Mitomycin

Registered South African indications:

• Breast carcinoma
• Gastric carcinoma
• Pancreatic carcinoma
• Bladder carcinoma
• Non-small cell lung carcinoma
• Head and neck squamous cell carcinoma
• Colorectal carcinoma

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy 
• Breastfeeding
• Acute infections
• Bladder wall perforation
• Coagulation disorders
• Cystitis
• Thrombocytopenia

Cautions

• Renal impairment
• Hepatic impairment
• Elderly
• Restrictive/obstructive disturbances to pulmonary ventilation
• Bone marrow depression
• Infections
• Poor general state of health
• Varicella

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

Breast carcinoma
Gastric carcinoma
Pancreatic carcinoma (additional agent required)
Bladder carcinoma
Non-small cell lung carcinoma (additional agent required)
Head and neck squamous cell carcinoma
Colorectal carcinoma  (additional agent required)

Consult specialist for dosages and regimens

Not established for use in children

Pregnancy 

• Contraindicated
• 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

Breastfeeding 

• Contraindicated 
• 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 breastfeeding. Breastfeeding women must first discontinue breastfeeding before initiating treatment with mitomycin

Renal Impairment 

• Caution; dose adjustment recommended

Hepatic Impairment 

• Caution; no information available 

Elderly 

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Cardiovascular Disorders

• Flushing
• Hypertension

Respiratory Disorders

• Interstitial lung disease
• Bronchospasm
• Pneumonitis

Gastrointestinal Disorders

• Diarrhoea
• Constipation
• Abdominal discomfort
• Stomatitis

Hepatobiliary Disorders

• Parenchymatous liver disorder
• Cholecystitis
• Jaundice

Genitourinary Disorders

• Acute renal failure
• Renal disorder
• Cystitis
• Haemturia
• Proteinuria
• Serious nephropathy
• Albuminuria

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Injection site phlebitis

Immune, Blood and Lymphatic System Disorders

• Bacterial, viral or fungal infections
• Sepsis 
• Septic shock
• Myelodysplastic syndrome
• Acute myeloid leukaemia
• Acute leukaemia
• Bone marrow depression
• Pancytopenia
• Neutropenia
• Granulocytopenia
• Febrile neutropenia
• Erythropenia
• Microangiopathic haemolytic anaemia
• Haemolytic uraemic syndrome
• Thrombotic thrombocytopenic purpura
• Eosinophilia
• Hypersensitivity
• Pyrexia

Others

• Chills
• Malaise
• Oedema
• Generalised weakness 
• Lethargy

• Other antineoplastic agents
• Irradiation
• Live vaccines

• Full blood count
• Renal function
• Hepatic function
• Pulmonary function

Mitomycin is an antitumour antibiotic that is activated in the tissues to an alkylating agent which disrupts deoxyribonucleic acid (DNA) in cancer cells by forming a complex with DNA and also acts by inhibiting division of cancer cells by interfering with the biosynthesis of DNA.

Injection (per vial) 2mg

• Mitomycin-C (Bodene) originator

Injection (per vial) 10mg

• Mitomycin-C (Bodene) originator