Mitomycin should be administered under
the supervision of a qualified physician experienced in the use
of cancer chemotherapeutic agents. Appropriate management of therapy
and complications is possible only when adequate diagnostic and
treatment facilities are readily available.
Bone wmarrow suppression, notably thrombocytopenia and leukopenia,
which may contribute to overwhelming infections in an already compromised
patient, is the most common and severe of the toxic effects of mitomycin
(See WARNINGS and ADVERSE
Hemolytic Uremic Syndrome (HUS) a
serious complication of chemotherapy, consisting primarily of microangiopathic
hemolytic anemia, thrombocytopenia, and irreversible renal failure,
has been reported in patients receiving systemic mitomycin. The
syndrome may occur at any time during systemic therapy with mitomycin
as a single agent or in combination with other cytotoxic drugs,
however, most cases occur at doses 60 mg of mitomycin. Blood
product transfusion may exacerbate the symptoms associated with
The incidence of the syndrome has
not been defined.
Mitomycin (also know as mitomycin-C) is an antibiotic isolated from the
broth of Streptomyces caespitosus which has been shown to have
antitumor activity. The compound is heat stable, has a high melting point,
and is freely soluble in organic solvents.
Mitomycin has the chemical name 6-Amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methyl-azirino[2,3:3,4]pyrrolo[1,2-a]indole-4,7-dione
carbamate (ester), the chemical formula is C15H18N4O5
and the molecular weight is 334.33.
Mitomycin for Injection is a sterile dry mixture of mitomycin and mannitol,
which when reconstituted with Sterile Water for Injection provides a solution
for intravenous administration.
Each vial contains mitomycin 20 mg and mannitol 40 mg. When constituted
as directed in the labeling the resultant pH is between 6.0 to 8.0.