- May 6, 2022
- Newsletter
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Brand Name :
Mutamycin, Mitomycin C
Synonyms :
mitomycin
Class :
Antibiotic, Anti-neoplastic
Dosage Forms & Strengths
Powder for Injection
5mg
20mg
40mg
Indicated for Pancreatic Cancer, Stomach cancer:
20mg/m2 intravenous every 6 to 8 weeks
10mg/m2 intravenous bolus on days 1 to 29. Do not exceed 20mg/dose
Dose Adjustments
Administer 50% if:
Platelet count is less than 25 x 10^3/mm³
Leukocyte count is less than 2000/mm³
Administer 70% if:
Platelet count is less than 25-74.999 x 10^3/mm³
Leukocyte count is less than 2000-2999/mm³
Administer Full dose if:
Platelet count is more than 75 x 10^3/mm³
Leukocyte count is more than 3000/mm³
Renal Impairment
CrCl<10ml/min: Decrease the dose by 25%
Serum creatinine>1.7mg/dL: Usage avoided
Safety and efficacy not established
Refer adult dosing
may decrease the diagnostic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the neutropenic effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of antineoplastic agents
may decrease the therapeutic effect of antineoplastic agents
may increase the toxic effect of antineoplastic agents
may increase the hypersensitivity reaction of immunosuppressants
may decrease the myelosuppressive effect of myelosuppressive agents
may decrease the therapeutic effect of immunosuppressants
poliovirus vaccine, live, trivalent
may decrease the therapeutic effect of immunosuppressants
poliovirus vaccine inactivated
may decrease the therapeutic effect of immunosuppressants
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect
measles mumps and rubella vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
smallpox (vaccinia) vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect
measles mumps and rubella vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
smallpox (vaccinia) vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the toxic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the toxic effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the toxic effect of immunosuppressants
may increase the myelosuppressive effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the myelosuppressive effect of myelosuppressive agents
may decrease the therapeutic effect of immunosuppressants
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
when both drugs are combined, there may be an increased risk or severity of adverse effects
when both the drugs are combined, the risk or severity of adverse effects increases
when both drugs are combined, there may be an increased risk or severity of adverse effects
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may reduce the therapeutic effect of typhoid Vaccine
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of bleeding when combined with mitomycin
it may enhance the risk of bleeding when combined with mitomycin
it may enhance the risk of bleeding when combined with mitomycin
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of side effects when combined with mitomycin
it may enhance the risk of side effects when combined with misoprostol
may decrease the serum concentration
may decrease the serum concentration
Actions and Spectrum:
Frequency defined
>10%
Myelosuppression (64%)
Fever (14%)
Hemolytic uremic syndrome (≤15%)
Nausea/vomiting (14%)
1-10%
Increased serum creatinine (2%)
Stomatitis (4%)
Mucous membrane toxicity (4%)
Frequency not defined
Pulmonary toxicity
Cystitis
Nephrotoxicity
Alopecia
Fatigue
Dyspnea
Interstitial fibrosis
Amenorrhea
Black box warning:
mitomycin has a black box warning, the most severe type of warning issued by the U.S. Food and Drug Administration (FDA). The black box warning for mitomycin highlights the potential for severe and sometimes fatal side effects associated with this medication.
The black box warning notes explicitly the following potential risks associated with mitomycin use:
Contraindications/caution:
Contraindications:
mitomycin should not be used in patients with a history of hypersensitivity to mitomycin or its components. Other contraindications include:
Caution:
In addition to contraindications, several cautions should be considered when using mitomycin. These include:
Pregnancy consideration: D
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
mitomycin is an antineoplastic (anti-cancer) drug that belongs to the class of drugs known as alkylating agents. It works by cross-linking DNA, which inhibits DNA synthesis and ultimately leads to cell death.
Pharmacodynamics:
The pharmacodynamics of mitomycin is complex and involves multiple mechanisms of action.
Pharmacokinetics:
Absorption
mitomycin is not orally bioavailable and must be administered intravenously.
Distribution
mitomycin has a high volume of distribution, ranging from 16-56 L/m², indicating that it is extensively distributed throughout the body. The drug is highly protein-bound (approximately 60-80%) to plasma proteins, primarily to albumin.
Metabolism
mitomycin is metabolized primarily by bioreductive activation in the liver to form active metabolites, including mitomycin radicals, which are responsible for its cytotoxic effects. The metabolism of mitomycin is mediated by several enzymes, including NADPH-cytochrome P450 reductase and DT-diaphorase.
Elimination and Excretion
