Relapsing remitting multiple sclerosis

Active Ingredient: Natalizumab

Indication for Natalizumab

Population group: only adults (18 - 65 years old)

Natalizumab is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups:

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

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:

300 mg once every 4 weeks

Route of admnistration

Intravenous

Defined daily dose

300 - 300 mg

Dosage regimen

From 300 To 300 mg once every 28 day(s)

Detailed description

Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks.

Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months.

Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, double–blind studies. After 2 years continued therapy should be considered only following a reassessment of the potential for benefit and risk. Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving natalizumab and the presence of anti-John Cunningham virus (JCV) antibodies.

Active ingredient

Natalizumab

Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.

Read more about Natalizumab

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