Mitomycin (Specialist drug)

The pinned product is ONE UK SPC, MITOCIN 20 MG powder for solution for injection/infusion or intravesical use, whose section 4.1 covers both uses the page names: intravenous palliative tumour therapy (gastric, breast; in combination non-small cell bronchial and pancreatic carcinoma) and intravesical relapse prevention in superficial urinary bladder carcinoma after transurethral resection. NOT COVERED by this SPC, so no dose is given: TOPICAL/ophthalmic mitomycin, and the pyelocalyceal gel (Jelmyto, named in the page's brandNames). Other mitomycin products may carry different regimens; this card is for the Mitocin 20 mg SPC only. STRENGTH (section 2): 20 mg mitomycin per vial; 0.5 mg/ml after reconstitution with 40 ml water for injections (injection/infusion), 1 mg/ml after reconstitution with 20 ml solvent (intravesical). SPECIALIST USE (section 4.2): 'Mitomycin should only be used by doctors experienced in this therapy if there is a strict indication and with continual monitoring of the haematological parameters.' The dose line applies 'Unless otherwise prescribed'. INTRAVENOUS (section 4.2): 'In cytostatic monochemotherapy mitomycin is usually administered intravenously as a bolus injection.' 'In combination therapy the dosage is considerably lower. Because of the risk of additive myelotoxicity, proven treatment protocols may not be deviated from without a specific reason.' 'It is essential that the injection is administered intravenous. If the medicinal product is injected perivasally, extensive necrosis occurs in the area concerned.' For infusion the reconstituted solution 'can be diluted with isotonic sodium chloride infusion solution down to a concentration of 20 - 40 micrograms of mitomycin/ml'; one vial is dissolved in 40 ml of water for injections. Section 4.4 injection advice: always inject into large veins in the arms; do not inject directly but into the tube of a good and securely running infusion. INTRAVESICAL (section 4.2): 'In the case of intravesical administration the urine pH should be higher than pH 6.' The intravesical solution is the contents of 1-2 vials dissolved in 20-40 ml of water for injections or sodium chloride (0.9%) solution. Section 4.4: symptoms of extravasation after intravesical administration may present straight after the application or weeks or months later, first as pelvic or abdominal pain refractory to simple analgesia. NO MAXIMUM DOSE is printed in this SPC, so none is given. The only high-dose figure (section 4.4: 'At doses of > 30 mg of mitomycin/m2 of body surface microangiopathic- haemolytic anaemia has been observed') is a toxicity warning, not a stated dose limit. DOSE REDUCTION (section 4.2): 'The dose must be reduced in patients who have undergone extensive previous cytostatic therapy, in case of myelosuppression or in elderly patients.' No reduction figure is given. ELDERLY: 'Insufficient data from clinical studies are available concerning the use of mitomycin in patients >= 65 years of age'; section 4.4 advises special caution with close monitoring. PAEDIATRIC: 'The safety and efficacy of mitomycin in children have not been established.' No paediatric dose. HANDLING (section 4.4): 'Mitomycin is a mutagenic and potentially carcinogenic substance in humans. Contact with the skin and mucous membranes is to be avoided.' SOURCE COMPLETENESS: sections 4.1-4.6 are complete as retrieved; section 4.8 is cut off only in its closing paragraph (the reaction lists are complete). The text came from a PDF and has odd spacing in places.