Empaveli Generic Name & Formulations
Pegcetacoplan 54mg/mL; soln for SC infusion.
Single-dose vials (20mL)—8
Mechanism of Action
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. Pegcetacoplan acts proximally in the complement cascade controlling both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis.
Treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Empaveli Dosage and Administration
Give by SC infusion into abdomen, thighs, hips, upper arms over 30mins (if using 2 infusion sites) or 60mins (if using 1 infusion site). Rotate infusion sites; avoid tattoos, scars, stretch marks, or where the skin is tender, bruised, red, or hard. Administer 1080mg twice weekly via infusion pump with a reservoir of ≥20mL. For LDH levels >2×ULN: adjust to 1080mg every 3 days; for dose increase: monitor LDH twice weekly for at least 4 weeks. Switching from eculizumab: initiate pegcetacoplan while continuing eculizumab at current dose; after 4 weeks discontinue eculizumab. Switching from ravulizumab: initiate pegcetacoplan no more than 4 weeks after the last dose of ravulizumab.
Individuals not vaccinated against certain encapsulated bacteria unless the risks of delaying pegcetacoplan therapy outweigh the risks of a bacterial infection with an encapsulated organism. Unresolved serious infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae.
Empaveli Boxed Warnings
Serious infections caused by encapsulated bacteria.
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).
Half-life: 8 days.
May interfere with silica reagents in coagulation panels and result in artificially prolonged activated partial thromboplastin time (aPTT); avoid concomitant use.
Empaveli Adverse Reactions
Inj-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, fatigue; serious infections (may be fatal), infusion-related reactions.
Empaveli Clinical Trials
Empaveli Patient Counseling