Ofatumumab (2 brand names, 2 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, SOLUTION.
Routes of administration: INJECTION, SUBCUTANEOUS.
Brand Names
- ARZERRA
- KESIMPTA
Indications and Usage
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Contraindications
KESIMPTA is contraindicated in patients with: Active HBV infection [see Warnings and Precautions (5.1)]. History of hypersensitivity to ofatumumab or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2)].
Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Injection-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Reduction in Immunoglobulins [see Warnings and Precautions (5.3)] Liver Injury [see Warnings and Precautions (5.4)]
Mechanism of Action
The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ofatumumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.