Idarubicin - Idamycin PFS® |
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| The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. | ||||||||||
Usual Diluents |
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| NS, D5W | ||||||||||
Dilution Data |
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Administration: Incompatibility Storage Solutions diluted in D5W or NS for infusion are stable for 4 weeks at room temperature, protected from light. Syringe and IVPB solutions are stable for 72 hours at room temperature and 7 days under refrigeration.2
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| Stability / Miscellaneous | ||||||||||
DESCRIPTION Idarubicin HCl Injection is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-use-only vials. Each mL contains idarubicin HCI 1 mg and the following inactive ingredients: glycerin 25 mg and water for injection q.s. Hydrochloric acid is used to adjust the pH to a target of 3.5. Mechanism of Action INDICATIONS AND USAGE WARNINGS Idarubicin is a potent bone marrow suppressant. Idarubicin should not be given to patients with pre-existing bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk. Severe myelosuppression will occur in all patients given a therapeutic dose of this agent for induction, consolidation or maintenance. Careful hematologic monitoring is required. Deaths due to infection and/or bleeding have been reported during the period of severe myelosuppression. Facilities with laboratory and supportive resources adequate to monitor drug tolerability and protect and maintain a patient compromised by drug toxicity should be available. It must be possible to treat rapidly and completely a severe hemorrhagic condition and/or a severe infection. Pre-existing heart disease and previous therapy with anthracyclines at high cumulative doses or other potentially cardiotoxic agents are co-factors for increased risk of idarubicin-induced cardiac toxicity and the benefit to risk ratio of idarubicin therapy in such patients should be weighed before starting treatment with idarubicin. Myocardial toxicity as manifested by potentially fatal congestive heart failure, acute life-threatening arrhythmias or other cardiomyopathies may occur following therapy with idarubicin. Appropriate therapeutic measures for the management of congestive heart failure and/or arrhythmias are indicated. Cardiac function should be carefully monitored during treatment in order to minimize the risk of cardiac toxicity of the type described for other anthracycline compounds. The risk of such myocardial toxicity may be higher following concomitant or previous radiation to the mediastinal-pericardial area or in patients with anemia, bone marrow depression, infections, leukemic pericarditis and/or myocarditis. While there are no reliable means for predicting congestive heart failure, cardiomyopathy induced by anthracyclines is usually associated with a decrease of the left ventricular ejection fraction (LVEF) from pretreatment baseline values. Since hepatic and/or renal function impairment can affect the disposition of idarubicin, liver and kidney function should be evaluated with conventional clinical laboratory tests (using serum bilirubin and serum creatinine as indicators) prior to and during treatment. In a number of Phase III clinical trials, treatment was not given if bilirubin and/or creatinine serum levels exceeded 2 mg%. However, in one Phase III trial, patients with bilirubin levels between 2.6 and 5 mg% received the anthracycline with a 50% reduction in dose. Dose reduction of idarubicin should be considered if the bilirubin and/or creatinine levels are above the normal range. (See DOSAGE AND ADMINISTRATION.) Pregnancy Category D - Idarubicin was embryotoxic and teratogenic in the rat at a dose of 1.2 mg/m2/day or one tenth the human dose, which was nontoxic to dams. Idarubicin was embryotoxic but not teratogenic in the rabbit even at a dose of 2.4 mg/m2/day or two tenths the human dose, which was toxic to dams. There is no conclusive information about idarubicin adversely affecting human fertility or causing teratogenesis. There has been one report of a fetal fatality after maternal exposure to idarubicin during the second trimester. 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 DOSAGE AND ADMINISTRATION For induction therapy in adult patients with AML the following dose schedule is recommended: Idarubicin HCl 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 idarubicin HCl should be considered. Idarubicin HCl should not be administered if the bilirubin level exceeds 5 mg%. (See WARNINGS.) 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. (See CLINICAL STUDIES for doses used in U.S. clinical studies.) Preparation and Administration Precautions Care in the administration of idarubicin HCl will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of idarubicin HCl extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered. Idarubicin HCl should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection (0.9%) or 5% Dextrose Injection. The tubing should be attached to a butterfly needle or other suitable device and inserted preferably into a large vein. Incompatibility Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit. Handling and Disposal: Procedures for handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. HOW SUPPLIED Sterile single use only, contains no preservative. NDC 55390-215-01 5 mg/5 mL vial (1 mg/mL), individually boxed. NDC 55390-216-01 10 mg/10 mL vial (1 mg/mL), individually boxed. NDC 55390-217-01 20 mg/20 mL vial (1 mg/mL), individually boxed. Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use. =============================================== Single Dose Glass Vials: Sterile single use only, contains no preservative. NDC 0013-2200-01 5 mg/5 mL vial (1 mg/mL), single vials. NDC 0013-2201-01 10 mg/10 mL vial (1 mg/mL), single vials. NDC 0013-2202-01 20 mg/20 mL vial (1 mg/mL), single vials. Single Dose Cytosafe™ Vials: Sterile single use only, contains no preservative. NDC 0013-2576-91 5 mg/5 mL vial (1 mg/mL), single vials. NDC 0013-2586-91 10 mg/10 mL vial (1 mg/mL), single vials. NDC 0013-2596-91 20 mg/20 mL vial (1 mg/mL), single vials. Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use. |
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| Reference(s) | ||||||||||
| PRIMARY: 1) [PACKAGE INSERT DATA] : Idarubicin hydrochloride (Idarubicin Hydrochloride) injection, solution. [Bedford Laboratories] Bedford, OH 44146 Bedford, OH 44146. Revised: 08/2007. 2) Solimando, Dominic A. Drug Information Handbook for Oncology: A Complete Guide to Combination Chemotherapy Regimens, 8th ed. Hudson, OH: Lexi-Comp, Inc.; 2010. Procedures for handling and disposal: |
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Idarubicin – Idamycin PFS®
