Neuromyelitis optica spectrum disorder (NMOSD)

Active Ingredient: Satralizumab

Indication for Satralizumab

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Satralizumab is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.

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

120 mg at week 0, 2, 4 and every 4 weeks thereafter

For:

Dosage regimens

Subcutaneous, 120 milligrams satralizumab, once every 2 weeks, over the duration of 4 weeks. Afterwards, subcutaneous, 120 milligrams satralizumab, once every 4 weeks.

Detailed description

Satralizumab can be used as a monotherapy or in combination with oral corticosteroids (OCs), azathioprine (AZA) or mycophenolate mofetil (MMF). The posology in adolescent patients ≥12 years of age with body weight ≥40 kg and adult patients is the same.

Loading doses

The recommended loading dose is 120 mg subcutaneous (SC) injection every two weeks for the first three administrations (first dose at week 0, second dose at week 2 and third dose at week 4).

Maintenance doses

The recommended maintenance dose is 120 mg SC injection every four weeks.

Delayed or missed doses

If an injection is missed, for any reason other than increases in liver enzymes, it should be administered as described in the following table.

Recommended dosage for delayed or missed doses:

Last dose administeredRecommended dosage for delayed or missed doses
Missed a loading dose or less
than 8 weeks during the
maintenance period
The recommended dose should be administered as soon as
possible without waiting until the next planned dose.

Loading period:

If the second loading dose is delayed or missed, this dose should
be administered as soon as possible and the third and final
loading dose 2 weeks later.

If the third loading dose is delayed or missed, this dose should be
administered as soon as possible and the first maintenance dose 4
weeks later.

Maintenance period:

After the delayed or missed dose is administered, the dosing
schedule should be reset to every 4 weeks.
8 weeks to less than 12 weeksThe recommended dose should be administered at 0*, 2 weeks
and every 4 weeks thereafter.
12 weeks or longerThe recommended dose should be administered at 0*, 2, 4 weeks
and every 4 weeks thereafter.

* “0 weeks” refers to time of the first administration after the missed dose.

Dosage considerations

The recommended injection sites are the abdomen and thigh. Injection sites should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Active ingredient

Satralizumab

Satralizumab is a recombinant humanised immunoglobuline G2 (IgG2) monoclonal antibody (mAb) that binds to soluble and membrane-bound human IL-6 receptor (IL-6R) and thereby prevents IL-6 downstream signalling through these receptors.

Read more about Satralizumab

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