Rapamune

sirolimus

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An overview of Rapamune and why it is authorised in the EU

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.

How is Rapamune used?

Rapamune treatment should be started by and remain under the guidance of a doctor who is a qualified specialist in transplantation. The medicine can only be obtained with a prescription.

Rapamune is available as an oral solution (1 mg/ml) and tablets (0.5, 1 and 2 mg).

To prevent organ rejection, the first dose is usually 6 mg given soon after the transplantation followed by 2 mg once a day. The doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient’s blood.

To treat patients with S-LAM, the dose of Rapamune is 2 mg daily and after 10 to 20 days the doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient’s blood.

For more information about using Rapamune, see the package leaflet or contact your doctor or pharmacist.

How does Rapamune work?

The active substance in Rapamune, sirolimus, is an immunosuppressant (a medicine that reduces the activity of the immune system). In the body, sirolimus attaches to a protein inside cells to make a ‘complex’. This complex then blocks another protein called ‘mammalian target of rapamycin’ (mTOR). Since mTOR is involved in the multiplication of activated T‑lymphocytes (white blood cells that are responsible for attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection.

In S-LAM, mTOR is overactive, causing excessive multiplication of cells that cause the disease. By blocking mTOR, Rapamune reduces the multiplication of these cells.

What benefits of Rapamune have been shown in studies?

Prevention of rejection

Rapamune was more effective than placebo (a dummy treatment) or azathioprine (another immunosuppressive medicine) in two main studies involving a total of 1,295 patients who were having a kidney transplant. All patients were also treated with ciclosporin and corticosteroids and were at low to moderate risk of rejection. The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months. In the first study, treatment failed in 19% (53 out of 284) of the patients adding Rapamune after 6 months, compared with 32% (52 out of 161) of those adding azathioprine. In the second study, treatment failed in 30% (68 out of 277) of the patients adding Rapamune, compared with 48% (62 out of 130) of those adding placebo.

Two additional studies looked at Rapamune as continuing treatment for up to 5 years in 765 patients who were able to stop ciclosporin after 2 to 3 months. Rapamune was effective in helping the new kidney to survive, with an improvement in how well it worked and an improvement in blood pressure when ciclosporin treatment was stopped.

Treatment of S-LAM

Rapamune was more effective than placebo in improving lung function in a study involving 81 patients with S-LAM. The main measure of effectiveness was a change of FEV1 (the maximum volume of air a person can breathe out in 1 second). FEV1 improved by an average of 1 ml per month in patients treated with Rapamune compared with a worsening by 12 ml per month in patients receiving placebo.

What are the risks associated with Rapamune?

The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showingaltered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne.

Patients allergic to peanut or soya must not take Rapamune oral solution because the solution contains soya oil.

For the full list of side effects and restrictions of Rapamune, see the package leaflet.

Why is Rapamune authorised in the EU?

The European Medicines Agency considered that Rapamune is effective for the prevention of rejection of a transplanted kidney in patients at low to moderate risk of rejection. The Agency noted that no medicinal product has been approved for the treatment of S-LAM and Rapamune’s effect on lung function is considered important. The Agency decided that Rapamune’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Rapamune?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rapamune have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Rapamune are continuously monitored. Side effects reported with Rapamune are carefully evaluated and any necessary action taken to protect patients.

Other information about Rapamune

Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001.

Name Language First published Last updated
Rapamune : EPAR - Medicine overview BG = bălgarski 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview ES = español 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview CS = čeština 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview DA = dansk 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview DE = Deutsch 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview ET = eesti keel 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview EL = elliniká 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview EN = English 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview FR = français 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview IT = italiano 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview LV = latviešu valoda 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview LT = lietuvių kalba 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview HU = magyar 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview MT = Malti 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview NL = Nederlands 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview PL = polski 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview PT = português 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview RO = română 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview SK = slovenčina 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview SL = slovenščina 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview FI = suomi 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview SV = svenska 2008-11-27 2018-09-13
Rapamune : EPAR - Medicine overview HR = Hrvatski 2008-11-27 2018-09-13
Name Language First published Last updated
Rapamune : EPAR - Risk-management-plan summary (English only) 2018-08-08  

This EPAR was last updated on 13/09/2018 .

Authorisation details

Product details

Product details for Rapamune
NameRapamune
Agency product numberEMEA/H/C/000273
Active substance

sirolimus

International non-proprietary name (INN) or common name

sirolimus

Therapeutic area Kidney TransplantationGraft Rejection
Anatomical therapeutic chemical (ATC) code L04AA10

Publication details

Publication details for Rapamune
Marketing-authorisation holder

Pfizer Limited

Revision37
Date of issue of marketing authorisation valid throughout the European Union13/03/2001

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

02/08/2018  Rapamune -EMEA/H/C/000273 -II/0164

Name Language First published Last updated
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08
Rapamune : EPAR - Product Information EN = English 2008-06-16 2018-08-08

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13
Rapamune : EPAR - All Authorised presentations EN = English 2008-09-11 2010-09-13

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Rapamune : EPAR - Procedural steps taken before authorisation EN = English 2009-06-16  
Rapamune : EPAR - Scientific Discussion EN = English 2006-08-08