Cardiotoxicity; Myelosuppression; Renal/Hepatic Impairment; Avoid Extravasation
Injection for Intravenous Use
- Idarubicin hydrochloride for injection, USP) 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.
- As is the case with other anthracyclines the use of IDAMYCIN 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.
- As is usual with antileukemic agents, severe myelosuppression occurs when IDAMYCIN is used at effective therapeutic doses.
Experienced Physician/Equipped Facilities
- It is recommended that idarubicin 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.
Reduced Dose in Hepatic/Renal Impairment
- Dosage should be reduced in patients with impaired hepatic or renal function. (See DOSAGE AND ADMINISTRATION.)
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Facility must be capable of responding rapidly to severe hemorrhagic conditions and overwhelming conditions.
- Monitor cardiac, liver and renal function, and hematologic parameters during therapy
- Liver, cardiac and kidney function assessed prior to therapy.