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Dacarbazine
Overview
What is Dacarbazine?
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), citric acid monohydrate and mannitol. Dacarbazine for Injection, USP is reconstituted and administered intravenously (pH 3 to 4). Dacarbazine is an anticancer agent designated chemically as 5-(3,3-dimethyl-1-triazeno)-imidazole-4-carboxamide with the following structural formula:
What does Dacarbazine look like?
What are the available doses of Dacarbazine?
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What should I talk to my health care provider before I take Dacarbazine?
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How should I use Dacarbazine?
Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection, USP is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.
Malignant Melanoma:
An alternate recommended dosage is 250 mg/square meter body surface/day IV for 5 days. Treatment may be repeated every 3 weeks.
Hodgkin's Disease:
Dacarbazine for Injection 200 mg/vial is reconstituted with 19.7 mL of Sterile Water for Injection, USP. The resulting solution contains 10 mg/mL of dacarbazine having a pH of 3.0 to 4.0. The calculated dose of the resulting solution is drawn into a syringe and administered intravenously.
The reconstituted solution may be further diluted with 5% dextrose injection, USP or sodium chloride injection, USP and administered as an intravenous infusion.
After reconstitution and prior to use, the solution in the vial may be stored at 4°C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% dextrose injection, USP or sodium chloride injection, USP, the resulting solution may be stored at 4°C for up to 24 hours or at normal room conditions for up to 8 hours.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.
What interacts with Dacarbazine?
Dacarbazine for Injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
What are the warnings of Dacarbazine?
The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS).
Hemopoietic depression is the most common toxicity with Dacarbazine for Injection 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 for Injection.
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 for Injection has been administered concomitantly with other anti-neoplastic drugs: however, it has also been reported in some patients treated with Dacarbazine for Injection alone.
Anaphylaxis can occur following the administration of Dacarbazine for Injection.
What are the precautions of Dacarbazine?
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.
What are the side effects of Dacarbazine?
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 for Injection. Rarely, Dacarbazine for Injection 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 for Injection. Rarely, photosensitivity reactions may occur.
What should I look out for while using Dacarbazine?
Dacarbazine for Injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
Hemopoietic depression is the most common toxicity with Dacarbazine for Injection 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 for Injection.
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 for Injection has been administered concomitantly with other anti-neoplastic drugs: however, it has also been reported in some patients treated with Dacarbazine for Injection alone.
Anaphylaxis can occur following the administration of Dacarbazine for Injection.
What might happen if I take too much Dacarbazine?
Give supportive treatment and monitor blood cell counts.
How should I store and handle Dacarbazine?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used.Store in a refrigerator 2°C to 8°C (36°F to 46°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
After intravenous administration of Dacarbazine for Injection, 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 C in the imidazole portion of the molecule (dacarbazine-2-C) gives rise to AIC-2-C. Although the exact mechanism of action of Dacarbazine for Injection is not known, three hypotheses have been offered:
Non-Clinical Toxicology
Dacarbazine for Injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.Hemopoietic depression is the most common toxicity with Dacarbazine for Injection 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 for Injection.
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 for Injection has been administered concomitantly with other anti-neoplastic drugs: however, it has also been reported in some patients treated with Dacarbazine for Injection alone.
Anaphylaxis can occur following the administration of Dacarbazine for Injection.
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.
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 for Injection. Rarely, Dacarbazine for Injection 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 for Injection. Rarely, photosensitivity reactions may occur.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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