Usual Adult Dose for Stomach Cancer

After full hematologic recovery from any previous chemotherapy: 20 mg/m2 IV at 6- to 8-week intervals

Comments:

• Because of cumulative myelosuppression, patients should be reevaluated after each course of this drug and the dose reduced if the patient has experienced toxicity.
• Doses greater than 20 mg/m2 have not been shown to be more effective and are more toxic than lower doses.

• For disseminated adenocarcinoma of the stomach in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed
• For disseminated adenocarcinoma of the pancreas in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed

Usual Adult Dose for Gastric Cancer

After full hematologic recovery from any previous chemotherapy: 20 mg/m2 IV at 6- to 8-week intervals

Comments:

• Because of cumulative myelosuppression, patients should be reevaluated after each course of this drug and the dose reduced if the patient has experienced toxicity.
• Doses greater than 20 mg/m2 have not been shown to be more effective and are more toxic than lower doses.

• For disseminated adenocarcinoma of the stomach in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed
• For disseminated adenocarcinoma of the pancreas in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed

Renal Dose Adjustments

This drug should not be given to patients with a serum creatinine greater than 1.7 mg percent.

Liver Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested.

Dose Adjustments

DOSE ADJUSTMENTS:
NADIR AFTER THE PREVIOUS DOSE:

• Leukocytes greater than 4000/mm3 and platelets greater than 100,000/mm3: Give 100% of the prior dose.
• Leukocytes 3000 to 3999/mm3 and platelets 75,000 to 99,999/mm3: Give 100% of the prior dose.
• Leukocytes 2000 to 2999/mm3 and platelets 25,000 to 74,999/mm3: Give 70% of the prior dose.
• Leukocytes less than 2000 and platelets less than 25,000/mm3: Give 50% of the prior dose.

• No repeat dosage should be given until the leukocyte count has returned to 4000/mm3 and platelet count to 100,000/mm3.
• When this drug is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly.
• If the disease continues to progress after 2 courses of this drug, therapy should be stopped since chances of response are minimal.

Precautions

US BOXED WARNINGS:

• This drug should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents in facilities with adequate diagnostic and treatment equipment and trained personnel.
• Bone marrow suppression (e.g., thrombocytopenia, leukopenia) which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of this drug.
• Hemolytic uremic syndrome (HUS) a serious complication of chemotherapy consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported. The syndrome may occur at any time during therapy with this drug as a single agent or in combination with other cytotoxic drugs; however, most cases occur at doses 60 mg or greater. Blood product transfusion may exacerbate the symptoms associated with this syndrome. The incidence of the syndrome has not been defined.

• Hypersensitivity to the active component or any of the ingredients
• In patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes

Dialysis

Data not available

Other Comments

Administration advice:

• Inspect visually for particulate matter and discoloration prior to administration.
• Give this drug IV only and avoid extravasation. 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.
• The manufacturer product information should be consulted for more information.

• Avoid excessive heat (over 40C; 104F).
• Reconstituted with sterile water for injection to a concentration of 0.5 mg/mL is stable for 14 days refrigerated or 7 days at room temperature.
• This drug is stable in 0.9% sodium chloride injection for 12 hours.
• This drug is stable in sodium lactate injection for 24 hours.

• Platelet count
• White blood cell count
• Differential
• Hemoglobin