HHE Sponsored handbook: Cardioprotection in clinical | Página 6

6 HHE 2019 FIGURE 2 Dexrazoxane mechanism of action Iron ion Anthracycline Free radical How to administer Cardioxane® Reconstitution • Dissolve the contents of each vial in 25ml of water for injections • Shake gently to dissolve the vial contents • The resultant solution will have a pH of approximately 1.6 Dilution • Each vial should be diluted prior to infusion using either Ringer lactate or 0.16M sodium lactate (25ml or 100ml) • Cardioxane® is for single use only • Reconstituted and subsequently diluted Cardioxane® should be used immediately or within 4 hours if stored between 2–8ºC Dosage and administration • Cardioxane® is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10-times either the doxorubicin-equivalent dose or the epirubicin-equivalent dose • For persons with moderate to severe renal impairment, administer 50% of normal dose Disposal Please ensure the disposal of all unused medical product or material is carried out in accordance with local requirements. Dexrazoxane Cardioxane ® to the adverse reaction profi le may be unclear. Grade 3 and 4 toxicities are similar with or without dexrazoxane in patients with advanced breast cancer treated with anthracyclines. 16 Acute myeloid leukaemia (AML) has been reported uncommonly in adult breast cancer patients post-marketing. In paediatric patients, second primary malignancies, including AML and myelodysplastic syndrome, have been reported in clinical trials in both dexrazoxane and control groups. The long-term effect of dexrazoxane on secondary primary malignancies is not known. Meta-analysis of studies to evaluate late mortality after treatment indicates no signifi cant difference in deaths due to second primary malignancies between dexrazoxane and control groups. 13 After ten years of follow up, there was no signifi cant difference in the incidence of second malignant neoplasms in Cardioxane ® -treated children compared with those who received only anthracycline chemotherapy. 3 Resources Further country-specifi c information (France, Germany, Spain, Italy markets) [email protected] Cardioxane® further information www.clinigengroup.com/medicines-services/commercial- medicines/cardioxane/ Medical enquiry form www.clinigengroup.com/medical-enquiries/ Request Cardioxane® www.clinigengroup.com/direct/en-gb/products/detail/ dexrazoxane-hydrochloride