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Brand Name
Dacarbazine
View Brand InformationFDA approval date: August 08, 2001
Classification: Alkylating Drug
Form: Injection
What is Dacarbazine?
Dacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection is also indicated for Hodgkin’s disease as a second-line therapy when used in combination with other effective agents.
Approved To Treat
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Brand Information
Dacarbazine (Dacarbazine)
1DESCRIPTION
Dacarbazine for Injection, USP is a colorless to an ivory colored solid which is light sensitive. Each vial contains 200 mg of dacarbazine (the active ingredient), anhydrous citric acid and mannitol. Dacarbazine is reconstituted and administered intravenously (pH 3.0 to 4.0). Dacarbazine is an anticancer agent. Chemically, dacarbazine is 5-(3,3-Dimethyl-1-triazeno)imidazole-4-carboxamide with the following structural formula:
C
2CLINICAL PHARMACOLOGY
After intravenous administration of dacarbazine, the volume of distribution exceeds total body water content suggesting localization in some body tissue, probably the liver. Its disappearance from the plasma is biphasic with initial half-life of 19 minutes and a terminal half-life of 5 hours. In a patient with renal and hepatic dysfunctions, the half-lives were lengthened to 55 minutes and 7.2 hours. The average cumulative excretion of unchanged dacarbazine in the urine is 40% of the injected dose in 6 hours. Dacarbazine is subject to renal tubular secretion rather than glomerular filtration. At therapeutic concentrations dacarbazine is not appreciably bound to human plasma protein.
In man, dacarbazine is extensively degraded. Besides unchanged dacarbazine, 5-aminoimidazole-4-carboxamide (AIC) is a major metabolite of dacarbazine excreted in the urine. AIC is not derived endogenously but from the injected dacarbazine, because the administration of radioactive dacarbazine labeled with
Although the exact mechanism of action of dacarbazine is not known, three hypotheses have been offered:
1.inhibition of DNA synthesis by acting as a purine analog
2.action as an alkylating agent
3.interaction with SH groups
3INDICATIONS AND USAGE
Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.
4CONTRAINDICATIONS
Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
5WARNINGS
Hemopoietic depression is the most common toxicity with dacarbazine and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with dacarbazine.
Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when dacarbazine has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with dacarbazine alone.
Anaphylaxis can occur following the administration of dacarbazine.
6PRECAUTIONS
Hospitalization is not always necessary but adequate laboratory study capability must be available. Extravasation of the drug subcutaneously during intravenous administration may result in tissue damage and severe pain. Local pain, burning sensation, and irritation at the site of injection may be relieved by locally applied hot packs.
Carcinogenicity of dacarbazine was studied in rats and mice. Proliferative endocardial lesions, including fibrosarcomas and sarcomas were induced by dacarbazine in rats. In mice, administration of dacarbazine resulted in the induction of angiosarcomas of the spleen.
7ADVERSE REACTIONS
Symptoms of anorexia, nausea, and vomiting are the most frequently noted of all toxic reactions. Over 90% of patients are affected with the initial few doses. The vomiting lasts 1 to 12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with dacarbazine. Rarely, dacarbazine has caused diarrhea. Some helpful suggestions include restricting the patient’s oral intake of food for 4 to 6 hours prior to treatment. The rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days.
There are a number of minor toxicities that are infrequently noted. Patients have experienced an influenza-like syndrome of fever to 39°C, myalgias and malaise. These symptoms occur usually after large single doses, may last for several days, and they may occur with successive treatments.
Alopecia has been noted as has facial flushing and facial paresthesia. There have been few reports of significant liver or renal function test abnormalities in man. However, these abnormalities have been observed more frequently in animal studies.
Erythematous and urticarial rashes have been observed infrequently after administration of dacarbazine. Rarely, photosensitivity reactions may occur.
7.1OVERDOSAGE
Give supportive treatment and monitor blood cell counts.
8HOW SUPPLIED
Dacarbazine for Injection, USP is supplied as follows:
NDC 0143-9245-10 200 mg/vial of sterile dacarbazine in boxes of 10.
Store in a refrigerator 2° to 8°C (36° to 46°F).
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or
For Product Inquiry call 1-877-845-0689.
9REFERENCES
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 P. Jeffrey, Sc. D., Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street. Providence. Rhode Island 02902.
4.Clinical Oncological Society of Australia, Guidelines and recommendations for safe handling of antineoplastic agents. Med. J. Australia 1: 426-428, 1983.
5.Jones, R. B..
6.American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic drugs in hospitals. Am. J.Hosp. Pharm, 42: 131-137, 1985.
7.Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm, 53: 1669-1685, 1996.
10PRINCIPAL DISPLAY PANEL
NDC 0143-
NDC 0143-
