Relapsing remitting multiple sclerosis

Active Ingredient: Fingolimod

Indication for Fingolimod

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)

Fingolimod is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

  • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.

or

  • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

For this indication, competent medicine agencies globally authorize below treatments:

0.25-0.50 mg once a day

Route of admnistration

Oral

Defined daily dose

0.25 - 0.5 mg

Dosage regimen

From 0.25 To 0.5 mg once every day

Detailed description

In adults, the recommended dose of fingolimod is 0.5 mg taken orally once daily.

In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight:

  • Paediatric patients with body weight ≤40 kg: 0.25 mg taken orally once daily.
  • Paediatric patients with body weight >40 kg: 0.5 mg taken orally once daily.

Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules.

When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.

The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for:

  • 1 day or more during the first 2 weeks of treatment.
  • more than 7 days during weeks 3 and 4 of treatment.
  • more than 2 weeks after one month of treatment.

If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.

Dosage considerations

Fingolimod can be taken with or without food.

Active ingredient

Fingolimod

Fingolimod is a sphingosine 1-phosphate receptor modulator. Fingolimod is metabolised by sphingosine kinase to the active metabolite fingolimod phosphate. By acting as a functional antagonist of S1P receptors on lymphocytes, fingolimod phosphate blocks the capacity of lymphocytes to egress from lymph nodes, causing a redistribution, rather than depletion, of lymphocytes.

Read more about Fingolimod

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