Drug: Cerubidine

Cerubidine (daunorubicin hydrochloride) is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a sterile reddish lyophilized powder in vials for intravenous administration only. Each vial contains 21.4 mg daunorubicin hydrochloride (equivalent to 20 mg of daunorubicin), and 100 mg mannitol. It is soluble in water when adequately agitated and produces a reddish solution. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside hydrochloride. Its molecular formula is C27H29NO10•HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 4.5 to 6.5. The structural formula is as follows:

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Dose-limiting toxicity includes myelosuppression and cardiotoxicity (See WARNINGS). Other reactions include: Cutaneous: Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely. Gastrointestinal:Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported. Local: If extravasation occurs during administration, severe local tissue necrosis, severe celluli-tis, thrombophlebitis, or painful induration can result. Acute Reactions: Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored. Read the Cerubidine (daunorubicin) Side Effects Center for a complete guide to possible side effectsLearn More »

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Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Principles: In order to eradicate the leukemic cells and induce a complete remission, a profound suppression of the bone marrow is usually required. Evaluation of both the peripheral blood and bone marrow is mandatory in the formulation of appropriate treatment plans. It is recommended that the dosage of Cerubidine (daunorubicin) 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: Serum Bilirubin Serum Creatinine Dose Reduction 1.2 to 3.0 mg% - 25% >3 mg% - 50% - >3 mg% 50% Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia: In Combination: For patients under age 60, Cerubidine (daunorubicin) 45 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. For patients 60 years of age and above, Cerubidine (daunorubicin) 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 (daunorubicin) 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 Combination: Cerubidine (daunorubicin) 25 mg/m2 IV on day 1 every week, vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission. In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the Cerubidine (daunorubicin) 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: In Combination: Cerubidine (daunorubicin) 45 mg/m2/day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m2/day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32. The contents of a vial should be reconstituted with 4 mL of Sterile Water for Injection and agitated gently until the material has completely dissolved. The sterile vial contents provide 20 mg of daunorubicin, with 5 mg of daunorubicin per mL. The desired dose is withdrawn into a syringe containing 10 mL to 15 mL of 0.9% Sodium Chloride Injection, USP and then injected into the tubing or sidearm in a rapidly flowing IV infusion of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Cerubidine (daunorubicin) should not be administered mixed with other drugs or heparin. Storage and Handling: Store unreconstituted powder at controlled room temperature, 15° to 30°C (59° to 86°F). The reconstituted solution is stable for 24 hours at room temperature and 48 hours under refrigeration. It should be protected from exposure to sunlight. Protect from light. Retain in carton until time of use. If Cerubidine (daunorubicin) 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.

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Use of Cerubidine (daunorubicin) in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Cerubidine (daunorubicin) should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or Cerubidine (daunorubicin) . Cyclophosphamide used concurrently with Cerubidine (daunorubicin) may also result in increased cardiotoxicity. Dosage reduction of Cerubidine (daunorubicin) may be required when used concurrently with other myelosup-pressive agents. Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity. Read the Cerubidine Drug Interactions Center for a complete guide to possible interactions Learn More »

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Cerubidine (daunorubicin) in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

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Cerubidine (daunorubicin) is contraindicated in patients who have shown a hypersensitivity to it.Last reviewed on RxList: 8/13/2008
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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Cerubine (daunorubicin HCl) for Injection, is available in butyl-rubber-stoppered vials, each containing 21.4 mg daunorubicin hydrochloride (equivalent to 20 mg of daunorubicin) and 100 mg of mannitol, as a sterile reddish lyophilized powder. When reconstituted with 4 mL of Sterile Water for Injection, USP, each mL contains 5 mg daunorubicin activity. NDC 55390-281-10 20 mg, single dose vials; carton of 10. REFERENCES 1. 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. 2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15,1985. 3. 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 Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115. 4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1:426-428, 1983. 5. 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. 6. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotox-ic and hazardous drugs. Am J Hosp Pharm 47:1033-1049, 1990. 7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), Am JHealth-Syst Pharm, 15:1669-1685, 1996. Manufactured by: Ben Venue Laboratories, Bedford, OH 44146. Manufactured for: Bedford Laboratories Inc, Bedford, OH 44146. June 2004. FDA Rev date: 12/13/00 Last reviewed on RxList: 8/13/2008
This monograph has been modified to include the generic and brand name in many instances.

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General: Therapy with Cerubidine (daunorubicin) requires close patient observation and frequent complete blood-count determinations. Cardiac, renal, and hepatic function should be evaluated prior to each course of treatment. Appropriate measures must be taken to control any systemic infection before beginning therapy with Cerubidine (daunorubicin) . Cerubidine (daunorubicin) may transiently impart a red coloration to the urine after administration, and patients should be advised to expect this. Laboratory Tests: Cerubidine (daunorubicin) may induce hyperuricemia secondary to rapid lysis of leukemic cells. As a precaution, allopurinol administration is usually begun prior to initiating antileukemic therapy. Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops. Carcinogenesis, Mutagenesis, Impairment of Fertility: Cerubidine (daunorubicin) , when injected subcutaneously into mice, causes fibrosarcomas to develop at the injection site. When administered to mice thrice weekly intraperitoneally, no carcinogenic effect was noted after 18 months of observation. In male rats administered Cerubidine (daunorubicin) thrice weekly for 6 months, at 1/70th the recommended human dose on a body surface area basis, peritoneal sarcomas were found at 18 months. A single IV dose of Cerubidine (daunorubicin) administered to rats at 1.6 fold the recommended human dose on a body surface area basis caused mammary adenocarcinomas to appear at 1 year. Cerubidine (daunorubicin) was mutagenic in vitro (Ames assay, V79 hamster cell assay), and clastogenic in vitro (CCRFCEM human lymphoblasts) and in vivo (SCE assay in mouse bone marrow) tests. In male dogs at a daily dose of 0.25 mg/kg administered intravenously, testicular atrophy was noted at autopsy. Histologic examination revealed total aplasia of the spermatocyte series in the seminiferous tubules with complete aspermatogenesis. Pregnancy Category D (See WARNINGS) Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Cerubidine (daunorubicin) , mothers should be advised to discontinue nursing during Cerubidine therapy. Elderly: See CLINICAL PHARMACOLOGY, Special Populations, Geriatric Patients. Pediatric Use: See CLINICAL PHARMACOLOGY, Special Populations, Pediatric Patients and WARNINGS, Cardiac Effects. Last reviewed on RxList: 8/13/2008
This monograph has been modified to include the generic and brand name in many instances.

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