Dear Healthcare Professional Letter against off-label use of basiliximab (Simulect) in heart transplantations
09.09.2014
Novartis Croatia d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals to warn them against off-label use of basiliximab (Simulect) in heart transplantation.
Summary
The medicinal product Simulect is indicated for prevention of acute organ rejection in de novo allogeneic kidney transplantation. For other transplantation indications like heart transplantations, no randomised clinical trial to the sufficient extent comparing Simulect with other induction medicines or without induction therapy has ever been carried out. There was no evidence in heart transplantation investigations , whereas the rate of serious adverse events with Smulect as compared to other induction therapies was higher. The summary of Product Characteristics (SPC) and package leaflet will be revised to include the warning on absence of positive data on efficacy and safe use in the available clinical trials.
HALMED has not received any suspected adverse reaction report to basiliximab resulted from off-label use of the medicine. HALMED will continue to closely monitor the safe use of this medicine and will inform the public promptly about any new finding.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
