FDA.reportPublic FDA data

Empaveli - Apellis Pharmaceuticals, Inc.

Manufacturer
Apellis Pharmaceuticals, Inc.
Effective date
2025-07-28
Label type
Risk Evaluation & Mitigation Strategies
Version
7
Source
full-release
Hydrated at
2026-06-04 22:50:41

Label at a glance#

ProductEmpaveli
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Serious infections caused by encapsulated bacteria
Application Number: NDA 215014
Application Holder: Apellis Pharmaceuticals, Inc.
Initial REMS Approval: 05/2021
Most Recent REMS Update: 07/2025

II. REMS Goal

REMS Goals

The goal of the EMPAVELI REMS is to mitigate the risk of serious infections caused by encapsulated bacteria.

  1. Patients are vaccinated against infections caused by encapsulated bacteria (Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y, and B) prior to starting therapy according to current Advisory Committee on Immunization Practices (ACIP) recommendations and receive antibacterial drug prophylaxis if needed.
  2. Patients are aware of early signs and symptoms of serious encapsulated bacterial infections and the need for immediate medical evaluation.
  3. Prescribers are aware of early signs and symptoms of serious encapsulated bacterial infections and the need for immediate medical evaluation.

III. REMS Requirements

REMS REQUIREMENTS

Apellis Pharmaceuticals, Inc. must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

REMS PARTICIPANT REQUIREMENTS

1. Healthcare providers who prescribe EMPAVELI must:
To become certified to prescribe
  • Review the drug's Prescribing Information.
  • Review the following: Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card.
  • Enroll by completing and submitting the Prescriber Enrollment Form to the REMS.
Before treatment initiation
  • Assess the patient for unresolved serious infections caused by encapsulated bacteria.
  • For patients with an unresolved serious infection caused by encapsulated bacteria: Not initiate EMPAVELI.
  • Assess the patient's vaccination status for Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y, and B and vaccinate, as needed, according to the current Advisory Committee on Immunization Practices (ACIP) recommendations.
  • For patients who are not up to date with pneumococcal and meningococcal vaccines at least 2 weeks prior to initiation of treatment and who must start EMPAVELI urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
  • Counsel the patient using the Patient Guide and Patient Safety Card. Provide a copy of the materials to the patient.
  • Counsel the patient on the need to carry the Patient Safety Card at all times during treatment and for 2 months following the last dose of EMPAVELI.
During treatment
  • Assess the patient for early signs and symptoms of serious bacterial infection and evaluate immediately if infection is suspected.
  • Vaccinate patients as needed according to the current ACIP recommendations.
At all times
  • Report adverse events suggestive of serious bacterial infections, including the patient's clinical outcomes, to Apellis Pharmaceuticals, Inc.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed EMPAVELI:
Before treatment initiation
  • Get vaccinated as directed by your prescriber against the following encapsulated bacteria: Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y, and B.
  • Take antibiotics as directed by your prescriber if you have to start EMPAVELI right away.
  • Receive counseling from your prescriber using the Patient Guide and Patient Safety Card.
  • Get the Patient Guide and Patient Safety Card from your prescriber.
During treatment
  • Get additional vaccines as directed by your prescriber.
At all times during treatment and for 2 months after the last dose
  • Inform your prescriber or get emergency medical care right away if any of the following occur: fever with or without shivers or the chills; fever and a rash; fever with chest pain and cough; fever with breathlessness or fast breathing; fever with high heart rate; headache with nausea or vomiting; headache and fever; headache with a stiff neck or stiff back; confusion; body aches with flu-like symptoms; clammy skin; eyes sensitive to light.
  • Have the Patient Safety Card with you.

REMS PARTICIPANT REQUIREMENTS

3. Pharmacies that dispense EMPAVELI must:
To become certified to dispense
  • Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  • Have the Authorized Representative review the Healthcare Provider Safety Brochure.
  • Have the Authorized Representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form to the REMS.
  • Train all relevant staff involved in dispensing EMPAVELI using the Healthcare Provider Safety Brochure.
  • Establish processes and procedures to contact the prescriber to assess the patient's vaccination status for up to date pneumococcal and meningococcal vaccines according to current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings.
  • For patients who are not up to date with pneumococcal and meningococcal vaccines when starting treatment: Establish processes and procedures to assess the patient's vaccination status for up to date pneumococcal and meningococcal vaccines including antibacterial drug prophylaxis, if needed, by contacting the prescriber before dispensing prescriptions for up to 6 months after the first dose and document the findings.
Before dispensing, first dose
  • Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
  • Assess the patient's vaccination status for up to date pneumococcal and meningococcal vaccines according to current ACIP recommendations including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, for up to 6 months after the first dose
  • Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
  • For patients who are not initially up to date with pneumococcal and meningococcal vaccines when starting treatment: Assess the patient's vaccination status for up to date pneumococcal and meningococcal vaccines including antibacterial drug prophylaxis, if needed, by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, 6 months after the first dose and thereafter
  • Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
To maintain certification to dispense
  • If the Authorized Representative changes, have a new Authorized Representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form to the REMS.
At all times
  • Report adverse events suggestive of serious bacterial infections to Apellis Pharmaceuticals, Inc.
  • Not distribute, transfer, loan, or sell EMPAVELI, except to certified pharmacies.
  • Maintain records of staff's completion of REMS training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits carried out by Apellis Pharmaceuticals, Inc. or a third party acting on behalf of Apellis Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

4. Wholesalers-distributors that distribute EMPAVELI must:
To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  • Train relevant staff involved in EMPAVELI distribution on the REMS requirements.
At all times
  • Distribute only to certified pharmacies.
  • Maintain records of all drug distributions.
  • Comply with audits carried out by Apellis Pharmaceuticals, Inc. or a third party acting on behalf of Apellis Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

Apellis Pharmaceuticals, Inc. must provide training to healthcare providers who prescribe EMPAVELI.

The training includes the following educational materials: Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card. The training must be available online and by hard copy via fax and mail.

REMS APPLICANT REQUIREMENTS

Apellis Pharmaceuticals, Inc. must provide training to pharmacies that dispense EMPAVELI.

The training includes the following educational material: Healthcare Provider Safety Brochure. The training must be available online and by hard copy via fax and mail.

SPL UNCLASSIFIED SECTION

To support REMS operations, Apellis Pharmaceuticals, Inc. must:

  • Establish and maintain a REMS Website, www.EMPAVELIREMS.com. The REMS Website must include the capability to complete prescriber certification and enrollment online and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).
  • Make the REMS Website fully operational and all REMS materials available through the REMS Website and REMS Coordinating Center within 120 calendar days of modification approval (07/28/2025).
  • Establish and maintain a REMS Coordinating Center for REMS participants at 1-888-343-7073.
  • Establish and maintain a validated, secure database of all REMS participants who are certified in the EMPAVELI REMS, and patient-specific information on vaccination and antibacterial drug prophylaxis.
  • Ensure prescribers are able to enroll in the REMS by fax and online.
  • Ensure pharmacies are able to enroll in the REMS by fax.
  • Ensure pharmacies are able to obtain authorization to dispense by phone or online.
  • Ensure pharmacies are able to report vaccination and antibacterial drug prophylaxis information online.
  • Ensure prescribers and pharmacies are able to report adverse events suggestive of serious bacterial infections by phone.
  • Ensure that once a report suggestive of a serious bacterial infection is received, Apellis Pharmaceuticals, Inc. will follow-up with the healthcare provider to obtain all required data. This requirement does not affect Apellis Pharmaceutical's, Inc. other reporting and follow-up requirements under FDA regulations.
  • Provide the Prescriber Enrollment Form, Healthcare Provider Safety Brochure, Patient Guide, Patient Safety Card, Medication Guide, and the Prescribing Information to prescribers who (1) attempt to prescribe EMPAVELI and are not yet certified or (2) inquire about how to become certified.
  • Provide the Pharmacy Enrollment Form and Healthcare Provider Safety Brochure to pharmacies that (1) attempt to order/dispense EMPAVELI and are not yet certified or (2) inquire about how to become certified.
  • Notify prescribers and pharmacies within 2 business days after they become certified in the REMS.
  • Provide certified pharmacies access to the database of certified prescribers and, for pharmacies that opt to use the EMPAVELI REMS Website for data submission, access to patient-specific information on vaccination and antibacterial drug prophylaxis.
  • Provide certified prescribers access to the database of certified pharmacies.
  • Provide authorized wholesalers-distributors access to the database of certified pharmacies.
SPL UNCLASSIFIED SECTION

To ensure REMS participants' compliance with the REMS, Apellis Pharmaceuticals, Inc. must:

  • Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to, records of: EMPAVELI distribution and dispensing; certification of prescribers and pharmacies; and audits of REMS participants. These records must be readily available for FDA inspections.
  • Verify annually that the designated Authorized Representative's name and contact information correspond to those of the current designated Authorized Representative for the pharmacy. If different, the pharmacy must be required to re-certify with a new Authorized Representative.
  • Establish and maintain a plan for addressing noncompliance with REMS requirements.
  • Monitor prescribers and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including decertification.
  • Audit pharmacies no later than 120 days after the pharmacy receives their first shipment, and annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and comply with the REMS requirements.
  • Audit wholesalers-distributors no later than 120 days after their first commercial distribution of EMPAVELI, and annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and comply with the REMS requirements.
  • Take reasonable steps to improve operations of and compliance with the requirements of the EMPAVELI REMS based on monitoring and evaluation of the EMPAVELI REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Apellis Pharmaceuticals, Inc. must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Apellis Pharmaceuticals, Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the EMPAVELI REMS:

Enrollment Forms

  • Prescriber:
    • Prescriber Enrollment Form
  • Pharmacy:
    • Pharmacy Enrollment Form

Training and Educational Materials

  • Prescriber:
    • Healthcare Provider Safety Brochure
  • Patient:
    • Patient Guide
    • Patient Safety Card
  • Pharmacy:
    • Healthcare Provider Safety Brochure

Other Materials

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use:
    • Healthcare providers who prescribe EMPAVELI are specially certified under 505-1(f)(3)(A)
    • Pharmacies that dispense EMPAVELI are specially certified under 505-1(f)(3)(B)
    • EMPAVELI is dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D)
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

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Product conceptRelationVersionEffective
da70f326-eccc-4ddc-93bb-212c53d94fc7Product name120231002
d1a4c427-3368-4f7b-a9d9-d408ab477de6Product name120211208

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021SPL related document2026-08-21Apellis Pharmaceuticals, Inc. | Juzen Chemical Corporation | Bachem AG | Eurofins Lancaster Laboratories, LLC | Eurofins Advantar Laboratories, LLC | Bora Pharmaceuticals Injectables Inc. | Nelson Laboratories, LLC | AndersonBrecon Inc | Cenexi HSC20250905_8751c5ea-cd2b-4b93-964a-592d4e8bd224.zip!b7237e7b-d777-4f71-9cee-b9458d284ac8.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EmpaveliPEGCETACOPLANApellis Pharmaceuticals, Inc.c23d89e9-b00b-4520-e053-2995a90a95af2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Empaveli

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