"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"...
MUTAMYCIN (mitomycin) is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. MUTAMYCIN (mitomycin) is not recommended to replace appropriate surgery and/or radiotherapy.
DOSAGE AND ADMINISTRATION
Each vial contains either mitomycin 5 mg and mannitol 10 mg, mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg. To administer, add Sterile Water for Injection, 10 mL, 40 mL, or 80 mL respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained.
After full hematological recovery (see guide to dosage adjustment) from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals:
20 mg/m2 intravenously as a single dose via a functioning intravenous catheter.
Because of cumulative myelosuppression, patients should be fully reevaluated after each course of MUTAMYCIN (mitomycin) , and the dose reduced if the patient has experienced any toxicities. Doses greater than 20 mg/m2 have not been shown to be more effective, and are more toxic than lower doses.
The following schedule is suggested as a guide to dosage adjustment:
|Nadir After Prior Dose||Percentage of Prior Dose to be Given|
|> 4000||> 100,000||100%|
|< 2000||< 25,000||50%|
No repeat dosage should be given until leukocyte count has returned to 4000/mm3 and platelet count to 100,000/mm3.
When MUTAMYCIN (mitomycin) is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly. If the disease continues to progress after two courses of MUTAMYCIN (mitomycin) , the drug should be stopped since chances of response are minimal.
- Unreconstituted MUTAMYCIN (mitomycin) stored at room temperature is stable for the lot life indicated on the package. Avoid excessive heat (over 40°C, 104°F).
- Reconstituted with Sterile Water for Injection to a concentration of 0.5 mg per mL, MUTAMYCIN (mitomycin) is stable for 14 days refrigerated or 7 days at room temperature.
- Diluted in various I.V. fluids at room temperature, to a concentration of 20 to 40 micrograms per mL:
- The combination of MUTAMYCIN (mitomycin) (5 mg to 15 mg) and heparin (1,000 units to 10,000 units) in 30 mL of 0.9% Sodium Chloride Injection is stable for 48 hours at room temperature.
|5% Dextrose Injection||3 hours|
|0.9% Sodium Chloride Injection||12 hours|
|Sodium Lactate Injection||24 hours|
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
MUTAMYCIN® (mitomycin for injection, USP)
NDC 0015-3001-20 – Each vial contains 5 mg mitomycin.
NDC 0015-3002-20 – Each vial contains 20 mg mitomycin.
NDC 0015-3059-20 – Each vial contains 40 mg mitomycin.
For information on package sizes available, refer to the current price schedule.
1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 253 (11):1590-1592.
3. National Study Commission on Cytotoxic Exposure–Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4. Clinical Oncological Society of Australia. Guidelines and Recommen- dations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.
5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA–A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.
6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033–1049.
7. Controlling Occupational Exposure to Hazardous Drugs (OSHA WORK PRACTICE GUIDELINES). Am J Health-Syst Pharm 1996;53:1669-1685.
Bristol-Myers Sqibb Company, Princeton, NJ 08543 U.S.A. Revised January 2000. FDA Rev date: 11/2/2000
Last reviewed on RxList: 10/24/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Mutamycin Information
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