Ultomiris Disease Interactions

Ravulizumab is contraindicated in patients with unresolved Neisseria meningitidis infection. Life-threatening meningococcal infections have occurred in patients treated with ravulizumab, and the drug has shown to increases patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis). Patients that will receive treatment should be vaccinated for meningococcal disease according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with complement deficiencies, and revaccinated in accordance with ACIP recommendations considering the duration of ravulizumab therapy. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of ravulizumab. If urgent ravulizumab therapy is indicated in an unvaccinated patient, meningococcal vaccine(s) should be administered as soon as possible with 2 weeks of antibacterial drug prophylaxis. Patients receiving ravulizumab, should be closely monitored for early signs and symptoms of meningococcal infection and if infection is suspected patients need immediate evaluation.

Ravulizumab blocks terminal complement activation; therefore, patients may have increased susceptibility to encapsulated bacteria infections, especially those caused by Neisseria meningitidis, but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Children treated with ravulizumab are at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b. Vaccination according to clinical guidelines to prevent these types of infection is recommended. If ravulizumab therapy is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection.

The effect of severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) on ravulizumab pharmacokinetics is unknown.