MHRA/CHM ADVICE: MITOMYCIN-C KYOWA ® 40 MG RESTRICTED
TO INTRAVESICAL ADMINISTRATION ONLY FOR TREATMENT OF
SUPERFICIAL BLADDER CANCER (SEPTEMBER 2019)
Sub-visible particles, at levels above specification limits,
have been observed after reconstitution of Mitomycin-C
Kyowa ® 40 mg; healthcare professionals are advised that
its use has been restricted to the treatment of superficial
bladder cancer via the intravesical route only.
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→Appendix 1: mitomycin
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GENERAL SIDE-EFFECTS
▶Common or very common Bone marrow disorders. cough.
cystitis. haemorrhage. leucopenia. malaise. nausea.
respiratory disorders. skin reactions. thrombocytopenia.
vomiting
▶Uncommon Alopecia. appetite decreased. diarrhoea. fever
▶Rare or very rare Hepatic disorders. increased risk of
infection. renal disorder. sepsis
▶Frequency not known Anaemia. asthenia. chills.
constipation. eosinophilia. erythropenia. flushing.
hypertension. lethargy. neutropenia. oedema. weight
decreased
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With intravenous use Dyspnoea. extravasation necrosis.
glomerulonephropathy. nephropathy. renal impairment
▶With intravesical use Hypersensitivity. urinary disorders.
urinary tract discomfort
▶Uncommon
▶With intravenous use Mucositis. oral disorders
▶Rare or very rare
▶With intravenous use Haemolytic anaemia. heart failure.
pulmonary hypertension. sinusoidal obstruction
syndrome
▶With intravesical use Acute kidney injury. bladder disorders.
urinary tract stenosis
▶Frequency not known
▶With intravenous use Abdominal discomfort. cholecystitis.
injection site necrosis. neoplasms. shock. urine
abnormalities. vascular pain
▶With intravesical use Pain. penile necrosis. proteinuria.
pulmonary oedema. ulcer
SIDE-EFFECTS, FURTHER INFORMATION Mitomycin is
usually administered at 6-weekly intervals because it
causes delayed bone-marrow toxicity. Prolonged use may
result in a cumulative effect.
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Contraceptive advice
required, see Pregnancy and reproductive function in
Cytotoxic drugs p. 938.
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Avoid (teratogenic in animal studies). See
also Pregnancy and reproductive function in Cytotoxic drugs
p. 938.
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Discontinue breast-feeding.
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