Ocrevus Dosage/Direction for Use

Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
Premedication for infusion-related reactions: The following two premedications must be administered prior to each ocrelizumab infusion to reduce the frequency and severity of IRRs (see Precautions for additional steps to reduce IRRs): 100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each infusion; antihistamine approximately 30-60 minutes prior to each infusion.
In addition, premedication with an antipyretic (e.g., paracetamol) may also be considered approximately 30-60 minutes prior to each infusion.
Posology: Initial dose: 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 (see Table 5).
Subsequent doses: Subsequent doses of ocrelizumab thereafter are administered as a single 600 mg intravenous infusion every 6 months (see Table 5). The first subsequent dose of 600 mg 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.
Infusion adjustments in case of IRRs: Life-threatening IRRs: If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome, the infusion must be stopped immediately and the patient should receive appropriate treatment. The infusion must be permanently discontinued in these patients (see Contraindications).
Severe IRRs: If a patient experiences a severe IRR (such as dyspnea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately, and the patient should receive symptomatic treatment. The infusion should be restarted only after all symptoms have resolved. The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction. No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.
Mild to moderate IRRs: If a patient experiences a mild to moderate IRR (e.g., headache), the infusion rate should be reduced to half the rate at the onset of the event. This reduced rate should be maintained for at least 30 minutes. If tolerated, the infusion rate may then be increased according to the patient's initial infusion rate. No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.
Dose modifications during treatment: The previously mentioned examples of dose interruption and slowing (for mild/moderate and severe IRRs) will result in a change in the infusion rate and increase the total duration of the infusion, but not the total dose. No dose reductions are recommended.
Delayed or missed doses: If an infusion 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 (see Table 5).
Special populations: Adults over 55 years old and elderly population: Based on the limited data available (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions), 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 ocrelizumab every six months after they become 55 years and older.
Renal impairment: The safety and efficacy of ocrelizumab in patients with renal impairment has not been formally studied. Patients with mild renal impairment were included in clinical trials. There is no experience in patients with moderate and severe renal impairment. Ocrelizumab is a monoclonal antibody and cleared via catabolism (i.e. breakdown into peptides and amino acids), and a dose adjustment is not expected to be required for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The safety and efficacy of ocrelizumab in patients with hepatic impairment has not been formally studied. Patients with mild hepatic impairment were included in clinical trials. There is no experience in patients with moderate and severe hepatic impairment. Ocrelizumab is a monoclonal antibody and cleared via catabolism (rather than hepatic metabolism), and a dose adjustment is not expected to be required for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of ocrelizumab in children and adolescents aged 0 to 18 years has not yet been established. No data are available.
Method of administration: After dilution, treatment is administered as an intravenous infusion through a dedicated line. Infusions should not be administered as an intravenous push or bolus.
If patients did not experience a serious infusion-related reaction (IRR) with any previous ocrelizumab infusion, a shorter (2-hour) infusion can be administered for subsequent doses (Table 5, Option 2). (See Table 5.)

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Solutions for intravenous infusion are prepared by dilution of the concentrate into an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, to a final ocrelizumab concentration of approximately 1.2 mg/mL.
For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
Patients should be monitored during the infusion and for at least one hour after the completion of the infusion (see Precautions).