Active Ingredient: Ocrelizumab
Ocrelizumab is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 300 milligrams ocrelizumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 300 milligrams ocrelizumab, one dose, over the duration of 6 months. Afterwards, intravenous, 600 milligrams ocrelizumab, once every 6 months.
The following two premedications must be administered prior to each ocrelizumab infusion to reduce the frequency and severity of IRRs (Table):
In addition, premedication with an antipyretic (e.g., paracetamol) may also be considered prior to each infusion.
Premedication prior to ocrelizumab intravenous infusion:
| Premedication | Timing |
| Methylprednisolone intravenous (or an equivalent) | approximately 30 minutes prior to ocrelizumab intravenous infusion |
| Antihistamine (e.g. diphenhydramine) | approximately 30-60 minutes prior to ocrelizumab intravenous infusion |
| Antipyretic (e.g. acetaminophen/paracetamol) may be considered | approximately 30-60 minutes prior to ocrelizumab intravenous infusion |
In adults, the initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.
In adults, subsequent doses of ocrelizumab thereafter are administered as a single 600 mg intravenous infusion every 6 months.
The first subsequent dose should be administered six months after the first infusion of the initial dose.
A minimum interval of 5 months should be maintained between each dose of ocrelizumab.
For:
Regimen A, in the case that patient age in years is ≥ 10 and patient weight is < 35 kg :
Intravenous, 150 milligrams ocrelizumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 150 milligrams ocrelizumab, one dose, over the duration of 6 months. Afterwards, intravenous, 300 milligrams ocrelizumab, once every 6 months.
Regimen B, in the case that patient age in years is ≥ 10 and patient weight is ≥ 35 kg :
Intravenous, 300 milligrams ocrelizumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 300 milligrams ocrelizumab, one dose, over the duration of 6 months. Afterwards, intravenous, 600 milligrams ocrelizumab, once every 6 months.
The following two premedications must be administered prior to each ocrelizumab infusion to reduce the frequency and severity of IRRs (Table):
In addition, premedication with an antipyretic (e.g., paracetamol) may also be considered prior to each infusion.
Premedication prior to ocrelizumab intravenous infusion:
| Premedication | Timing |
| Methylprednisolone intravenous (or an equivalent) | approximately 30 minutes prior to ocrelizumab intravenous infusion |
| Antihistamine (e.g. diphenhydramine) | approximately 30-60 minutes prior to ocrelizumab intravenous infusion |
| Antipyretic (e.g. acetaminophen/paracetamol) may be considered | approximately 30-60 minutes prior to ocrelizumab intravenous infusion |
In paediatric patients (aged 10 years and older), the initial dose is administered according to the patient's body weight:
In paediatric patients (aged 10 years and older), subsequent doses of ocrelizumab thereafter are administered as a single intravenous infusion every 6 months according to the patient's body weight:
Paediatric patients who start on a 300 mg dose and subsequently reach a stable body weight of 35 kg or more should be switched to the 600 mg dose.
The first subsequent dose should be administered six months after the first infusion of the initial dose.
A minimum interval of 5 months should be maintained between each dose of ocrelizumab.
For:
Subcutaneous, 920 milligrams ocrelizumab, once every 6 months.
The following two premedications are to be administered shortly before each ocrelizumab injection to reduce the risk of local and systemic injection reactions (IRs):
In addition, premedication with an antipyretic (e.g., paracetamol) may also be considered shortly before each administration.
The recommended dose is 920 mg administered every 6 months.
No division of the initial dose or subsequent doses into separate administrations is required.
A minimum interval of 5 months should be maintained between each dose of ocrelizumab.
If there are signs of a life-threatening IR, the injection should be stopped immediately, and the patient should receive appropriate treatment. Treatment must be permanently discontinued in these patients.
If a patient experiences a severe IR, the injection should be interrupted immediately, and the patient should receive symptomatic treatment. The injection should be completed only after all symptoms have resolved.
If an injection is missed, it should be administered as soon as possible; do not wait until the next planned dose. The treatment interval of 6 months (with a minimum of 5 months) should be maintained between doses.
Based on the limited data available for intravenous ocrelizumab, no posology adjustment is needed in patients over 55 years of age. Patients enrolled in the ongoing clinical trials continue to be dosed with 600 mg intravenous ocrelizumab every six months after they become older than 55 years old. The use of subcutaneous ocrelizumab was not studied in patients over 65 years of age.
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