Rapamune
sirolimus
Table of contents
Overview
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.
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List item
Rapamune : EPAR - Medicine overview (PDF/102.44 KB)
First published: 27/11/2008
Last updated: 13/09/2018 -
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Rapamune : EPAR - Risk-management-plan summary (PDF/88.34 KB)
First published: 08/08/2018
Last updated: 08/06/2022
Authorisation details
Product details | |
---|---|
Name |
Rapamune
|
Agency product number |
EMEA/H/C/000273
|
Active substance |
Sirolimus
|
International non-proprietary name (INN) or common name |
sirolimus
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AA10
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
46
|
Date of issue of marketing authorisation valid throughout the European Union |
13/03/2001
|
Contact address |
Boulevard de la Plaine 17 |
Product information
22/07/2022 Rapamune - EMEA/H/C/000273 - IB/0189
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
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.