Approved Risk Evaluation and Mitigation Strategies (REMS)

Empaveli (Pegcetacoplan)
NDA #215014
REMS last update: 05/14/2021



What is the purpose of the REMS?

The goal of the REMS is to mitigate the occurrence and morbidity associated with encapsulated bacteria infections (Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae Type B) by educating healthcare providers and patients about:
  1. the potential risk of infections caused by encapsulated bacteria with Empaveli
  2. the need for vaccination and antibiotic prophylaxis, if required,
  3. the early signs of invasive encapsulated bacteria infections, and
  4. the need for immediate medical evaluation of signs and symptoms consistent with possible encapsulated bacteria infections

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

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 the applicantto ensure that all processes and procedures are in place and are being followed.

Healthcare providers who prescribe EMPAVELI must:

To become certified to prescribe
Before treatment initiation at least 2 weeks before first dose
  • Assess the patient's vaccination status and immunize if needed according to the current Advisory Committee on Immunization Practices for the following: Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae type B.
  • Provide the patient with a prescription for a 2-week course of antibiotic prophylaxis if EMPAVELI must be started less than 2 weeks after the patient was immunized.
  • Counsel the patient using the Patient Safety Guide and Patient Wallet Card. Provide a copy of the materials to the patient.
    | Patient Wallet Card | | Patient Safety Guide |
At all times
  • Report cases of serious bacterial infection, including the patient's clinical outcomes, to Apellis Pharmaceuticals, Inc.
During treatment
  • Assess the patient for early signs and symptoms of serious bacterial infection and treat immediately, if infection is suspected.
  • Consider discontinuing EMPAVELI in patients who are being treated for a serious bacterial infection.
  • Revaccinate patients according to the current Advisory Committee on Immunization Practices Recommendations.

Patients who are prescribed EMPAVELI:

Before treatment initiation at least 2 weeks before first dose
  • Get Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae type B vaccines as directed by your doctor.
  • Take antibiotics as directed by your doctor for 2 weeks after you get your vaccine(s) if you have to start EMPAVELI right away.
  • Receive counseling from the prescriber using the Patient Safety Guide and Patient Wallet Card.
    | Patient Wallet Card | | Patient Safety Guide |
During treatment
  • Get Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae Type B vaccines as directed by your doctor.
At all times
  • Inform the 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; shortness of breath; extreme pain or discomfort; headache with nausea or vomiting; high heart rate; headache and a fever; headache with a stiff neck or stiff back; confusion; muscle aches with flu-like symptoms; clammy skin; eyes sensitive to light.
  • Have the Patient Wallet Card with you.
    | Patient Wallet Card |

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 Program on behalf of the pharmacy.
  • Have the Authorized Representative review the Healthcare Provider Brochure.
    | Healthcare Provider Brochure |
  • Have the Authorized Representative enroll in the REMS by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
    | Pharmacy Enrollment Form |
  • Train all relevant staff involved in dispensing EMPAVELI using the Healthcare Provider Brochure.
    | Healthcare Provider Brochure |
  • Establish processes and procedures to contact the prescriber to assess the patient’s vaccination history including antibiotic prophylaxis and document the findings.
Before dispensing
  • Obtain authorization to dispense each prescription by contacting the REMS Program to verify the prescriber is certified.
  • Assess the patient’s vaccination history including antibiotic prophylaxis by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS Program.
To maintain certification to dispense
  • If the Authorized Representative changes, have the new Authorized Representative enroll in the REMS by completing the Pharmacy Enrollment Form and submitting it to the REMS.
    | Pharmacy Enrollment Form |
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 dispensers.
  • 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 the applicant, to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Empaveli REMS, see the DailyMed link(s).
Material Name Material Name Link
Healthcare Provider Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Healthcare_Provider_Brochure.pdf
Patient Safety Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Patient_Safety_Guide.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Patient_Wallet_Card.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_Prescriber_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_REMS_Full.pdf
REMS Program Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Empaveli_2021_05_14_REMS_Program_Website.pdf

What updates have been made to the REMS?

Date Summary of change
05/14/2021 Approval of the REMS

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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