Self-administration with EMPAVELI
EMPAVELI can be self-administered using a commercially available infusion pump with a reservoir of at least 20 mL.1
/ At-home self-administration that may fit into
a patient’s lifestyle
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
EMPAVELI® (pegcetacoplan) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
Meningococcal infections may occur in patients treated with EMPAVELI and may become rapidly life-threatening or fatal if not recognized and treated early. Use of EMPAVELI may predispose individuals to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B.
- Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria.
- Vaccinate patients at least 2 weeks prior to administering the first dose of EMPAVELI unless the risks of delaying therapy with EMPAVELI outweigh the risk of developing a serious infection.
- Vaccination reduces, but does not eliminate, the risk of serious infections. Monitor patients for early signs of serious infections and evaluate immediately if infection is suspected.
EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the EMPAVELI REMS, prescribers must enroll in the program.
CONTRAINDICATIONS
- Hypersensitivity to pegcetacoplan or to any of the excipients
- Not currently vaccinated against certain encapsulated bacteria, unless the risks of delaying EMPAVELI treatment outweigh the risks of developing a bacterial infection with an encapsulated organism
- Unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated Bacteria
The use of EMPAVELI may predispose individuals to serious, life-threatening, or fatal infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B (Hib). To reduce the risk of infection, all patients must be vaccinated against these bacteria according to the most current ACIP recommendations for patients with altered immunocompetence associated with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI.
For patients without known history of vaccination, administer required vaccines at least 2 weeks prior to receiving the first dose of EMPAVELI. If immediate therapy with EMPAVELI is indicated, administer required vaccine as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.
Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider discontinuation of EMPAVELI in patients who are undergoing treatment for serious infections.
EMPAVELI REMS
Because of the risk of serious infections, EMPAVELI is available only through a restricted program under a REMS. Under the EMPAVELI REMS, prescribers must enroll in the program and must counsel patients about the risk of serious infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated against encapsulated bacteria. Enrollment and additional information are available by telephone: 1-888-343-7073 or at www.empavelirems.com.
Infusion-Related Reactions
Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria) have occurred in patients treated with EMPAVELI. One patient (less than 1% in clinical studies) experienced a serious allergic reaction which resolved after treatment with antihistamines. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.
Monitoring PNH Manifestations after Discontinuation of EMPAVELI
After discontinuing treatment with EMPAVELI, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH levels along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other reactions. If hemolysis, including elevated LDH, occurs after discontinuation of EMPAVELI, consider restarting treatment with EMPAVELI.
Interference with Laboratory Tests
There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.
ADVERSE REACTIONS
Most common adverse reactions in patients with PNH (incidence ≥10%) were injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash.
USE IN SPECIFIC POPULATIONS
Females of Reproductive Potential
EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.
Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide.
The infusion takes about 30 minutes (if using 2 infusion sites) or about 60 minutes (if using 1 infusion site) to complete.1
The length of each needle is 8 mm.
EMPAVELI is intended for use under the guidance of a healthcare professional. Patients should be trained on the self-administration process by a healthcare professional before they use EMPAVELI for the first time. Through the ApellisAssist program, Apellis Care Educators can provide patients with 1-on-1 self-administration training and support.
96% of patients reported they were confident self-administering EMPAVELI after training with an Apellis Care Educator.2,*
*Based on feedback from ~135 people with PNH after receiving self-infusion training with an Apellis Care Educator. They rated their confidence with self-infusion on a scale from 1-7. A score of ≥5 was considered “confident”. Data as of 01/15/2023.2
Patient compliance with
EMPAVELI self-administration is>98%2,†
†Compliance calculated by medical possession ratio of ~100 US patients on EMPAVELI. Data as of 12/2022.2
Vaccination requirements: What to know before prescribing EMPAVELI to your patients1
Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B at least 2 weeks prior to initiation of EMPAVELI therapy according to current ACIP guidelines.
Provide 2 weeks of antibacterial drug prophylaxis to patients if EMPAVELI must be initiated immediately and vaccines are administered less than 2 weeks before starting therapy with EMPAVELI.
The Risk Evaluation and Mitigation Strategy (REMS) program for EMPAVELI1
Because of the risk of serious infections, EMPAVELI is available only through a restricted program under a REMS. Under the EMPAVELI REMS, prescribers must enroll in the program.
Prescribers must counsel patients about the risk of serious infection, provide patients with REMS educational materials, and ensure patients are vaccinated against encapsulated bacteria.
Enrollment in the EMPAVELI REMS and additional information are available by telephone: 1-888-343-7073 or at www.empavelirems.com.
Healthcare professionals who prescribe EMPAVELI must enroll in the REMS for EMPAVELI.Enroll now
Starting patients on EMPAVELI
Dosing: EMPAVELI is administered twice weekly as a 1080-mg subcutaneous infusion.1
For patients transitioning off eculizumab1:
For the first 4 weeks, administer EMPAVELI twice weekly in addition to the patient’s current dose of eculizumab
After 4 weeks of concomitant therapy, discontinue eculizumab and start EMPAVELI monotherapy for the duration of therapy
For patients transitioning off ravulizumab1:
Initiate EMPAVELI no more than 4 weeks after the last dose of ravulizumab
Concomitant treatment helps minimize the risk of hemolysis with abrupt treatment discontinuation.1
Dose adjustments1
For LDH levels greater than 2X the ULN, adjust the dosing regimen to 1080 mg every 3 days
In the event of a dose increase, monitor LDH twice weekly for at least 4 weeks
Missed doses1
Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose
With EMPAVELI, the median effective half-life of elimination is 8.6 days in patients with PNH.1
How to self-administer EMPAVELI
“At first, I was a little worried I would mess up my self-infusion, but with training, it didn't take long to get comfortable with it!”
Peg is a real EMPAVELI patient.
Individual patient experiences may vary.
ACIP=Advisory Committee on Immunization Practices; LDH=lactate dehydrogenase; PNH=paroxysmal nocturnal hemoglobinuria; REMS=Risk and Evaluation Mitigation Strategy; ULN=upper limit of normal.
References: 1. EMPAVELI [prescribing information]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023. 2. Data on file. Apellis Pharmaceuticals, Inc., Waltham, MA.
