Ultomiris

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease according to ACIP guidelines. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to treatment. Give 2 weeks of antibacterial prophylaxis if ravulizumab must be initiated immediately and vaccines administered <2 weeks before starting therapy. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Discontinue ravulizumab if undergoing treatment for meningococcal infection. Risk of other infections (eg, due to N. species [including gonococcal infections], S. pneumoniae, H. influenza); monitor closely for signs of worsening infection. PNH: risk of hemolysis and other reactions (eg, thrombosis) after treatment discontinuation; monitor closely for at least 16 weeks; if hemolysis (eg, elevated LDH) occurs, consider restarting ravulizumab. aHUS: risk of TMA complications after treatment discontinuation; monitor for at least 12 months; if TMA occurs, consider reinitiating ravulizumab or organ-specific supportive measures. On-body injector (uses acrylic adhesive); consider premedication in those with known allergy. Pregnancy. Nursing mothers: not recommended (during and for 8 months after last dose).

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease according to ACIP guidelines. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to treatment. Give 2 weeks of antibacterial prophylaxis if ravulizumab must be initiated immediately and vaccines administered <2 weeks before starting therapy. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Discontinue ravulizumab if undergoing treatment for meningococcal infection. Risk of other infections (eg, due to N. species [including gonococcal infections], S. pneumoniae, H. influenza); monitor closely for signs of worsening infection. PNH: risk of hemolysis and other reactions (eg, thrombosis) after treatment discontinuation; monitor closely for at least 16 weeks; if hemolysis (eg, elevated LDH) occurs, consider restarting ravulizumab. aHUS: risk of TMA complications after treatment discontinuation; monitor for at least 12 months; if TMA occurs, consider reinitiating ravulizumab or organ-specific supportive measures. On-body injector (uses acrylic adhesive); consider premedication in those with known allergy. Pregnancy. Nursing mothers: not recommended (during and for 8 months after last dose).