Ofatumumab
KESIMPTA
Pronunciation: o-fa-TOOM-yoo-mab (KEE-simp-ta)
“Offer two moo mabs (to) Key symptoms”
Antibody targeting CD20 marker on B-cells for multiple sclerosis
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
- Relapsing forms of multiple sclerosis (2009)
FDA label
Read the full label on DailyMed ↗
| 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
Instructions
- 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
Available strengths
- inj 20 mg/.4 mL
Contraindications
- Active HBV infection
- History of hypersensitivity to ofatumumab or life-threatening injection-related reaction to KESIMPTA (including anaphylaxis and angioedema)
Cautions
- 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
Adverse reactions
- Upper respiratory tract infection
- Headache
- Injection-related (systemic) reactions
- Injection-site (local) reactions
- Urinary tract infection
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
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 20 mg/.4 mL | inj | per unit | — | $24369.37/mL | not offered |
NO BOXED WARNINGS
Principal riskInfection risk and hypogammaglobulinemia
Classes and tags
Clinical profile
Legacy pregnancy categoryN/A (post-2015 labeling)
Defining liabilityB-cell depletion, infections and injection reactions