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Idamycin Pfs Generic Name & Formulations
Legal Class
Rx
General Description
Idarubicin HCl 1mg/mL; soln for IV infusion; preservative-free.
Pharmacological Class
Anthracycline.
See Also
How Supplied
Single-dose vials—contact supplier; PFS: Single-dose vials (5mL, 10mL, 20mL)—1
Manufacturer
Idamycin Pfs Indications
Indications
Acute myeloid leukemia, in combination with other antileukemic drugs.
Idamycin Pfs Dosage and Administration
Adult
Give by slow IV infusion (over 10–15mins). 12mg/m2 daily for 3 days (in combination with cytarabine). May give 2nd course if needed; if toxicity develops after 1st course, delay until resolved; reduce dose by 25%. Hepatic and renal impairment: consider reduce dose.
Children
Not established.
Idamycin Pfs Contraindications
Not Applicable
Idamycin Pfs Boxed Warnings
Boxed Warning
Extravasation. Myocardial toxicity. Severe myelosuppression. Hepatic or renal impairment.
Idamycin Pfs Warnings/Precautions
Warnings/Precautions
Administer under the supervision of an experienced physician. Avoid in pre-existing bone marrow suppression. Increased risk of myocardial toxicity in pre-existing cardiovascular disease, previous anthracycline therapy at high cumulative doses, concomitant or previous mediastinal pericardial irradiation, anemia, bone marrow suppression, infections, leukemic pericarditis and/or myocarditis. Monitor CBCs, cardiac, hepatic and renal function prior to and during treatment. Monitor for hyperuricemia, infections. Hepatic or renal impairment (see Adult). Avoid extravasation. Elderly. Pregnancy: avoid. Advise to use effective contraception during and for 6.5 months (females of reproductive potential) or for 3.5 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 14 days after the last dose).
Idamycin Pfs Pharmacokinetics
See Literature
Idamycin Pfs Interactions
Interactions
Concomitant drugs that suppress cardiac contractility or cardiotoxic drugs (eg, trastuzumab, cyclophosphamide, paclitaxel): not recommended; avoid use for at least 5 half-lives after discontinuing cardiotoxic drug (up to 7mos for trastuzumab).
Idamycin Pfs Adverse Reactions
Adverse Reactions
Myelosuppression (may be severe), GI upset, mucositis, abdominal pain, alopecia, rash, inj site reactions, cardiotoxicity (eg, CHF, arrhythmias, chest pain, MI, asymptomatic declines in LVEF).
Idamycin Pfs Clinical Trials
See Literature
Idamycin Pfs Note
Not Applicable
Idamycin Pfs Patient Counseling
See Literature
