logo
oncology header image
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.

Drug:   Idarubicin - Idamycin PFS®

Usual Diluents

NS,    D5W

Dilution Data

DILUTION SUMMARY

[Amount of drug] [Infusion volume] [Infusion rate]
Syringe:
[Prescribed dose ]  [Conc:  1 mg/ml]  [ 10-15 minutes]*
   *Administered slowly into the tubing of a freely running intravenous infusion of NS or D5W.

IVPB:
[Prescribed dose ]  [50 ml]  [ 10-15 minutes]*
   *See administration comments below.



Administration:
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.1

Incompatibility
Unless specific compatibility data are available, idarubicin HCl should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug.1

Storage
Store vials under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time
of use.1

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


Stability / Miscellaneous

WARNINGS CLINICAL PHARMACOLOGY INDICATIONS
DOSAGE AND ADMINISTRATION RECONSTITUTION / DILUTION HOW SUPPLIED
Note: double mouse click to return to the top of the page



WARNINGS
1. Idarubicin HCl 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 idarubicin HCl 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 idarubicin HCl is used at effective therapeutic doses.

4. It is recommended that idarubicin HCl 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 function. (See DOSAGE AND ADMINISTRATION.)

DESCRIPTION
Idarubicin HCl Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranoside, hydrochloride.

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.


CLINICAL PHARMACOLOGY

Mechanism of Action
Idarubicin HCl is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake compared with other anthracyclines.

INDICATIONS AND USAGE
Idarubicin HCl injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.


WARNINGS
Idarubicin is intended for administration under the supervision of a physician who is experienced in leukemia chemotherapy.

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
(See WARNINGS)

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
Caution in handling the solution must be exercised as skin reactions associated with idarubicin HCl may occur. Skin accidentally exposed to idarubicin HCl should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

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
Unless specific compatibility data are available, idarubicin HCl should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug.

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
Idarubicin HCl Injection Single Dose Polypropylene Vials:

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.


===============================================
IDAMYCIN PFS Injection (idarubicin hydrochloride injection)

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.

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:
1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society. 1999: 32-41.
2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC; Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National institutes of Health; 1992. US Department of Health and Human Services, Public Health Service Publication NIH 92-2621.
3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253: 1590-1591.
4. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. 1987 Available from Louis P. Jeffrey, Sc. D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.5.
Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426-428.
6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA Cancer J Clin. 1983; 33: 258-263.
7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47: 1033-1049.
8. Controlling Occupational Exposure to Hazardous Drugs (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996; 53: 1669-1685

< Disclaimer > top of page icon

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.
Medical Calculators - A thru Z
Lab Values - A thru Z