Active Ingredient: Satralizumab
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:
For:
Subcutaneous, 120 milligrams satralizumab, once every 2 weeks, over the duration of 4 weeks. Afterwards, subcutaneous, 120 milligrams satralizumab, once every 4 weeks.
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.
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).
The recommended maintenance dose is 120 mg SC injection every four weeks.
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 administered | Recommended 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 weeks | The recommended dose should be administered at 0*, 2 weeks and every 4 weeks thereafter. |
| 12 weeks or longer | The 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.
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.
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