Idamycin Pfs (idarubicin HCl)

Hepatic or renal impairment may affect the disposition of idarubicin. The patient's hepatic and renal function should be evaluated prior to administration of idarubicin, and a dosage reduction should be considered if serum bilirubin and/or creatinine concentrations exceed the normal range. In several phase 3 clinical trials, idarubicin therapy was withheld in patients with serum bilirubin or creatinine concentrations exceeding 2 mg/dL. In one trial, patients with serum bilirubin concentrations of 2.6-5 mg/dL received idarubicin with a 50% reduction in dose. Idarubicin should not be given to patients who have a serum bilirubin concentration exceeding 5 mg/dL.

Idarubicin is administered by IV injection. The drug is extremely irritating to tissues and, therefore, must not be given IM or subcutaneously. Care should be taken to avoid extravasation of the drug.

Idarubicin should be administered slowly (i.e., over 10-15 minutes) into a freely flowing IV infusion of 0.9% sodium chloride or 5% dextrose injection. The tubing for the IV infusion should be attached to a butterfly needle or other suitable device and preferably inserted into a large vein.

Although a stinging or burning sensation may be a symptom of extravasation during IV administration of idarubicin, extravasation may occur without these symptoms and even when blood returns well during initial aspiration of the infusion needle. If signs or symptoms of extravasation occur, administration of the drug should be discontinued immediately and the infusion restarted in another vein. In cases of known or suspected subcutaneous extravasation, intermittent ice packs (immediately for 30 minutes, then 30 minutes 4 times daily for 3 days) should be applied over the affected area and the involved extremity should be elevated. The involved extremity should be examined frequently, and plastic surgery consultation should be obtained promptly upon any sign of a local reaction (i.e., pain, erythema, edema, or vesication). In case of ulceration or severe persistent pain at the site of extravasation, early wide excision of the affected area should be considered.

Caution should be exercised in handling and preparing solutions of idarubicin. Because skin reactions may occur with accidental exposure to the drug, the manufacturer recommends the use of goggles, gloves, and protective gowns during preparation and administration of idarubicin. Skin accidentally exposed to the drug should be washed thoroughly with soap and water, and standard irrigation techniques should be used immediately in the event of eye involvement.

Parenteral idarubicin solutions should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The manufacturer states that idarubicin should not be mixed with other drugs (unless specific compatibility data are available). Precipitation occurs when the drug is mixed with heparin, and prolonged contact with any alkaline solution will cause degradation of idarubicin.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal studies of drug interactions with idarubicin have not been performed to date.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Idarubicin can cause fetal toxicity when administered to pregnant women, but potential benefits may be acceptable in certain conditions despite possible risks to the fetus. A case of a human fetal death following maternal exposure to idarubicin during the second trimester of pregnancy has been reported. When administered to rats at a dosage of 1.2 mg/m2 daily (equivalent to one-tenth the recommended human dosage), the drug was embryotoxic and teratogenic; this dosage was not toxic to dams. The drug was embryotoxic but not teratogenic in rabbits receiving 2.4 mg/m2 daily (equivalent to one-fifth the recommended human dosage), a dosage which was toxic to dams.

Adequate, well-controlled studies in pregnant women have not been conducted. Idarubicin should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective. When the drug is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus. Women of childbearing potential who are treated with idarubicin should be advised to avoid pregnancy. Men receiving idarubicin should be advised to use barrier contraception.

It is not known whether idarubicin or its metabolites are distributed into milk. Because of the potential for serious adverse reactions to idarubicin in nursing infants, nursing should be discontinued prior to idarubicin therapy.

No enhanced messaging available.