Active Ingredient: Ravulizumab
Ravulizumab is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 40 kg and patient weight is ≤ 60 kg, intravenous, 2,400 milligrams ravulizumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 40 kg and patient weight is ≤ 60 kg, intravenous, 3,000 milligrams ravulizumab, once every 8 weeks.
Regimen B: In case that patient weight is ≥ 60 kg and patient weight is ≤ 100 kg, intravenous, 2,700 milligrams ravulizumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 60 kg and patient weight is ≤ 100 kg, intravenous, 3,300 milligrams ravulizumab, once every 8 weeks.
Regimen C: In case that patient weight is ≥ 100 kg, intravenous, 3,000 milligrams ravulizumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 100 kg, intravenous, 3,600 milligrams ravulizumab, once every 8 weeks.
The recommended dosing regimen consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. The doses to be administered are based on the patient’s body weight, as shown in Table 1. For adult patients (≥18 years of age), maintenance doses should be administered at a once every 8-week interval, starting 2 weeks after loading dose administration.
Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ravulizumab), but the subsequent dose should be administered according to the original schedule.
Table 1. Ravulizumab weight-based dosing regimen for adult patients with body weight greater than or equal to 40 kg:
| Body weight range (kg) | Loading dose (mg) | Maintenance dose (mg)* | Dosing interval |
|---|---|---|---|
| ≥40 to <60 | 2,400 | 3,000 | Every 8 weeks |
| ≥60 to <100 | 2,700 | 3,300 | Every 8 weeks |
| ≥100 | 3,000 | 3,600 | Every 8 weeks |
* First maintenance dose is administered 2 weeks after loading dose.
Treatment initiation instructions in patients who are complement-inhibitor treatment-naïve or switching treatment from eculizumab are shown in Table 2.
Table 2. Ravulizumab treatment initiation instructions:
| Population | Weight-based ravulizumab loading dose | Time of first ravulizumab weight- based maintenance dose |
|---|---|---|
| Not currently on ravulizumab or eculizumab treatment | At treatment start | 2 weeks after ravulizumab loading dose |
| Currently treated with eculizumab | At time of next scheduled eculizumab dose | 2 weeks after ravulizumab loading dose |
In adult patients with gMG, treatment with ravulizumab has only been studied in the setting of chronic administration.
Ravulizumab has not been studied in gMG patients with an MGFA Class V.
Plasma exchange (PE), plasmapheresis (PP) and intravenous immunoglobulin (IVIg) have been shown to reduce ravulizumab serum levels. A supplemental dose of ravulizumab is required in the setting of PE, PP or IVIg (Table 3).
Table 3. Supplemental dose of ravulizumab after PP, PE, or IVIg:
| Body weight range (kg) | Most recent ravulizumab dose (mg) | Supplemental dose (mg) following each PE or PP intervention | Supplemental dose (mg) following completion of an IVIg cycle |
|---|---|---|---|
| ≥40 to <60 | 2,400 | 1,200 | 600 |
| 3,000 | 1,500 | ||
| ≥60 to <100 | 2,700 | 1,500 | 600 |
| 3,300 | 1,800 | ||
| ≥100 | 3,000 | 1,500 | 600 |
| 3,600 | 1,800 | ||
| Timing of ravulizumab supplemental dose | Within 4 hours following each PE or PP intervention | Within 4 hours following completion of an IVIg cycle | |
Abbreviations: IVIg = intravenous immunoglobulin, kg = kilogram, PE = plasma exchange, PP = plasmapheresis
No dose adjustment is required for patients with gMG aged 65 years and over.
Ravulizumab should not be administered as an intravenous push or bolus injection.
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