Lysosafe
LYSOSAFE: a free service for testing plasma levels of Mitotane
In 2004, HRA Pharma was granted with a European Marketing Authorisation for its orphan drug Lysodren (mitotane 500mg tablets) indicated in the symptomatic treatment of advanced (unresectable, metastatic or relapsed) Adrenal Cortical Carcinoma. HRA Pharma then launched LYSOSAFE, a free service associated with the use of mitotane in order to optimize the safety and efficacy of treatment.
Scientific research has not established yet a correlation between the patient's mitotane daily dose and mitotane plasma levels; furthermore it is known that mitotane has a narrow therapeutic window (14-20mg/l). Therefore frequent monitoring of mitotane plasma levels is highly recommended during treatment with mitotane.
Lysosafe will enable prescribers of Lysodren to monitor mitotane plasma levels of every treated patient in order to:
- safely reach the therapeutic window (14 - 20 mg/l).
- adapt the patient's daily dose even in specific patient populations (elderly, paediatric or with renal or liver impairment).
- reduce risk of adverse events.
Lysosafe includes the shipping of the samples to a unique centralised bioanalytical center, the testing and the sending of the results within 10 days by fax, e-mail and by regular mail.
Lysosafe is available to all hospitals in Europe using the European approved Lysodren (mitotane 500mg tablets). It is also offered to developing countries whether or not they are using HRA mitotane product. After 2 years, Lysosafe is now used in more than 20 countries and already 500 patients have been monitored. This reprensents a key achievement in optimising the management of Adrenal Cortical Carcinoma.