Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).
Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity (see section 5.1).
Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions. The first administration should be under clinical observation with appropriate medical support to manage severe reactions such as severe injection reactions, hypersensitivity reactions and/or anaphylactic reactions (see section 4.4).
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 (see section 4.3).
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 (see section 4.4).
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 (see sections 5.1 and 5.2), 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.
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 section 5.2).
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 section 5.2).
The safety and efficacy of subcutaneous ocrelizumab in children and adolescents less than 18 years of age has not yet been established. No data are available.
Ocrevus 920 mg solution for injection is not intended for intravenous administration and should always be administered as a subcutaneous injection by a healthcare professional.
It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient by the correct route, as prescribed.
Patients may start treatment using intravenous or subcutaneous ocrelizumab and patients currently receiving intravenous ocrelizumab may continue treatment with intravenous ocrelizumab or transition to Ocrevus 920 mg solution for injection.
The 920 mg dose should be administered as a subcutaneous injection in the abdomen in approximately 10 minutes. Use of a subcutaneous infusion set (e.g., winged/butterfly) is recommended. Any residual hold-up volume remaining in the subcutaneous infusion set should not be administered to the patient.
The injection site should be the abdomen, except for 5 cm around the navel. Injections should never be given into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars.
Ocrevus solution for injection should always be administered by a healthcare professional. For the initial dose, post-injection monitoring with access to appropriate medical support to manage severe reactions such as IRs, for at least one hour after injection is recommended. For subsequent doses, the need for post-injection monitoring is at the treating physician's discretion (see section 4.4).
For instructions on use and handling of the medicinal product prior to administration, see section 6.6.
There is limited clinical trial experience with doses higher than the approved dose of ocrelizumab. The highest dose tested to date in MS patients is 2000 mg, administered as two 1000 mg intravenous infusions separated by 2 weeks (Phase II dose finding study in RRMS) and 1200 mg, administered as a subcutaneous injection (Phase Ib dose finding study). The adverse reactions were consistent with the safety profile in the pivotal clinical studies.
There is no specific antidote in the event of an overdose; interrupt the injection immediately and observe the patient for IRs (see section 4.4).
Unopened vial:
2 years.
Prepared syringe:
Store in a refrigerator (2°C–8°C).
Do not freeze. Do not shake.
Keep the vials in the outer carton in order to protect from light.
If necessary, the unopened vial may be stored outside the refrigerator at temperatures ≤25 °C for up to 12 hours.
The vials can be removed and placed back into the refrigerator so that the total combined time out of the refrigerator of the unopened vial may not exceed 12 hours at ≤25°C.
For storage conditions after preparation of the syringe, see section 6.3.
23 mL of solution for injection in a vial (colourless Type I glass).
Pack size of 1 vial.
The medicinal product should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
The medicinal product is for single use only and should be prepared by a healthcare professional using aseptic technique.
No incompatibilities between this medicinal product and polypropylene (PP), polycarbonate (PC), polyethylene (PE), polyvinyl chloride (PVC), polyurethane (PUR) and stainless steel have been observed.
Preparation of the syringe:
● Prior to use, the vial should be removed from the refrigerator to allow the solution to come to room temperature.
● Withdraw the entire contents of Ocrevus solution for injection from the vial with a syringe and transfer needle (21G recommended).
● Remove the transfer needle and attach a subcutaneous infusion set (e.g., winged/butterfly) containing a 24–26G needle for injection. Use a subcutaneous infusion set with residual hold-up volume NOT exceeding 0.8 mL for administration.
● Prime the subcutaneous infusion line with the solution for injection to eliminate the air in the infusion line and stop before the fluid reaches the needle.
● Ensure the syringe contains exactly 23 mL of the solution after priming and expelling any excess volume from the syringe.
● Administer immediately to avoid needle clogging. Do not store the prepared syringe that has been attached to the already-primed subcutaneous infusion set.
If the dose is not administered immediately, refer to "Storage of the syringe" below.
Storage of the syringe:
● If the dose is not to be administered immediately, use aseptic technique to withdraw the entire contents of Ocrevus solution for injection from the vial into the syringe to account for the dose volume (23 mL) and priming volume for the subcutaneous infusion set. Replace the transfer needle with a syringe closing cap. Do not attach a subcutaneous infusion set for storage.
● If the syringe was stored in a refrigerator, allow the syringe to reach room temperature prior to administration.
Disposal:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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