Ofatumumab (Arzerra, Novartis) is an anti-CD20 monoclonal antibody approved for the treatment of CLL. The drug is to be administered as an IV infusion. In this section, the common adverse reactions, warnings and precautions, drug interactions and other contraindications associated with ofatumumab use are explained.
Common adverse reactions
Warnings and precautions
Drug interactions and other contraindications
Ofatumumab common adverse reactions
The following adverse reactions were reported by at least 10% of participants in clinical trials:
- patients with previously untreated CLL: infusion reactions and neutropenia;
- patients with relapsed CLL: infusion reactions, neutropenia, febrile neutropenia and leukopenia;
- patients with CLL receiving ofatumumab as extended treatment: infusion reactions, neutropenia and upper respiratory tract infection; and
- patients with refractory CLL: neutropenia, pneumonia, fever, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis and upper respiratory tract infection.
Ofatumumab warnings and precautions
Ofatumumab is associated with infusion reactions, which are more likely to occur after the first two infusions. Depending on the severity of the reaction, treatment may need to be interrupted or discontinued. Because of the risk for infusion reaction, patients should be premedicated with a corticosteroid, an antihistamine and acetaminophen.
Ofatumumab is also associated with the following adverse events:
- HBV infection or HBV reactivation;
- tumor lysis syndrome; and
Ofatumumab drug interactions and other contraindications
Patients should not be vaccinated with any live virus vaccines during or soon after completing treatment with ofatumumab.