Management of Kesimpta (Ofatumumab) During Active Infection
Kesimpta (ofatumumab) should be temporarily withheld until resolution of an active infection. 1
Rationale for Withholding Kesimpta During Active Infection
- The FDA label for Kesimpta explicitly states that if a patient has an active infection, healthcare providers should delay treatment with Kesimpta until the infection is resolved 1
- Kesimpta is a B-cell depleting therapy that targets CD20, which can impair immune responses and potentially worsen existing infections 1
- Serious infections, which can be life-threatening or cause death, can occur during treatment with Kesimpta and other anti-CD20 therapies 1
- Immunosuppressive therapy, including B-cell depleting agents, should be temporarily withheld until resolution of active infection (Evidence Level 5) 2
Types of Infections Requiring Withholding Therapy
- Bacterial infections requiring antibiotic therapy are considered serious enough to warrant holding Kesimpta 2
- Viral infections, particularly those causing systemic symptoms, may require withholding Kesimpta until resolution 2
- Invasive fungal infections should prompt immediate withholding of Kesimpta 2
- For opportunistic infections, including Pneumocystis jirovecii, Legionella pneumophila, and Salmonella species, immunomodulator therapy should be temporarily withheld until resolution 2
Monitoring for Infection Resolution
- Monitor for clinical improvement in symptoms (fever, chills, cough, body aches) 1
- Ensure normalization of inflammatory markers before restarting therapy 3
- For bacterial infections, complete the full course of antibiotics before considering restarting Kesimpta 3
- Wait at least 1-2 weeks after completion of antibiotics to ensure no recurrence of infection before restarting Kesimpta 3
Special Considerations
- Patients with a history of recurrent infections may need more prolonged withholding of therapy and closer monitoring 2
- For patients with neutropenia and infection, address both the infection and neutropenia before restarting Kesimpta 2
- In patients with chronic infections that cannot be completely eradicated, consult with infectious disease specialists before continuing or restarting Kesimpta 2
- For patients with hepatitis B virus (HBV) infection, Kesimpta is contraindicated in active HBV disease, and patients with prior HBV infection require monitoring during therapy 1
When to Restart Therapy
- Only restart Kesimpta after complete resolution of the active infection 2, 1
- Ensure the patient has completed the full course of antimicrobial therapy 3
- Verify absence of fever, systemic symptoms, and normalization of inflammatory markers 3
- For serious infections, consider a follow-up evaluation to confirm resolution before restarting therapy 2
Common Pitfalls to Avoid
- Restarting Kesimpta too early before complete infection resolution, which may lead to worsening infection or recurrence 2
- Failing to recognize that even mild infections may become serious in immunocompromised patients 2
- Not completing the full course of antimicrobial therapy before restarting Kesimpta 3
- Overlooking the need for prophylaxis against certain opportunistic infections in high-risk patients 2