Empaveli

Increased risk of serious infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B. Vaccinate or revaccinate against these bacteria according to ACIP guidelines. Immunize patients without a history of vaccination at least 2 weeks prior to treatment. Give 2 weeks of antibacterial prophylaxis if pegcetacoplan must be initiated immediately and vaccines administered <2 weeks before starting therapy. Monitor closely for signs of serious infection; evaluate immediately if infection is suspected. Consider discontinuing pegcetacoplan if undergoing treatment for serious infections. Discontinue immediately if severe hypersensitivity reaction occurs. Risk of hemolysis and other reactions (eg, thrombosis) after treatment discontinuation; monitor closely for at least 8 weeks; if hemolysis (eg, elevated LDH) occurs, consider restarting pegcetacoplan. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for 40 days after the last dose. Nursing mothers: not recommended (during and for 40 days after the last dose).