Kesimpta Ofatumumab Injection

1. Indications and Usage
Relapsing Forms of Multiple Sclerosis: Indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
2. Dosage and Administration
Initiation Dose: The recommended dose is 20 mg administered subcutaneously at Weeks 0, 1, and 2. The first injection must be administered by a healthcare professional.
Maintenance Dose: Starting at Week 4, the recommended dose is 20 mg administered subcutaneously once every 4 weeks.
Administration: Subsequent injections can be self-administered after proper training. Preferred injection sites include the abdomen, thighs, or outer aspect of the upper arm.
Missed Dose: If a dose is missed, it should be administered as soon as possible, followed by resumption of the regular every-4-weeks schedule.
3. Mechanism of Action
CD20 Binding: Ocrelizumab is a recombinant humanized monoclonal antibody that selectively binds with high affinity to the CD20 antigen on pre-B and mature B lymphocytes.
B-Cell Depletion: The antibody depletes B cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), thereby reducing the autoimmune attack on the central nervous system.
4. Safety and Warnings
Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, can occur.
Serious Infections: Increased risk of infections, including upper respiratory tract infections and urinary tract infections.
Hepatitis B Reactivation: Reactivation of the Hepatitis B virus has been reported with B-cell depleting therapies.
Progressive Multifocal Leukoencephalopathy (PML): PML, a rare opportunistic viral infection of the brain, has been reported.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include nasopharyngitis, respiratory tract infection, pyrexia, headache, injection site reactions, and fatigue.
Clinical Research: Clinical trials have demonstrated that subcutaneous ocrelizumab significantly reduces the annualized relapse rate and delays disability progression in patients with RMS.
6. Drug Interactions
Live Vaccines: Live or live-attenuated vaccines should not be administered during treatment.
Immunosuppressants: Concomitant use with other immunosuppressive agents may increase the risk of infection.
7. Pharmaceutical Information
Composition: The active ingredient is ocrelizumab.
Appearance: It is a clear to slightly opalescent, colorless to pale yellow liquid.
Storage: Store at 2°C to 8°C in the original carton to protect from light. Do not freeze or shake.