A Dear Healthcare Professional letter to physicians concerning the prescribing of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets: post-marketing reports of pure red cell aplasia (PRCA)
13.06.2011
In collaboration with the Agency for Medicinal Products and Medical Devices, the marketing authorisation holder in the Republic of Croatia, Novartis Hrvatska d.o.o., sent A Dear Healthcare Professional letter to prescribing physicians with the latest information on the safety of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets.
Since PRCA (pure red cell aplasia) cases were recorded in patients treated with Micophenolate mophetil (MMF) in combination with other immunosuppressants, and since after oral use MMF metabolises to the micophenolic acid (active substance in the medicinal product Myfortic), the new safety information was added to the below chapters of the Summary of Product Characteristics for the medicinal product Myfortic:
4.4. Special warnings and precautions for use
4.8. Adverse reactions
Myfortic is indicated for the prophylaxis of acute transplant rejection in adult patients receiving an allogeneic renal transplant, administered in combination with cyclosporine and corticosteroids.
There have been no reports of PRCA in Croatia in patients treated with Myfortic. Several cases of PRCA in patients treated with Myfortic in combination with other immunosuppressants have been reported in other countries since 31 October 2009.
Prescribing physicians are hereby warned about the need for careful clinical supervision of all patients treated with Myfortic.
The text of the letter can be found below:
Notice to physicians about the prescribing of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets (in Croatian)
