Ultomiris

Increased risk of serious meningococcal infections (septicemia and/or meningitis). Complete or update meningococcal vaccination according to current ACIP guidelines at least 2 weeks prior to initiation; revaccinate according to duration of therapy. If urgent ravulizumab therapy is indicated in an unvaccinated patient, give antibacterial drug prophylaxis and these vaccines as soon as possible. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Consider ravulizumab interruption if undergoing treatment for serious meningococcal infection. Risk of other infections (eg, due to N. species [including gonococcal infections], S. pneumoniae, H. influenza); give prophylactic vaccinations accordingly. 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). Complete or update meningococcal vaccination according to current ACIP guidelines at least 2 weeks prior to initiation; revaccinate according to duration of therapy. If urgent ravulizumab therapy is indicated in an unvaccinated patient, give antibacterial drug prophylaxis and these vaccines as soon as possible. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Consider ravulizumab interruption if undergoing treatment for serious meningococcal infection. Risk of other infections (eg, due to N. species [including gonococcal infections], S. pneumoniae, H. influenza); give prophylactic vaccinations accordingly. 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). Complete or update meningococcal vaccination according to current ACIP guidelines at least 2 weeks prior to initiation; revaccinate according to duration of therapy. If urgent ravulizumab therapy is indicated in an unvaccinated patient, give antibacterial drug prophylaxis and these vaccines as soon as possible. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Consider ravulizumab interruption if undergoing treatment for serious meningococcal infection. Risk of other infections (eg, due to N. species [including gonococcal infections], S. pneumoniae, H. influenza); give prophylactic vaccinations accordingly. 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).