Ocrevus Ocrelizumab Injection

1. Indications and Usage
Relapsing Forms of Multiple Sclerosis (RMS):
Treatment of adult patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Primary Progressive Multiple Sclerosis (PPMS):
Treatment of adult patients with PPMS.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
Initial Dose: 300 mg administered as an intravenous infusion, followed by a second 300 mg infusion 2 weeks later.
Subsequent Doses: 600 mg administered as a single intravenous infusion every 6 months.
Administration:
Must be administered under the close supervision of an experienced healthcare professional.
Pre-medication with corticosteroids (e.g., methylprednisolone) and antihistamines (e.g., diphenhydramine) is required prior to each infusion to reduce the risk of infusion-related reactions.
3. Mechanism of Action
CD20 Targeting:
Ocrelizumab is a humanized IgG1 kappa monoclonal antibody that binds selectively to the CD20 antigen, a transmembrane protein located on the surface of pre-B and mature B lymphocytes.
B-Cell Depletion:
Binding of ocrelizumab to CD20 results in B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC) and complement-mediated cytotoxicity.
Pathogenesis:
B-cells are involved in the pathogenesis of MS through multiple mechanisms, including presentation of antigens to T-cells, production of pro-inflammatory cytokines, and regulation of T-cell responses.
4. Safety and Warnings
Infusion-Related Reactions (Boxed Warning):
Serious and life-threatening infusion-related reactions have occurred. Reactions typically occur during the first infusion or within 24 hours.
Infections:
Ocrelizumab may increase the risk of infections. Screen for Hepatitis B Virus (HBV) infection prior to initiation.
Malignancies:
The possibility of an increased risk of malignancies, including breast cancer, cannot be excluded.
Vaccinations:
Avoid administration of live vaccines during treatment.
5.Adverse Reactions
Most Common:
Infusion-related reactions, upper respiratory tract infections, headache, and skin infections.
6.Drug Interactions
Live Vaccines:
Avoid concurrent use with live vaccines.
Other Disease-Modifying Therapies:
Safety of switching from other disease-modifying therapies (DMTs) to ocrelizumab has not been fully established.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ocrelizumab.
Available Strength: 300 mg/10 mL concentrate for solution for infusion in a single-dose vial.
Appearance: Clear to slightly opalescent, colorless to slightly brownish-yellow liquid.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.