Ofatumumab

KESIMPTA

What it isAnti-CD20 monoclonal antibody; relapsing multiple sclerosis.

Why this oneMonthly self-injection at home, unlike the infused anti-CD20 agents.

What limits itScreen for hepatitis B; infection risk and hypogammaglobulinemia with prolonged use. The same molecule is ARZERRA in CLL.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Relapsing forms of MS (CIS, relapsing-remitting, active secondary progressive)	Adults	20 mg SC at Weeks 0, 1, and 2	20 mg SC once monthly starting Week 4

Renal Undefined

Hepatic Undefined

Screen for HBV and obtain serum immunoglobulins, aminotransferases, alkaline phosphatase, bilirubin before first dose
Administer SC only (abdomen, thigh, or outer upper arm)
First injection under guidance of a healthcare professional; suitable for patient self-administration

Active HBV infection
History of hypersensitivity to ofatumumab or life-threatening injection-related reaction to KESIMPTA (including anaphylaxis and angioedema)

Serious/fatal infections; delay dosing during active infection
Injection-related and hypersensitivity reactions (incl. anaphylaxis, angioedema)
Reduction in immunoglobulins
Liver injury
Fetal risk based on animal data

Pregnancy May cause fetal harm/B-cell depletion (animal data); advise contraception during and 6 months after last dose

Lactation No human data; human IgG present in milk; potential for infant B-cell depletion unknown

NO BOXED WARNINGS

Principal riskInfection risk and hypogammaglobulinemia

Direct muscarinic antagonism0 / 4