Active Ingredient: Rozanolixizumab
Rozanolixizumab is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients 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:
Regimen A: In case that patient weight is ≥ 35 kg and patient weight is ≤ 50 kg, oral, 280 milligrams rozanolixizumab, once weekly, over the duration of 6 weeks.
Regimen B: In case that patient weight is ≥ 50 kg and patient weight is ≤ 70 kg, oral, 420 milligrams rozanolixizumab, once weekly, over the duration of 6 weeks.
Regimen C: In case that patient weight is ≥ 70 kg and patient weight is ≤ 100 kg, oral, 560 milligrams rozanolixizumab, once weekly, over the duration of 6 weeks.
Regimen D: In case that patient weight is ≥ 100 kg, oral, 840 milligrams rozanolixizumab, once weekly, over the duration of 6 weeks.
A treatment cycle consists of 1 dose per week for 6 weeks.
The following table indicates the recommended total weekly dose of rozanolixizumab according to the patient’s body weight:
| Body weight | ≥35 to <50 kg | ≥50 to <70 kg | ≥70 to <100 kg | ≥100 kg |
|---|---|---|---|---|
| Weekly dose (mg) | 280 mg | 420 mg | 560 mg | 840 mg |
Subsequent treatment cycles should be administered according to clinical evaluation. The frequency of treatment cycles may vary by patient. In the clinical development program, most patients had treatment-free intervals of 4-13 weeks between cycles. From cycle to cycle approximately 10% of patients had a treatment-free interval of less than 4 weeks.
If a scheduled infusion is missed, rozanolixizumab may be administered up to 4 days after the scheduled time point. Thereafter, the original dosing schedule should be resumed until the treatment cycle is completed.
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