NICE Recommends Mavenclad (Cladribine Tablets) for Highly Active Multiple Sclerosis (2)

- before initiating MAVENCLAD(R) in year 1, - before initiating MAVENCLAD(R) in year 2, - 2 and 6 months after start of treatment in each treatment year. If the lymphocyte count is below 500 cells/mmcubed, it should be actively monitored until values increase again.

Infections  Cladribine can reduce the body's immune defence and may increase the likelihood of infections. HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine.

The incidence of herpes zoster was increased in patients on cladribine. If lymphocyte counts drop below 200 cells/mmcubed, anti-herpes prophylaxis according to local standard practice should be considered during the time of grade 4 lymphopenia. Interruption or delay of MAVENCLAD(R) may be considered until proper resolution of the infection.

Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.

In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported. However, a baseline magnetic resonance imaging (MRI) should be performed before initiating MAVENCLAD(R) (usually within 3 months).

About Multiple Sclerosis   Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

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References:

1. National Institute for Health and Clinical Excellence (NICE). Final Appraisal Determination Cladribine Tablets for treating relapsing-remitting multiple sclerosis. 2017. Available at: https://www.nice.org.uk  [https://www.nice.org.uk/guidance/gid-tag392/documents/final-.... MAVENCLAD(R) Summary of Product Characteristics. August 2017. Availableat: !_https://www.medicines.org.uk_!  [!_https...]

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