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
MUTAMYCIN (mitomycin) should be given intravenously only, using care to avoid extrava-sation of the compound. If extravasation occurs, cellulitis, ulceration, and slough may result.
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
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
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
- 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
|0.9% Sodium Chloride Injection
|Sodium Lactate Injection
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
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;
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