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Information about Xaluprine

What is it and what is it used for?

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

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.

What are the benefits?

The Committee for Medicinal Products for Human Use (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.

What are main side effects?

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.

What studies have been done?

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.

Sources

EMA website for Xaluprine. Accessed on 27/10/17. Links available in External Resources

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).