Nulojix

belatacept

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This is a summary of the European public assessment report (EPAR) for Nulojix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nulojix.

What is Nulojix?

Nulojix is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance belatacept.

What is Nulojix used for?

Nulojix is used in adults to prevent the body from rejecting a transplanted kidney.

It is used with corticosteroids and a mycophenolic acid (other medicines used to prevent organ rejection). An interleukin-2-receptor-antagonist medicine should also be used with Nulojix during the first week after the kidney transplant.

The medicine can only be obtained with a prescription.

How is Nulojix used?

Nulojix should only be prescribed and supervised by a doctor who has experience in the management of kidney-transplant patients.

Nulojix is given as an infusion into a vein over 30 minutes. Doses are calculated using the patient’s weight. In the initial phase it is given at a dose of 10 mg per kilogram body weight on day 1 (day of transplantation or the day before) and then again on days 5, 14 and 28. Further doses are given at the end of weeks 8 and 12.

After the initial phase, which lasts three months, Nulojix is given at a maintenance dose of 5 mg/kg every four weeks starting from the end of the week 16.

How does Nulojix work?

The active substance in Nulojix, belatacept, is an immunosuppressive medicine. It suppresses the activity of ‘T cells’, immune-system cells that can become involved in organ rejection.

T cells must be ‘activated’ before they work. This happens when certain molecules attach to receptors on the surface of the T cells. Belatacept has been designed to attach to two of these molecules called CD80 and CD86. This stops them activating the T cells, helping to prevent organ rejection.

How has Nulojix been studied?

In two main studies involving 1,209 patients who underwent a kidney transplant, Nulojix was compared with cyclosporine A (another medicine used to prevent organ rejection). Some patients were given intensive Nulojix treatment which involved a longer initial phase of six months. All patients were also treated with corticosteroids, mycophenolic acid, and basiliximab (an interleukin-2-receptor antagonist) during the first week after transplantation.

The main measures of effectiveness were the proportion of patients who survived with their transplanted kidneys intact and how well their kidneys functioned. The studies also looked at the number of organ rejections that occurred within one year of the transplant.

What benefit has Nulojix shown during the studies?

Nulojix was shown to improve patient and organ survival following kidney transplantation. In the first study, 97% of patients receiving Nulojix treatment survived with their kidneys intact (218 out of 226) compared with 93% of patients receiving cyclosporine A (206 out 221). Around 54% of patients receiving Nulojix and 78% of those receiving cyclosporine A had impaired kidney function. The proportion of patients who had an episode of organ rejection within one year was 17% for Nulojix and 7% for cyclosporine A.

In the second study, 89% (155 out of 175) of patients on Nulojix and 85% (157 out 184) of those on cyclosporine A survived with their kidneys intact. The proportion of patients with impaired kidney function was 77% in patients on Nulojix and 85% in patients on cyclosporine A. Around 18% of patients on Nulojix had an episode of organ rejection within one year compared with 14% of patients on cyclosporine A.

Intensive Nulojix treatment with a longer initial phase of six months produced similar results to treatment with a three-month initial phase.

What is the risk associated with Nulojix?

The most common serious side effects of Nulojix seen in more than 2% of patients are urinary-tract infection (infection of the structures that carry urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (a marker of kidney problems), pyelonephritis (kidney infection), diarrhoea, gastroenteritis (diarrhoea and vomiting), poor functioning of the transplanted kidney, leucopenia (low white blood cell counts), pneumonia (infection of the lungs), basal-cell carcinoma (a cancer), anaemia (low red-blood-cell counts) and dehydration. For the full list of all side effects reported with Nulojix, see the package leaflet.

Nulojix must not be used in patients who have not been exposed to the Epstein-Barr virus or in whom previous exposure is uncertain. This is because patients treated with Nulojix who have had no previous exposure to the virus are at higher risk of getting a type of cancer known as post-transplant lymphoproliferative disorder. For the full list of restrictions, see the package leaflet.

Why has Nulojix been approved?

The CHMP noted that Nulojix does not have the toxic effects on the kidneys seen with other immunosuppressive medicines commonly used in transplantation. Although the studies showed more acute rejections after one year of treatment with Nulojix compared with cyclosporine A, this did not lead to reduced patient and organ survival after three years. Overall, the benefits of Nulojix compared well with the comparator medicine. The CHMP therefore concluded that Nulojix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

A risk management plan has been developed to ensure that Nulojix is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nulojix, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Nulojix will include an alert card in each medicine’s pack to increase awareness of the benefits and risks with Nulojix.

Other information about Nulojix

The European Commission granted a marketing authorisation valid throughout the European Union for Nulojix on 17 June 2011.

For more information about treatment with Nulojix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Nulojix : EPAR - Summary for the public BG = bălgarski 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public ES = español 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public CS = čeština 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public DA = dansk 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public DE = Deutsch 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public ET = eesti keel 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public EL = elliniká 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public EN = English 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public FR = français 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public IT = italiano 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public LV = latviešu valoda 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public LT = lietuvių kalba 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public HU = magyar 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public MT = Malti 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public NL = Nederlands 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public PL = polski 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public PT = português 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public RO = română 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public SK = slovenčina 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public SL = slovenščina 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public FI = suomi 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public SV = svenska 07/07/2011 17/03/2016
Nulojix : EPAR - Summary for the public HR = Hrvatski 07/07/2011 17/03/2016

This EPAR was last updated on 28/06/2016 .

Authorisation details

Product details

Product details for Nulojix
NameNulojix
Agency product numberEMEA/H/C/002098
Active substance

belatacept

International non-proprietary name (INN) or common name

belatacept

Therapeutic area Kidney TransplantationGraft Rejection
Anatomical therapeutic chemical (ATC) code L04AA28

Publication details

Publication details for Nulojix
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision6
Date of issue of marketing authorisation valid throughout the European Union17/06/2011

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
United Kingdom

Product information

Product information

12/05/2016  Nulojix -EMEA/H/C/002098 -N/0033

Name Language First published Last updated
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016
Nulojix : EPAR - Product Information HR = Hrvatski 07/07/2011 28/06/2016

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
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  
Nulojix : EPAR - All Authorised presentations HR = Hrvatski 07/07/2011  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function). It is recommended to add an interleukin (IL)-2-receptor antagonist for induction therapy to this belatacept-based regimen.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nulojix : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 22/09/2011 28/06/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Nulojix : EPAR - Public assessment report HR = Hrvatski 07/07/2011  
CHMP summary of positive opinion for Nulojix HR = Hrvatski 15/04/2011  

Authorised

This medicine is approved for use in the European Union