Active Ingredient: Nipocalimab
Nipocalimab is indicated as an add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 30 milligrams nipocalimab per kilogram of body weight, one dose, over the duration of 2 weeks. Afterwards, intravenous, 15 milligrams nipocalimab per kilogram of body weight, once every 2 weeks.
The recommended dose regimen is shown in Table 1.
Table 1. Recommended dose regimen:
| Population | Recommended dose (IV) | |
|---|---|---|
| Initial single dose | Maintenance dose (every 2 weeks) | |
| Adults and adolescents (12 years and older) | 30 mg/kg | 15 mg/kg |
If a scheduled infusion appointment is missed, the maintenance dose should be administered as soon as possible. Dosing should be resumed every 2 weeks thereafter.
No dose adjustment is required in patients aged 65 years and older.
This medicinal product should only be administered via intravenous infusion with in-line or add-on filtration. Do not administer as an intravenous push or bolus injection.
The initial single dose of medicinal product should be administered over approximately 30 minutes and the maintenance dose should be administered over approximately 15 minutes.
Patients should be monitored for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction. If an adverse reaction occurs during administration of treatment, the infusion may be slowed or discontinued.
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