"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
DOSAGE AND ADMINISTRATION
MaIignant Melanoma: The recommended dosage is 2 to 4.5mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals.2
An alternate recommended dosage is 250mg/square meter body surface/day I.V. for 5 days. Treatment may be repeated every 3 weeks.3,4
Hodgkin's Disease: The recommended dosage of DTIC-Dome (dacarbazine) in the treatment of Hodgkin's disease is 150mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks.5 An alternative recommended dosage is 375mg/square meterbody surface on day 1, in combination with other effective drugs, to be repeated every 15 days.6
DTlC-Dome (dacarbazine) 100mg/vial and 200mg/vial are reconstituted with 9.9 mL and 19.7 mL, respectively, of Sterile Water for Injection, U.S.P. The resulting solution contains 10mg/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 only intravenously.
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. U.S.P. or sodium chloride injection, U.S.P., 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.7-12 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
20 mL vials containing 200 mg of DTlC-Dome as sterile dacarbazine in boxes of 12. Store in a refrigerator 2°C to 8°C (36°F to 46°F).
2. Nathanson, L., et al.: Characteristics of prognosis and response to an imidazole carboxamide in malignant melanoma. Clinical Pharmacology and Therapeutics 12: 955–962, 1971.
3. Costanza, M.E., et al.: Therapy of malignant melanoma with an imidazole carboxamide and bischloroethyl nitrosourea. Cancer 30: 1457–1461, 1972.
4. Luce, J.K., et al.: Clinical trials with the antitumor agent 5-(3, 3-dimethyl-l-triazeno) imidazole-4-carboxamide (NSC-45388). Cancer Chemotherapy Reports 54: 119–124, 1970.
5. Bonadonna, G., et al.: Combined Chemotherapy (MOPP or ABVD)—radiotherapy approach in advanced Hodgkin's disease. Cancer Treatment Reports 61: 769–777, 1977.
6. Santoro, A., and Bonadonna, G.: Prolonged disease-free survival in MOPP-resistant Hodgkin's disease after treatment with adriamycin, bleomycin, vinblastine and dacarbazine (ABVD). Cancer Chemotherapy Pharmacol. 2: 101–105, 1979.
7. 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.
8. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15, 1985.
9. 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.
10. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents, Med. J. Australia 1: 426–428, 1983.
11. Jones, R.B., et al.: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca-A Cancer Journal for Clinicians Sept./Oct., 258–263, 1983.
12. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic drugs in hospitals. Am. J. Hosp. Pharm. 42: 131–137, 1985.
Manufactured by: Ben Venue Laboratories, Bedford, Ohio 44146. Distributed by: Bayer Pharmaceuticals Corporation, 400 Morgan Lane, West Haven, CT 06516 USA. FDA Rev date: 9/24/1998
Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Dtic-Dome Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.