Basic Information
Rapamune
Regulatory Information
EMEA/H/C/000273
March 13, 2001
November 16, 2000
48
October 1, 2024
Company Information
Belgium
Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
Overview Summary
Rapamune is a medicine used to prevent the body from rejecting a newly transplanted kidney. It is used in adults who are at a low to moderate risk of rejection. It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months. Rapamune can then be used for continuing treatment with corticosteroids, but only if ciclosporin treatment can be stopped. Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function. S-LAM is a rare lung disease that causes worsening symptoms such as shortage of breath and occurs mainly in women who are at an age when they can have children. Rapamune contains the active substance sirolimus.