What are the common adverse reactions to Kesimpta (ofatumumab)?

From the Guidelines

Common adverse reactions to Kesimpta (ofatumumab) that you should discuss with your patient include upper respiratory tract infections, headache, and injection-related reactions. These adverse effects are related to Kesimpta's mechanism as a B-cell depleting therapy, which affects the immune system 1. Injection site reactions typically involve redness, pain, itching, or swelling at the injection site and usually occur within 24 hours of administration. Patients may also experience systemic injection reactions including fever, headache, muscle pain, chills, and fatigue, particularly after the first injection. Other frequent side effects include urinary tract infections, back pain, and decreased immunoglobulin levels. More serious but less common reactions include serious infections, progressive multifocal leukoencephalopathy (PML), and hepatitis B reactivation. Some key points to consider when discussing Kesimpta with your patient:

• The most common adverse reactions are infusion-related reactions, which can be mitigated with proper prophylaxis and monitoring 1
• Patients with a history of rituximab intolerance may still be eligible for Kesimpta, but should be closely monitored for signs of infusion-related reactions 1
• Kesimpta has been shown to be effective in patients with Waldenström's macroglobulinemia, with an overall response rate of 59% 1
• Patients should be advised to report any signs of infection, unusual bruising or bleeding, or new neurological symptoms promptly. It's worth noting that the provided evidence does not directly mention Kesimpta, but rather ofatumumab, which is the same medication. The evidence from 1 and 1 provides the most relevant information on the adverse reactions and efficacy of ofatumumab.

From the FDA Drug Label

The most common adverse reactions (≥10%) were infusion reactions, neutropenia, leukopenia and febrile neutropenia Infusion reactions may include, but are not limited to, chills, dyspnea, flushing, hypotension, nausea, pain, pruritus, pyrexia, rash, and urticaria Adverse reactions associated with decreased platelet counts (including but not limited to thrombocytopenia, platelet count decreased and pancytopenia) and decreased hemoglobin (including but not limited to anemia, hemoglobin decreased and pancytopenia)

The common adverse reactions to ofatumumab (Kesimpta) include:

• Infusion reactions: 60% of patients experienced infusion reactions, with 9% being Grade 3 or higher 2
• Neutropenia: 55% of patients experienced neutropenia, with 49% being Grade 3 or higher 2
• Leukopenia: 15% of patients experienced leukopenia, with 12% being Grade 3 or higher 2
• Febrile neutropenia: 10% of patients experienced febrile neutropenia, with 10% being Grade 3 or higher 2
• Bronchitis: 6% of patients experienced bronchitis, with 1% being Grade 3 or higher 2
• Decreased platelet counts: 30% of patients experienced decreased platelet counts, with 15% being Grade 3 or higher 2
• Decreased hemoglobin: 23% of patients experienced decreased hemoglobin, with 10% being Grade 3 or higher 2

From the Research

Common Adverse Reactions to Kesimpta

The following are common adverse reactions to Kesimpta:

• Nasopharyngitis 3
• Headache 3, 4, 5
• Upper respiratory tract infections 3, 4, 6
• Urinary tract infections 3, 5
• Fatigue 6, 5
• Nausea 4, 6, 5
• Pyrexia 6, 5
• Pneumonia 6, 5
• Chills 5
• Pain 5
• Vomiting 5
• Injection-related reactions 3
• Infections 3

Less Common Adverse Reactions

Less common adverse reactions to Kesimpta include:

• Neutropenia 6
• Anemia 6
• Dyspnea 6
• Rash 6
• Bronchitis 6
• Infusion reactions 6
• Asthenia 5
• Hypoesthesia 5
• Dizziness 5
• Malaise 5
• Injection site pain 5
• Paresthesia 5
• Diarrhea 5