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NICE guidance - fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

Fingolimod is recommended as an option for the treatment of highly active relapsing-remitting multiple sclerosis in adults, only if:

  • they have an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon, and the manufacturer provides fingolimod with the discount agreed as part of the patient access scheme

  • Fingolimod is a sphingosine-1-phosphate receptor modulator that prevents lymphocytes from crossing the blood-brain barrier and causing damage to nerve cells in the brain and spinal cord

    • has a marketing authorisation as a single disease-modifying therapy in highly active relapsing-remitting multiple sclerosis for the following groups:

      • adults with high disease activity despite treatment with a beta interferon
        • these patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon
          • patients should have had at least one relapse in the previous year while on therapy, and have at least nine T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least one gadolinium-enhancing lesion.
          • a "non-responder" could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year

      • adults with rapidly evolving severe relapsing-remitting multiple sclerosis defined by two or more disabling relapses in 1 year, and with one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI

  • Adverse effects include:
    • most common adverse reactions to treatment with fingolimod include influenza virus infections, headaches, diarrhoea and elevated liver enzyme activity

    • summary of product characteristics (SPC) states that 'macular oedema with or without visual symptoms has been reported in 0.4% of patients treated with fingolimod 0.5 mg, occurring predominantly in the first 3-4 months of therapy'. An ophthalmological evaluation is therefore recommended at 3-4 months after treatment initiation

    • for full details of adverse reactions and contraindications, see the SPC

For full details then consult the full guideline (1).


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