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Brand Name: DTIC-Dome Trade Name: dacarbazine
FDA Approved For: DTIC-Dome is indicated in the treatment of metastatic malignant melanoma. In addition, DTIC-Dome is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other effective agents. Pediatric Use: Not discussed in FDA's Product label.
Carcinogen: Carcinogenicity of DTIC was studied in rats and mice. Proliferative endocardial lesions, including fibrosarcomas and sarcomas were induced by DTIC in rats. In mice, administration of DTIC resulted in the induction of angiosarcomas of the spleen. Mutagen: Not discussed in FDA's Prouct label.
Manufacturer and/or Distributor: Bayer    

Adverse 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 1-12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with DTIC-Dome. Rarely, DTIC-Dome has caused diarrhea. Some helpful suggestions include restricting the patient's oral intake of food for 4-6 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 39C, 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 DTIC-Dome. Rarely, photosensitivity reactions may occur.


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