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ofatumumab (Arzerra, Kesimpta)

Indications: - previously treated chronic lymphocytic leukemia (CLL) - multiple sclerosis: relapsing-remitting disease, active secondary progressive disease, or clinically isolated syndrome (Kesimpta) [3] Contraindications: - not recommended for: - chronic lymphocytic leukemia (CLL) [2] - severe persistent asthma [2] Dosage: - 12 doses by intravenous infusion - 300 mg initial dose - followed 1 week later by 2000 mg weekly for 7 doses - followed 4 weeks later by 2000 mg every 4 weeks for 4 doses - multiple sclerosis: 20 mg monthly subcutaneous injection [3] Adverse effects: - common (>=10%) -neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, upper respiratory tract infections. - does not appear to increase Covid-19 severity [4] Boxed warning: - risk of reactivation of hepatitis B infection [2] Mechanism of action: - monoclonal antibody directed against CD20

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

antineoplastic monoclonal antibody

References

  1. Prescriber's Letter 17(2): 2010 New Drugs Approved by the FDA in 2009 Detail-Document#: 260213 (subscription needed) http://www.prescribersletter.com
  2. FDA Drug Safety Communication: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab). September 25, 2013 http://www.fda.gov/Drugs/DrugSafety/ucm366406.htm
  3. George J New MS Drug Approved - Ofatumumab is first self-administered, targeted B-cell treatment for relapsing MS. MedPage Today August 20, 2020 https://www.medpagetoday.com/neurology/multiplesclerosis/88195 - George J Year in Review: Multiple Sclerosis - New drugs, new challenges with COVID-19. MedPage Today December 3, 2020 https://www.medpagetoday.com/neurology/multiplesclerosis/89991
  4. George J New MS Drug Does Not Appear to Increase COVID Severity. Most COVID cases were mild or moderate in patients treated with ofatumumab. MedPage Today October 29, 2021 https://www.medpagetoday.com/meetingcoverage/cmsc/95341