Idamycin PFS (idarubicin) for AML: Side Effects, Warnings



Generic drug: idarubicin hydrochloride

Brand name: Idamycin PFS

What is Idamycin PFS (idarubicin hydrochloride), and how does it work?

Idamycin PFS Injection (idarubicin hydrochloride) is a cancer (antineoplastic) medication used to treat a type of blood cancer (acute myeloid leukemia -AML) in adults. Idamycin PFS is available in generic form.

What are the side effects of Idamycin PFS?


  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

Common side effects of Idamycin PFS include:

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

What drugs interact with Idamycin PFS?

No information provided

Is Idamycin PFS safe to use while pregnant or breastfeeding?

  • 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.


What is leukemia?
See Answer

Medically Reviewed on 4/7/2021


All sections courtesy of the U.S. Food and Drug Administration


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