FDA.reportPublic FDA data

EPYSQLI - Samsung Bioepis Co., Ltd.

Manufacturer
Samsung Bioepis Co., Ltd.
Effective date
2026-04-28
Label type
Risk Evaluation & Mitigation Strategies
Version
12
Source
full-release
Hydrated at
2026-06-04 22:50:45

Label at a glance#

ProductEPYSQLI
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Serious meningococcal infections

Application Number: BLA 761340 (and Unbranded biological product)

Application Holder: Samsung Bioepis Co., Ltd.

Initial REMS Approval: 07/2024

Most Recent REMS Update: 04/2026

II. REMS Goal

REMS Goals

The goal of the EPYSQLI REMS is to mitigate the risk of serious meningococcal infections.

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

III. REMS Requirements

REMS REQUIREMENTS

REMS PARTICIPANT REQUIREMENTS

Samsung Bioepis Co., Ltd. must ensure that healthcare providers, patients, healthcare settings, pharmacies, and wholesalers-distributors comply with the following requirements:

1. Healthcare providers who prescribe EPYSQLI must:
To become certified to prescribe 1. Review the drug's Prescribing Information.
2. Review the following: Healthcare Provider Safety Brochure, Patient Safety Card, and Patient Guide.
3. Enroll by completing and submitting the Prescriber Enrollment Form to the REMS.
Before treatment initiation 4. Assess the patient for unresolved meningococcal infection.
5. For patients with an unresolved serious meningococcal infection: Not initiate EPYSQLI.
6. Assess the patient's vaccination status for meningococcal serogroups A, C, W, Y, and B and vaccinate as needed according to the current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
7. For patients who are not up to date with meningococcal vaccines at least two weeks prior to initiation of treatment and who must start EPYSQLI urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
8. Counsel the patient using the Patient Safety Card and Patient Guide. Provide a copy of the materials to the patient.
9. Counsel the patient on the need to carry the Patient Safety Card.
During treatment 10. Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately if infection is suspected.
11. Vaccinate patients as needed according to the current ACIP recommendations for meningococcal vaccinations for patients receiving a complement inhibitor.
At all times 12. Report adverse events suggestive of meningococcal infection, including the patient's clinical outcomes, to Samsung Bioepis Co., Ltd, or a third party acting on behalf of Samsung Bioepis Co., Ltd.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed EPYSQLI:
Before treatment initiation 1. Get meningococcal vaccines for serogroups A, C, W, Y, and B as directed by your prescriber.
2. Take antibiotics as directed by your prescriber if you have to start EPYSQLI right away.
3. Receive counseling from your prescriber using the Patient Safety Card and Patient Guide.
4. Get the Patient Safety Card and Patient Guide from your prescriber.
During treatment 5. Get additional meningococcal vaccines as directed by your prescriber.
At all times during treatment and for 3 months after the last dose 6. Have the Patient Safety Card with you.
7. Inform your prescriber or get emergency medical care right away if you experience any of the following: fever; fever and a rash; fever with high heart rate; headache with nausea or vomiting; headache and fever; headache with stiff neck or stiff back; confusion; eyes sensitive to light; muscle aches with flu-like symptoms.

REMS PARTICIPANT REQUIREMENTS

3. Healthcare Settings and pharmacies that dispense EPYSQLI must:
To become certified to dispense 1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
2. Have the Authorized Representative review the Healthcare Provider Safety Brochure.
3. Have the Authorized Representative enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
4. Train all relevant staff involved in dispensing EPYSQLI using the Healthcare Provider Safety Brochure.
5. Establish processes and procedures to assess the patient's vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis, if needed, before treatment initiation and document the findings.
6. For patients who are not up to date with meningococcal vaccines when starting treatment: Establish processes and procedures to assess the patient's vaccination status for up to date meningococcal vaccines including antibacterial drug prophylaxis, if needed, before dispensing prescriptions up to 6 months after the first dose and document the findings.
Before dispensing, first dose 7. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
8. Assess the patient's vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, and document the findings through the processes and procedures established as a requirement of the REMS.
Before dispensing, up to 6 months after the first dose 9. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
10. For patients who are not initially up to date with meningococcal vaccines when starting treatment: Assess the patient's vaccination status for up to date meningococcal vaccines for serogroups A, C, W, Y, and B including antibacterial drug prophylaxis, if needed, 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 11. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
To maintain certification to dispense 12. If the Authorized Representative changes, have a new Authorized Representative enroll by completing and submitting the Healthcare Setting and Pharmacy Enrollment Form to the REMS.
At all times 13. Report adverse events suggestive of meningococcal infection to Samsung Bioepis Co., Ltd, or a third party acting on behalf of Samsung Bioepis Co., Ltd.
14. Not distribute, transfer, loan, or sell EPYSQLI, except to certified healthcare settings and certified pharmacies.
15. Maintain records of staff's completion of REMS training.
16. Maintain records that all processes and procedures are in place and are being followed.
17. Comply with audits carried out by Samsung Bioepis Co., Ltd. or a third party acting on behalf of Samsung Bioepis Co., Ltd. to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

4. Wholesalers-distributors that distribute EPYSQLI must:
To be able to distribute 1. Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings and certified pharmacies.
2. Train relevant staff involved in EPYSQLI distribution on the REMS requirements.
At all times 3. Distribute only to certified healthcare settings and certified pharmacies.
4. Maintain records of all drug distribution.
5. Comply with audits carried out by Samsung Bioepis Co., Ltd. or a third party acting on behalf of Samsung Bioepis Co., Ltd. to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

Samsung Bioepis Co., Ltd. must provide training to healthcare providers who prescribe EPYSQLI.

The training includes the following educational materials: Healthcare Provider Safety Brochure, Patient Safety Card, and Patient Guide. The training must be available online and in hardcopy format via mail.

Samsung Bioepis Co., Ltd. must provide training to healthcare settings and pharmacies that dispense EPYSQLI.

The training includes the following educational material: Healthcare Provider Safety Brochure. The training must be available online and in hardcopy format via mail.

To support REMS operations, Samsung Bioepis Co., Ltd. must:

  • Establish and maintain a REMS Website, www.EPYSQLIREMS.com. The REMS Website must include the capability to complete prescriber, and healthcare setting and pharmacy certification or 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 the Call Center by the date EPYSQLI is first commercially distributed.
  • Establish and maintain a REMS Call Center at 1-866-318-0342.
  • Establish and maintain a validated, secure database of all certified prescribers, and certified healthcare settings and pharmacies in the EPYSQLI REMS, and patient-specific information on vaccination and antibacterial drug prophylaxis.
  • Ensure that healthcare settings and pharmacies are able to obtain authorization to dispense by phone or online.
  • Ensure prescribers, healthcare settings, and pharmacies are able to enroll by fax and online.
  • Ensure that prescribers, healthcare settings, and pharmacies, are able to report vaccination and antibacterial drug prophylaxis information online and by phone and fax.
  • Ensure prescribers, and healthcare settings and pharmacies are able to report adverse events suggestive of meningococcal infections by phone.
  • Ensure that once a report suggestive of meningococcal infection is received, Samsung Bioepis Co., Ltd., will follow up with the healthcare providers to obtain all required data. This requirement does not affect Samsung Bioepis Co., Ltd.'s other reporting and follow-up requirements under FDA regulations.
  • Provide the Prescriber Enrollment Form, Healthcare Provider Safety Brochure, Patient Safety Card, Patient Guide, Medication Guide and the EPYSQLI Prescribing Information to healthcare providers who (1) attempt to prescribe EPYSQLI and are not yet certified or (2) inquire about how to become certified.
  • Provide the Healthcare Setting and Pharmacy Enrollment Form and Healthcare Provider Safety Brochure to healthcare settings and pharmacies that (1) attempt to order/dispense and are not yet certified or (2) inquire about how to become certified.
  • Notify prescribers, and healthcare settings and pharmacies within 2 business days after they become certified in the REMS.
  • Provide certified prescribers access to the database of certified healthcare settings and pharmacies, and patient-specific information on vaccination and antibacterial drug prophylaxis.
  • Provide certified healthcare settings and pharmacies access to the database of certified prescribers, and patient-specific information on vaccination and antibacterial drug prophylaxis.
  • Provide authorized wholesalers-distributors a list of certified healthcare settings and pharmacies.

To ensure REMS participants' compliance with the REMS, Samsung Bioepis Co., Ltd. must:

  • Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: EPYSQLI distribution and dispensing; certification of prescribers, and healthcare settings and pharmacies; patient-specific information on vaccination and antibacterial drug prophylaxis; 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 each healthcare setting and pharmacy. If different, the healthcare setting or 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 healthcare settings and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including de-certification.
  • Audit certified healthcare settings and pharmacies no later than 180 calendar days after they receive their first shipment and a representative sample of certified healthcare settings and pharmacies annually thereafter, to ensure that all processes and procedures are in place, functioning, and comply with the REMS requirements.
  • Audit wholesalers-distributors no later than 180 calendar days after their first commercial distribution of EPYSQLI and annually thereafter to ensure that all 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 EPYSQLI REMS based on monitoring and evaluation of the EPYSQLI REMS.

IV. REMS Assessment Timetable

REMS Timetable For Submission Assessments

Samsung Bioepis Co., Ltd. must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS (07/19/2024). 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. Samsung Bioepis Co., Ltd. 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 EPYSQLI REMS:

Enrollment Forms

  • Prescriber:
    • Prescriber Enrollment Form
  • Healthcare Setting and Pharmacy:
    • Healthcare Setting and Pharmacy Enrollment Form

Training and Educational Materials

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

Other Materials

    • REMS Website

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 EPYSQLI are specially certified under 505-1(f)(3)(A)
    • Healthcare settings and pharmacies that dispense EPYSQLI are specially certified under 505-1(f)(3)(B)
    • EPYSQLI 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 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 EPYSQLI safely and effectively. See full prescribing information for EPYSQLI. EPYSQLI ® (eculizumab-aagh) injection, for intravenous use Initial U.S. Approval: 2024 EPYSQLI (eculizumab-aagh) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA approved biological product, known as a reference product, and that there are no clinically meaningful differences betweSPL related document2024-11-26Samsung Bioepis Co., Ltd.20260513_8bc96abf-40e6-488a-b094-c9a81a03eb3f.zip!89514e6a-cc5f-4c5e-83e1-6fb2e17dd4ac.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPYSQLIECULIZUMAB-AAGHTeva Pharmaceuticals USA, Inc.1fa1aa80-1c59-44d4-9841-b6c52882651b2026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: EPYSQLI

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