Active Ingredient: Ravulizumab
Ravulizumab is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.
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, over the duration of 6 months.
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, over the duration of 6 months.
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, over the duration of 6 months.
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).
For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses are administered once every 8 weeks, starting 2 weeks after loading dose administration, as shown in Table 1.
Table 1. Ravulizumab weight-based dosing regimen:
| 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 |
* Maintenance dose is administered 2 weeks after loading dose.
There is no experience of concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion) use with ravulizumab. Administration of PE/PI may reduce ravulizumab serum levels.
PNH is a chronic disease and treatment with ravulizumab is recommended to continue for the patient’s lifetime, unless the discontinuation of ravulizumab is clinically indicated.
In aHUS, ravulizumab treatment to resolve thrombotic microangiopathy (TMA) manifestations should be for a minimum duration of 6 months, beyond which length of treatment needs to be considered for each patient individually. Patients who are at higher risk for TMA recurrence, as determined by the treating healthcare provider (or clinically indicated), may require chronic therapy.
This medicinal product must be administered through a 0.2 µm filter and should not be administered as an intravenous push or bolus injection.
For:
Regimen A: In case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, intravenous, 600 milligrams ravulizumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, intravenous, 600 milligrams ravulizumab, once every 4 weeks.
Regimen B: In case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, intravenous, 900 milligrams ravulizumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, intravenous, 2,100 milligrams ravulizumab, once every 8 weeks.
Regimen C: In case that patient weight is ≥ 30 kg and patient weight is ≤ 40 kg, intravenous, 1,200 milligrams ravulizumab, one dose, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 30 kg and patient weight is ≤ 40 kg, intravenous, 2,700 milligrams ravulizumab, once every 8 weeks.
Paediatric patients with body weight ≥40 kg are treated in accordance with the adult dosing recommendations. The weight-based doses and dosing intervals for paediatric patients ≥10 kg to <40 kg are shown in the table below.
For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses should be administered per weight-based dosing regimen shown in the following table, starting 2 weeks after loading dose administration.
Ravulizumab weight-based dosing regimen for paediatric patient with aHUS below 40 kg:
| Body weight range (kg) | Loading dose (mg) | Maintenance dose (mg)* | Dosing interval |
|---|---|---|---|
| ≥10 to <20 | 600 | 600 | Every 4 weeks |
| ≥20 to <30 | 900 | 2,100 | Every 8 weeks |
| ≥30 to <40 | 1,200 | 2,700 | Every 8 weeks |
* Maintenance dose is administered 2 weeks after loading dose.
Data to support safety and efficacy of ravulizumab for patients with body weight below 10 kg are limited. No recommendation on a posology can be made for patients below 10 kg body weight.
This medicinal product must be administered through a 0.2 µm filter and should not be administered as an intravenous push or bolus injection.
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