Ocrelizumab instruction manual and marketing status

1. Generic name: Ocrelizumab, Ocrelizumab

Product name: Rocosine, OCREVUS

2. Indications:

Ocrelizumab (Ocrelizumab) is indicated for the treatment of the following diseases:

1. Relapsing forms of adult multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease,

2. Adult primary progressive multiple sclerosis.

3. Usage and dosage:

1. Recommended preoperative medication: Inject 100 mg methylprednisolone (or equivalent corticosteroid) intravenously about 30 minutes before each infusion of orrelizumab to reduce the frequency and severity of infusion reactions. Pre-administer an antihistamine (such as diphenhydramine) approximately 30-60 minutes before each infusion of ocrelizumab to further reduce the frequency and severity of infusion reactions. Also consider adding a fever-reducing medication (such as acetaminophen).

2. Recommended dose and dosage: Orelizumab is administered by intravenous infusion. After the infusion is completed, the patient should be observed for at least one hour.

Initial dose: 300 mg intravenous infusion, followed by a second 300 mg intravenous infusion two weeks later;

Subsequent dose: everysingle 600mg intravenous infusion for 6 months;

3. Delayed or missed dose: If a scheduled infusion of ocrelizumab is missed, the dose should be administered as soon as possible; do not wait until the next scheduled dose. Six months after a missed dose, reset the dosing schedule for the next consecutive dose. Ocrelizumab doses must be administered at least 5 months apart.

4. Adverse reactions:

In clinical studies of ocrelizumab, the most common adverse events were infusion reactions, including skin itching, rash, hives, flushing, throat and oral irritation, fever, fatigue, nausea, rapid heartbeat, headache, and dizziness.

5. Supply and storage:

Orelizumab injection is a preservative-free, sterile, clear or slightly opalescent colorless to light brown solution provided in a carton containing a 300mg/10mL (30mg/mL) single-dose vial. Store orelizumab vials in the outer carton at 2°C to 8°C (36°F to 46°F) away from light. Do not freeze or shake.

6. Taboo:

Orelizumab is contraindicated in the following patients:

1. ActiveHBV infection;

2. Have a history of life-threatening infusion reactions to OCREVUS.

7. Mechanism of action:

The exact mechanism by which ocrelizumab exerts its therapeutic effect in multiple sclerosis is unknown, but it is hypothesized to be related to binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Upon cell surface binding to B lymphocytes, orelizumab causes antibody-dependent cytolysis and complement-mediated lysis.

8. Listing situation:

1. Original drug:

United States: 2017-03-28, approved for listing (trade name: Ocrevus)

EU: 2018-01-08, approved for marketing (trade name: Ocrevus)

China: 2025-3-25, approved for listing(trade name: Rocosine/OCREVUS)

2. Generic drugs: None

Reference materials:https://www.ocrevus.com/