Idamycin PFS Injection (idarubicin hydrochloride)

WARNING

1. Idamycin PFS Injection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.
2. As is the case with other anthracyclines the use of Idamycin PFS can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease.
3. As is usual with antileukemic agents, severe myelosuppression occurs when Idamycin PFS is used at effective therapeutic doses.
4. It is recommended that Idamycin PFS 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 must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
5. Dosage should be reduced in patients with impaired hepatic or renal function.

Common side effects of Idamycin PFS include:

• nausea
• vomiting
• abdominal or stomach cramps
• diarrhea
• headache
• facial flushing during administration
• eye irritation or tearing
• darkening of the nail beds and skin folds, and
• red-colored urine for 1 or 2 days following a dose

Temporary hair loss is a common side effect of Idamycin PFS. Normal hair growth should return after treatment with Idamycin PFS has ended.

For induction therapy in adult patients with AML the following dose schedule is recommended:

• Idamycin PFS Injection 12 mg/m² daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine.
• The cytarabine may be given as 100 mg/m² daily by continuous infusion for 7 days or as cytarabine 25 mg/m² intravenous bolus followed by cytarabine 200 mg/m² daily for 5 days continuous infusion.
• In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered.
• 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.
• In patients with hepatic and/or renal impairment, a dose reduction of Idamycin PFS should be considered. Idamycin PFS should not be administered if the bilirubin level exceeds 5 mg%.
• The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation.

• There are no adequate and well-controlled studies in pregnant women. If idarubicin is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus.
• Women of childbearing potential should be advised to avoid pregnancy. It is not known whether this drug is excreted in human milk.
• Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from idarubicin, mothers should discontinue nursing prior to taking this drug.