Xaluprine (previously Mercaptopurine Nova Laboratories)

mercaptopurine

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Xaluprine. 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 Xaluprine.

What is Xaluprine?

Xaluprine is a medicine that contains the active substance mercaptopurine. It is available as an oral suspension.

What is Xaluprine used for?

Xaluprine is used to treat children, adolescents and adults who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).

Because the number of patients with ALL is low, the disease is considered ‘rare’, and Xaluprine was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 April 2009.

The medicine can only be obtained with a prescription.

How is Xaluprine used?

Treatment with this medicine should be supervised by a healthcare professional experienced in treating patients with ALL.

The medicine is taken by mouth, using the syringe provided in the pack, once per day in the evening. The dose is determined for each patient mainly by body surface area and may be adjusted according to its effects in the blood. It can be taken with food (except dairy products) or on an empty stomach but this should be consistent from day to day. For more information, see the summary of product characteristics (also part of the EPAR).

How does Xaluprine work?

The active substance in this medicine, mercaptopurine has a similar chemical structure to purine, which is one of the fundamental chemicals that make up DNA. In the body, 6–mercaptopurine is converted within cells into a substance that interferes with the production of new DNA. This prevents the cells from dividing. In ALL, the lymphocytes multiply too quickly and live for too long. 6–Mercaptopurine prevents them from dividing and they eventually die, thereby slowing down the progression of the leukaemia. Medicines containing mercaptopurine in tablet form have been already used in the European Union (EU) for many years to treat patients with ALL.

How has Xaluprine been studied?

Because 6-mercaptopurine has been used for the treatment of ALL in the EU for a number of years in tablet form, the company presented results from the scientific literature of studies previously carried out with mercaptopurine tablets.

A study was also carried out to compare the bioavailability of Xaluprine, which is an oral suspension, with that of the tablet. The bioavailability study compared the way the two different forms of the same medicine are absorbed in the human body and the levels of the active substance they produce.

What benefit has Xaluprine shown during the studies?

The effectiveness of 6–mercaptopurine in slowing down the progression of ALL is already well known since it has been used for many years. The added benefit of Xaluprine is that, as an oral suspension, it will provide more accuracy in dosing and it is easier to be taken by children. The bioavailability study showed that Xaluprine is comparable to the tablets, but it works in a more predictable way and has a higher rate of absorption, for which reason the dose will need to be adjusted when a patient switches from one formulation to the other.

What is the risk associated with Xaluprine?

The most common side effects with mercaptopurine (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts) and thrombocytopenia (low blood platelet counts). For the full list of all side effects, see the package leaflet.

Xaluprine must not be used in people who are hypersensitive (allergic) to mercaptopurine or any of the other ingredients. It must also not be used at the same time as patients are having a yellow fever vaccination.

Why has Xaluprine been approved?

The CHMP noted that mercaptopurine is established as an important treatment for ALL and that the only authorised form in the EU is a 50-mg tablet, making it difficult to adjust the dose for smaller children. The Committee considered that an oral suspension allows more accurate dosing and is more convenient for children unable to swallow tablets. The CHMP also noted that the risks of using the medicine are well known.

The Committee concluded that the benefits of Xaluprine are greater than its risks and recommended that it be granted marketing authorisation.

Other information about Xaluprine

The European Commission granted a marketing authorisation valid throughout the European Union for Xaluprine on 9 March 2012.

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

Name Language First published Last updated
Xaluprine : EPAR - Summary for the public BG = bălgarski 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public ES = español 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public CS = čeština 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public DA = dansk 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public DE = Deutsch 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public ET = eesti keel 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public EL = elliniká 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public EN = English 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public FR = français 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public IT = italiano 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public LV = latviešu valoda 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public LT = lietuvių kalba 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public HU = magyar 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public MT = Malti 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public NL = Nederlands 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public PL = polski 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public PT = português 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public RO = română 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public SK = slovenčina 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public SL = slovenščina 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public FI = suomi 28/03/2012 27/09/2012
Xaluprine : EPAR - Summary for the public SV = svenska 28/03/2012 27/09/2012

This EPAR was last updated on 09/12/2014 .

Authorisation details

Product details

Product details for Xaluprine (previously Mercaptopurine Nova Laboratories)
NameXaluprine (previously Mercaptopurine Nova Laboratories)
Agency product numberEMEA/H/C/002022
Active substance

6-mercaptopurine monohydrate

International non-proprietary name (INN) or common name

mercaptopurine

Therapeutic area Leukemia, Lymphoid
Anatomical therapeutic chemical (ATC) code L01BB02
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Xaluprine (previously Mercaptopurine Nova Laboratories)
Marketing-authorisation holder

Nova Laboratories Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union09/03/2012

Contact address:

Nova Laboratories Ltd
Martin House
Gloucester Crescent
Wigston
Leicester LE18 4YL
United Kingdom

Product information

Product information

19/11/2014  Xaluprine (previously Mercaptopurine Nova Laboratories) -EMEA/H/C/002022 -PSUV/0008

Name Language First published Last updated
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014
Xaluprine : EPAR - Product Information SV = svenska 28/03/2012 09/12/2014

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
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012
Xaluprine : EPAR - All Authorised presentations SV = svenska 28/03/2012 27/09/2012

Pharmacotherapeutic group

Antineoplastic Agents

Therapeutic indication

Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.

Assessment History