Daunorubicin HCL - Cerubidine®
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|D5W1, NS1, or LR2|
Storage and Handling: 1
Other: Further dilution in D5W, LR, or NS is stable at room temperature (25°C) for up to 4 weeks if protected from light.2
|Stability / Miscellaneous|
Mechanism of Action
Cerubidine may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA.
Cerubidine possesses an antitumor effect against a wide spectrum of animal tumors, either grafted or spontaneous.
Metabolism and Elimination
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
It is recommended that the dosage of Cerubidine be reduced in instances of hepatic or renal impairment. For example, using serum bilirubin and serum creatinine as indicators of liver and kidney function, the following dose modifications are recommended:
Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia
For patients 60 years of age and above, Cerubidine 30 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This Cerubidine dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available.
The attainment of a normal-appearing bone marrow may require up to three courses of induction therapy. Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction treatment is required.
Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia
In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the Cerubidine dosage calculation should be based on weight (1 mg/kg) instead of body surface area.
Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia
Storage and Handling
If Cerubidine contacts the skin or mucosae, the area should be washed thoroughly with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
NDC 55390-281-10 20 mg, single dose vials; carton of 10.
1) [PACKAGE INSERT DATA] : Cerubidine (daunorubicin hydrochloride) injection, powder, for solution. Bedford Laboratories. Bedford, OH 44146. Revision Date June 2004.
2) Solimando, Dominic A. Drug Information Handbook for Oncology: A Complete Guide to Combination Chemotherapy Regimens, 8th ed. Hudson, OH: Lexi-Comp, Inc.; 2010.
Proper handling and disposal: Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15,1985. National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis R Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied HealthSciences, 179 Longwood Avenue, Boston, Massachusetts 02115. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1:426-428, 1983. Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca A Cancer Joumal for Clinicians Sept/Oct, 258-263, 1983. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 47:1033-1049, 1990. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines),Am J Health-Syst Pharm, 15:1669-1685
Cerubidine® (Daunorubicin HCL)