OCREVUS

Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions. Ocrevus subcutaneous (SC) formulation is not intended for intravenous administration. 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 Ocrevus SC or intravenous ocrelizumab and patients currently receiving intravenous ocrelizumab may continue treatment with intravenous ocrelizumab or transition to Ocrevus SC. , paracetamol) may also be considered shortly before each administration.

Posology The recommended dose of Ocrevus SC is 920 mg administered every 6 months in a single subcutaneous injection. A minimum interval of 5 months should be maintained between each dose of ocrelizumab. Delayed or Missed Doses If an injection is missed, it should be administered as soon as possible.

The treatment interval of 6 months (with a minimum of 5 months) should be maintained between doses. 2), no posology adjustment is needed in patients over 55 years of age. There are no data available in patients over 65 years of age. 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. e. 2). 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. 2). 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 The 920 mg dose (23 mL) should be administered as a subcutaneous injection in the abdomen in approximately 10 minutes. , winged/butterfly) is recommended. The injection site should be the abdomen, except for 2 inches (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 SC should always be administered under the supervision of a healthcare professional. For the initial dose, post-injection monitoring with access to appropriate medical support to manage severe reactions such as injection reactions, for at least one hour after injection is recommended.

Summary of the safety profile The safety profile of ocrelizumab is based on data in patients with RMS and PPMS who were administered ocrelizumab intravenously or subcutaneously. 4). A total of 2,376 patients were included in the controlled period of the pivotal clinical trials; of these patients, 1,852 entered the OLE phase.

All patients switched to ocrelizumab treatment during the OLE phase. 1,155 patients completed the OLE phase, resulting in approximately 10 years of continuous ocrelizumab treatment (15,515 patient years of exposure) across the controlled period and OLE phase.

The overall safety profile observed during the controlled period and OLE phase remains consistent with that observed during the controlled period. The safety of Ocrevus SC has been evaluated in 312 patients from MS clinical studies, 181 patients from OCARINA II and 118 patients from OCARINA I, who were given at least one dose of Ocrevus SC 920 mg.

The safety observed for Ocrevus SC was consistent with the known safety profile of intravenous ocrelizumab, except for the very common adverse reaction of IRs, which are related to the subcutaneous route of administration. Tabulated list of adverse drug reactions Adverse reactions reported in the controlled period of the pivotal clinical trials with ocrelizumab and derived from spontaneous reporting are listed below in Table 2.

The adverse reactions are listed by MedDRA system organ class and categories of frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

Within each System Organ Class, the adverse reactions are presented in order of decreasing frequency. Table 2 Adverse reactions MedDRA System Organ Class (SOC) Very common Common Not Known Infections and infestations Upper respiratory tract infection, nasopharyngitis, influenza Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis Blood and lymphatic system disorders Neutropenia Late onset of neutropenia3 Respiratory, thoracic and mediastinal disorders Cough, catarrh Investigations Blood immunoglobulin M decreased Blood immunoglobulin G decreased Injury, poisoning and procedural complications Infusion-related reactions1, injection reaction2 1 Observed only in the pooled intravenous ocrelizumab dataset 2 Observed in a study outside of the pooled intravenous ocrelizumab dataset (associated with subcutaneous administration).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Injection Reactions (IRs) Treatment with subcutaneous ocrelizumab is associated with IRs, which may be related to cytokine release and/or other chemical mediators.

Serious infusion-related reactions (IRRs), some requiring hospitalisation, have been reported with the use of intravenous ocrelizumab (for further information, see the product information of Ocrevus 300 mg concentrate for solution for infusion).

Physicians should alert patients that IRs can occur during or within 24 hours of administration. Symptoms of IRs have been more frequently reported with the first injection. IRs can be local IRs or systemic IRs. Common symptoms of local IRs at the injection site include erythema, pain, swelling and pruritus.

8). 2). Patients should be observed for at least one hour after the initial dose of the medicinal product for any symptom of severe IR. For subsequent doses, the need for post-injection monitoring is at the treating physician’s discretion.

Appropriate resources for the management of severe IRs, hypersensitivity reactions and/or anaphylactic reactions should be available for the initial dose of the medicinal product. IRs can be managed with symptomatic treatment, should they occur.

If there are signs of a life-threatening IR, the injection should be stopped immediately, and the patient should receive appropriate treatment. Ocrelizumab 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. Hypersensitivity reactions A hypersensitivity reaction may present during any administration, although typically would not present during the first administration.

1. 4). 4). 4).