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Here for
your patients
Start your patients on EMPAVELI in 3 steps
Here’s what to do when you’re ready to prescribe
step1
Enroll in the EMPAVELI REMS
Visit
EMPAVELIREMS.COM
to enroll in the EMPAVELI Risk and Evaluation Mitigation Strategy (REMS) program before writing your first prescription. You will only need to enroll once.
  • Because of the risk of serious infections, EMPAVELI is available only through a restricted distribution program, the EMPAVELI REMS. The EMPAVELI REMS requires prescribers and pharmacies to enroll in the program.
  • Prescribers 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.
See more information about THE EMPAVELI REMS
step2
Complete the EMPAVELI Start Form
Download the
EMPAVELI Start Form
. The EMPAVELI Start Form contains the actual prescription for EMPAVELI.
  • Complete the EMPAVELI Start Form in its entirety
  • Review the REMS requirements with your patient
  • Have them sign the Patient Authorizations on Page 1 of the EMPAVELI Start Form
  • Review the Patient Consents section on Page 4 of the EMPAVELI Start Form with your patient
Download EMPAVELI Start Form
step3
Fax the EMPAVELI Start Form
Fax the completed EMPAVELI Start Form to ApellisAssist at
(888) 754-1285
Complete the EMPAVELI Start Form
when you are ready to prescribe
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ApellisAssist logo image
can be reached at
1-866-MY-APL-ASSIST (1-866-692-7527)
from 8 AM-8 PM ET, Monday-Friday
ApellisAssist can also connect your patients to a PANTHERx Rare pharmacist who is on call 24 hours per day.
Here for your patients
ApellisAssist is a program designed to help your patients along their treatment journey.
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The Care Team, comprised of the Care Coordinator through our specialty pharmacy, PANTHERx Rare, and an Apellis Care Educator, will support patients as they prepare to start treatment with EMPAVELI. Together, they’ll make decisions tailored to your patients’ preferences, such as:

  • Their preference of in-person or telehealth self-infusion training
  • Their preference of communication style
  • Their desired frequency of calls or text reminders
Care coordinator image
Care Coordinator
A dedicated coordinator who will work with patients one-on-one to help:
  • Explain their insurance benefits and coverage options
  • Review available financial assistance programs
  • Manage their product and infusion supply shipments
Care Educator
Care Educator
A compassionate care partner with a nursing background who will help:
  • Provide in-person or virtual training and education on how your patients can self-infuse EMPAVELI
  • Address questions about EMPAVELI or PNH
APELLISASSIST IS A PROGRAM DESIGNED TO HELP YOUR PATIENTS ALONG THEIR TREATMENT JOURNEY
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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.