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MITOMYCIN is a brand name for Mitomycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mitomycin medac is indicated as intravesical administration for relapse prevention in adults with superficial urinary bladder carcinoma after transurethral resection.
Verbatim from this product's MHRA label. Tap a section to expand.
Mitomycin medac must be administered by physicians experienced in this therapy, only if strictly indicated. Mitomycin medac is only intended for intravesical use following reconstitution. Posology The content of one vial is required for one bladder instillation.
There are many intravesical mitomycin regimens, varying in the dose of mitomycin used, the frequency of instillation and the duration of therapy. Unless otherwise specified, the dose of mitomycin is 40 mg instilled into the bladder once weekly.
Regimens with instillations every 2 weeks, every month or 3 monthly can also be used. The specialist should decide on the optimum regimen, frequency and duration of therapy on an individual patient basis. Special populations Elderly Insufficient data from clinical studies are available concerning the use of mitomycin in patients ≥ 65 years of age.
Renal or hepatic impairment The medicinal product should be used with caution in patients with renal or hepatic impairment. Paediatric population The safety and efficacy of Mitomycin medac in children have not been established. No data are available.
Method of administration Mitomycin medac is only intended for intravesical instillation after being dissolved. It is advised to use this medicinal product at its optimal pH (urinary pH > 6) and to maintain the concentration of mitomycin by reducing fluid intake before, during and after instillation.
The bladder must be emptied before instillation with a catheter. Mitomycin is introduced into the bladder by means of a catheter and at low pressure. The length of individual instillation should be 1 – 2 hours. During this period the solution should have sufficient contact with the entire mucosal surface of the bladder.
Therefore the patient should be mobilised as much as possible. After 2 hours the patient should void the instilled solution, preferably in a sitting position. 6.
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 adverse reactions under intravesical therapy Adverse reactions may result either from the solution for intravesical instillation or after deep resection.
g. contact dermatitis, also in the form of palmar and plantar erythema), and cystitis. Skin and subcutaneous tissue disorders Common Allergic skin rash, contact dermatitis, palmar-plantar erythema, pruritus Rare Generalised exanthema Renal and urinary disorders Common Cystitis (possibly haemorrhagic), dysuria, nocturia, pollakiuria, haematuria, local irritation of the bladder wall Very rare or not known Necrotising cystitis, allergic (eosinophilic) cystitis, stenosis of the efferent urinary tract, reduced bladder capacity, bladder wall calcification, bladder wall fibrosis, bladder perforation Not known in case of extravasation: Bladder perforation, (fat) tissue necrosis of the surrounding area, vesical fistula, abscesses After intravesical administration, only minor amounts of mitomycin reach the systemic circulation.
Nevertheless, in very rare cases the following systemic undesirable effects have been reported: Possible systemic undesirable effects occurring very rarely following intravesical administration: Blood and lymphatic system disorders Leukocytopenia, thrombocytopenia Respiratory, thoracic and mediastinal disorders Interstitial lung disease Gastrointestinal disorders Nausea, vomiting, diarrhoea Hepatobiliary disorders Transaminases increased Skin and subcutaneous tissue disorders Alopecia Renal and urinary disorders Renal dysfunction General disorders and administration site conditions Fever Possible adverse reactions under systemic therapy The most common adverse reactions of mitomycin administered systemically are gastrointestinal symptoms like nausea and vomiting and bone marrow suppression with leukopenia and mostly dominant thrombocytopenia.
If cystitis does occur, symptomatic treatment with local anti-inflammatories and analgesics should be given. In most cases the mitomycin therapy can be continued, if necessary at a reduced dose. 8). Extravasation following intravesical administration Symptoms of extravasation after intravesical mitomycin administration might present straight after the application or weeks or months later.
It can be unclear if the extravasation occurred due to unnoticed perforation, a thinned muscularis propria or if the medicinal product was not administered correctly. First symptoms present as pelvic or abdominal pain that are refractory to simple analgesia.
(Fat) tissue necrosis in the surrounding area as a consequence of the extravasation was observed in most cases. 8). Therefore, physicians should consider the possibility that extravasation occurred if the patient complains about pelvic or abdominal pain to prevent serious consequences.
General hygiene for the patient It is recommended to wash hands and genital area after micturition. This applies especially to the first micturitions following mitomycin administration. Mitomycin is a mutagenic and potentially carcinogenic substance in humans.
Contact with the skin and mucous membranes is to be avoided. Bone marrow toxicity Due to the toxic effects of mitomycin on the bone marrow, other myelotoxic therapy modalities (in particular other cytostatics, radiation) must be administered with particular caution in order to minimise the risk of additive myelosuppression.
Long-term therapy may result in cumulative bone marrow toxicity. Bone marrow suppression may only manifest itself after a delay, being expressed most strongly after 4-6 weeks, accumulating after prolonged use and therefore often requiring an individual dose adjustment.
Occurrence of acute leukaemia (in some cases following preleukaemic phase) and myelodysplastic syndrome has been reported in patients concomitantly treated intravenously with mitomycin and other antineoplastic agents. In the case of pulmonary symptoms, which cannot be attributed to the underlying disease, therapy should be stopped immediately.
1 • Breastfeeding • Bladder wall perforation • Cystitis
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 lymphatic system disorders Very common Bone marrow suppression, leukopenia, thrombocytopenia Rare Haemolytic anaemia, thrombotic microangiopathy (TMA), incl.
thrombotic thrombocytopenic purpura (TTP) Not known Anaemia Infections and infestations Rare Life-threatening infection, sepsis Not known Infection 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, dyspnoea, cough, shortness of breath Rare Pulmonary hypertension, pulmonary veno- occlusive disease (PVOD) Gastrointestinal disorders Very common Nausea, vomiting Uncommon Mucositis, stomatitis, diarrhoea, anorexia Hepatobiliary disorders Rare Hepatic 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 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Pulmonary toxicity can be well treated with steroids. Therapy should be stopped immediately also if there are symptoms of haemolysis or indications of renal dysfunction (nephrotoxicity). The occurrence of a haemolytic-uraemic syndrome (HUS: irreversible renal failure, microangiopathic haemolytic anaemia [MAHA syndrome] and thrombocytopenia) is commonly fatal.
At intravenous doses > 30 mg of mitomycin/m² of body surface microangiopathic-haemolytic anaemia has been observed. Close monitoring of renal function is recommended. No cases of MAHA have been observed so far after intravesical use of mitomycin.
New findings suggest a therapeutic trial may be appropriate for the removal of immune complexes that seem to play a significant role in the onset of symptoms by means of immunoadsorption with staphylococcal protein A columns. Elderly Elderly patients often have reduced physiological function, bone marrow depression, which may be protracted, so administer mitomycin with special caution in this population while closely monitoring the patient’s condition.