myeloid Leukemia

12 mg/m2 daily for 3 days by slow (10 to 15 min) IV administration in combination with cytarabine
Maximum recommended cumulative lifetime dose for the IV formulation: 150 mg/m2

In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered.

Comment:

• Administration of the second course should be delayed in patients who experience severe mucositis until recovery has occurred, and a dose reduction of 25% is recommended.

Use: For the treatment of acute myeloid leukemia (AML) in combination with other approved antileukemic drug (including French-American-British [FAB] classifications M1 through M7)

Usual Adult Dose for Acute Nonlymphocytic Leukemia

12 mg/m2 daily for 3 days by slow (10 to 15 min) IV administration in combination with cytarabine
Maximum recommended cumulative lifetime dose for the IV formulation: 150 mg/m2

In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered.

Comment:

• Administration of the second course should be delayed in patients who experience severe mucositis until recovery has occurred, and a dose reduction of 25% is recommended.

Use: For the treatment of acute myeloid leukemia (AML) in combination with other approved antileukemic drug (including French-American-British [FAB] classifications M1 through M7)

Renal Dose Adjustments

• In patients with renal impairment, a dose reduction should be considered.

Liver Dose Adjustments

• In patients with hepatic impairment, a dose reduction should be considered.

Dose Adjustments

Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended.

Precautions

US BOXED WARNINGS:

• This drug should be given slowly into a freely flowing IV infusion. It should never be given IM or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.
• As with other anthracyclines, the use of this drug can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have preexisting cardiac disease.
• This drug can cause severe myelosuppression when it is used at effective therapeutic doses.
• This drug should be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution should be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
• Dosage should be reduced in patients with impaired hepatic or renal function

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

General:

• Patients over 60 years of age undergoing induction therapy experience congestive heart failure, serious arrhythmias, chest pain, myocardial infarction, and asymptomatic declines in LVEF more frequently than younger patients.
• Severe myelosuppression will occur in all patients given a therapeutic dose of this agent for induction, consolidation, or maintenance.

Reconstitution/preparation techniques:
Refer to the manufacturer product information.

IV compatibility:
Refer to the manufacturer product information.

Monitoring:

• Liver and kidney function should be evaluated with conventional clinical laboratory tests (using serum bilirubin and serum creatinine as indicators) prior to, and during, treatment.
• Hematologic function should be carefully monitored.
• Cardiac function should be monitored.

Patient advice:

• This drug may turn the urine red for 1 to 2 days after administration and patients should be advised that this is no cause for alarm.