Mitomycin

Chemical formula: C₁₅H₁₈N₄O₅  Molecular mass: 334.327 g/mol  PubChem compound: 5746

Interactions

Mitomycin interacts in the following cases:

Live virus vaccines

Immunisation with live virus vaccines (e.g. yellow fever vaccination) increases the risk of infection and other adverse reactions such as vaccinia gangrenosa and generalized vaccinia, in patients with reduced immunocompetence, such as during treatment with mitomycin. Therefore, live virus vaccines should not be administered during therapy. It is advised to use live virus vaccines with caution after stopping chemotherapy, and vaccinate not sooner than 3 months after the last dose of chemotherapy.

Vinca alkaloids, bleomycin

Combination with vinca alkaloids or bleomycin may reinforce pulmonary toxicity.

Doxorubicin

The cardiotoxicity of doxorubicin may be reinforced by mitomycin.

Fluorouracil, tamoxifen

An increased risk of haemolytic-uremic syndrome has been reported in patients receiving a concomitant administration of mitomycin and fluorouracil or tamoxifen.

Pyridoxine

In animal experiments, pyridoxine hydrochloride (vitamin B6) resulted in the loss of effect of mitomycin.

Pregnancy

There are no data from the use of mitomycin in pregnant women. Studies in animals have shown reproductive toxicity. Mitomycin has a mutagenic, teratogenic and carcinogenic effect and therefore may impair the development of an embryo. Mitomycin should not be used during pregnancy. In the case of a vital indication for the treatment of a pregnant patient a medical consultation should be carried out with respect to the risk of the harmful effects on the child, which are associated with the treatment.

Nursing mothers

It is suggested that mitomycin is excreted in breast milk. Due to its proven mutagenic, teratogenic and carcinogenic effects, mitomycin should not be administered during breast-feeding. Breast-feeding women must first discontinue breast-feeding before initiating treatment with mitomycin.

Carcinogenesis, mutagenesis and fertility

Fertility / Contraception in males and females

Female patients of a sexually mature age should take contraceptive measures during and up to 6 months after the end of chemotherapy or refrain from sexual intercourse.

Mitomycin has a genetically harmful effect. Men who are being treated with mitomycin are therefore advised not to father a child during treatment and up to 6 months thereafter and to seek advice on the preservation of sperm before the start of therapy due to the possibility of irreversible infertility caused by the therapy with mitomycin.

Effects on ability to drive and use machines

Even when used in accordance with instructions these medicinal products may cause nausea and vomiting and thereby reduce reaction times to such an extent that the ability to drive a motor vehicle or operate machinery is impaired. This applies even more in connection with alcohol.

Adverse reactions


Undesirable effects are listed below by system organ class and frequency. Frequencies below are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data)

Possible side-effects under systemic therapy

The most common side effects of mitomycin administered systemically are gastrointestinal symptoms like nausea and vomiting and bone marrow suppression with leukopenia and mostly dominant thrombocytopenia. This bone marrow suppression occurs in up to 65% of patients.

In up to 10% of patients serious organ toxicity in the form of interstitial pneumonia or nephrotoxicity must be expected.

Mitomycin is potentially hepatotoxic.

Blood and the lymphatic system disorders

Very common: Bone marrow suppression, leucopenia thrombocytopenia

Rare: Life-threatening infection, sepsis, haemolytic anaemia

Immune system disorders

Very rare: Severe allergic reaction

Cardiac disorders

Rare: Heart failure after previous therapy with anthracyclines

Respiratory, thoracic and mediastinal disorders

Common: Interstitial pneumonia, dyspnoe, cough, shortness of breath

Rare: Pulmonary hypertension, pulmonary veno-occlusive disease (PVOD)

Gastrointestinal disorders

Very common: Nausea, vomiting,

Uncommon: Mucositis, stomatitis, diarrhoea, anorexia

Hepato-biliary disorders

Rare: Liver dysfunction, increased transaminases, jaundice, veno-occlusive disease (VOD) of the liver

Skin and subcutaneous tissue disorders

Common: Exanthema, allergic skin rash, contact dermatitis, palmar-plantar erythema

Uncommon: Alopecia

Rare: Generalised exanthema

Renal and urinary disorders

Common: Renal dysfunction, increase in serum creatinine, glomerulopathy, Nephrotoxicity

Rare: Haemolytic uraemic syndrome(HUS) (commonly fatal), microangiopathic-haemolytic anaemia (MAHA syndrome)

General disorders and administration site conditions

Common: Following Extravasation: Cellulitis, tissue necrosis

Uncommon: Fever

Possible side-effects under intravesical therapy

Skin and subcutaneous tissue disorders

Common: Pruritus, allergic skin rash, contact dermatitis, Palmar plantar erythrodysaesthesia (PPE)

Rare: Generalised exanthema

Renal and urinary disorders

Common: Cystitis (possibly haemorrhagic), dysuria, nocturia, pollakisuria, hematuria, local irritation of the bladder wall

Very rare: necrotizing cystitis, allergic (eosinophilic) cystitis, stenosis of the efferent urinary tract, reduction in bladder capacity, bladder wall calcification, and bladder wall fibrosis.

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