EMPAVELI is the
first subcutaneous treatment for
PNH that may be self-infused1
What to know before prescribing EMPAVELI
  • 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 Advisory Committee on Immunization Practices (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
  • Healthcare professionals who prescribe EMPAVELI must enroll in the EMPAVELI REMS before writing their first prescription
EMPAVELI can be self-administered using a commercially available infusion pump that can deliver doses up to 20 mL
EMPAVELI is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous infusion, a patient may self-administer, or the patient’s caregiver may administer EMPAVELI, if a healthcare provider determines that it is appropriate.

Refer to the EMPAVELI Instructions for Use and the infusion pump manufacturer’s instructions for full preparation and administration information.
2x weekly 1080-mg subcutaneous infusion
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EMPAVELI provides the flexibility to self-infuse at home or other locations that are convenient for your patients*
Patients can be trained on the self-infusion of EMPAVELI in the way(s) they are most comfortable, including by a healthcare professional, or with the help of an Apellis Care Educator, who can provide step-by-step training and support.
*EMPAVELI must be refrigerated at 2˚C to 8˚C (36˚F to 46˚F) and in the original carton to protect from light1
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Is EMPAVELI right for your patients with PNH?
EMPAVELI might be right for your
patients with PNH who:
Have persistently low Hb levels
Require ≥1 transfusion per year
Starting patients on EMPAVELI
Dosing: EMPAVELI is administered twice weekly as a 1080-mg subcutaneous infusion.
For patients transitioning off eculizumab:
  • Administer EMPAVELI twice-weekly in addition to the patient's current dose of eculizumab for the first 4 weeks
  • After 4 weeks of concomitant therapy, discontinue eculizumab and start EMPAVELI monotherapy for the
    duration of therapy
For patients transitioning off ravulizumab:
  • 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
Dose adjustments
  • For LDH levels greater than 2X the upper limit of normal (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 Doses
  • Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose
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.
How to infuse EMPAVELI
Watch the video to learn how patients should self-infuse EMPAVELI
video play button
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Learn more about additional resources that can help support your patients as they start EMPAVELI
Learn more
Hb=hemoglobin; IVH=intravascular hemolysis; LDH=lactate dehydrogenase; PNH=paroxysmal nocturnal hemoglobinuria.

Reference: 1. EMPAVELI [prescribing information]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2021.

Indication and Important Safety Information

INDICATION

EMPAVELI™ (pegcetacoplan) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

IMPORTANT SAFETY INFORMATION

EMPAVELI™ (pegcetacoplan) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

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

The most common adverse reactions (incidence ≥10% of patients) with EMPAVELI vs. eculizumab were injection-site reactions (39% v. 5%), infections (29% v. 26%), diarrhea (22% v. 3%), abdominal pain (20% v. 10%), respiratory tract infection (15% v. 13%), viral infection (12% v. 8%), and fatigue (12% v. 23%).

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.