Dacarbazine
Drug Details
- Generic Name
- Dacarbazine
- Brand Names
- Dacarbazine
- Application Number
- ANDA075812
- Sponsor
- Hikma Pharmaceuticals USA Inc.
- NDC Codes
- 3
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER, INJECTION, POWDER, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- DACARBAZINE
Indications and Usage
INDICATIONS AND USAGE 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.
Warnings
WARNINGS 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 antineoplastic 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.