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BKEMV - Amgen Inc

Manufacturer
Amgen Inc
Effective date
2026-03-26
Label type
Risk Evaluation & Mitigation Strategies
Version
14
Source
full-release
Hydrated at
2026-06-04 22:50:44

Label at a glance#

ProductBKEMV
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Serious meningococcal infections
Application Number: BLA 761333
Application Holder: Amgen Inc.
Initial REMS Approval: 05/2024
Most Recent REMS Updated: 03/2026

II. REMS Goal

REMS GOALS

The goal of the BKEMV 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

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

REMS PARTICIPANT REQUIREMENTS

1. Healthcare providers who prescribe BKEMV 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
  1. Assess the patient for unresolved meningococcal infection.
  2. For patients with unresolved serious meningococcal infection: Not initiate BKEMV.
  3. 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.
  4. For patients who are not up to date with meningococcal vaccines at least two weeks prior to initiation of treatment and who must start BKEMV urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
  5. Counsel the patient using the Patient Safety Card and Patient Guide. Provide a copy of the materials to the patient.
  6. Counsel the patient on the need to carry the Patient Safety Card.
During treatment
  1. Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately if infection is suspected.
  2. Vaccinate patients as needed according to the current ACIP recommendations for meningococcal vaccinations for patients receiving a complement inhibitor.
At all times
  1. Report adverse events suggestive of meningococcal infection, including the patient's clinical outcomes, to Amgen Inc.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed BKEMV:
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 BKEMV right away.
  3. Receive counseling from the prescriber using the Patient Safety Card and Patient Guide.
  4. Get the Patient Safety Card and Patient Guide from your prescriber.
During treatment
  1. Get additional meningococcal vaccines as directed by your prescriber.
At all times during treatment and for 3 months after the last dose
  1. Have the Patient Safety Card with you.
  2. 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 BKEMV 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 BKEMV using the Healthcare Provider Safety Brochure.
  5. Establish processes and procedures to contact the prescriber 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, by contacting the prescriber before dispensing prescriptions up to 6 months after the first dose and document the findings.
Before dispensing, first dose
  1. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
  2. 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, by contacting the prescriber 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
  1. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
  2. 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, 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
  1. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
To maintain certification to dispense
  1. 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
  1. Report adverse events suggestive of meningococcal infections to Amgen Inc.
  2. Not distribute, transfer, loan, or sell BKEMV, except to other certified healthcare settings or certified pharmacies.
  3. Maintain records of staff's completion of REMS training.
  4. Maintain records that all processes and procedures are in place and are being followed.
  5. Comply with audits carried out by Amgen Inc. or a third party acting on behalf of Amgen Inc. to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

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

REMS APPLICANT REQUIREMENTS

SPL UNCLASSIFIED SECTION

Amgen Inc. must provide training to healthcare providers who prescribe BKEMV.

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.

Amgen Inc. must provide training to healthcare settings and pharmacies that dispense BKEMV.

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, Amgen Inc. must:

  1. Establish and maintain a REMS Website, www.BKEMVREMS.com. The REMS Website must include the capability to complete prescriber and healthcare setting and pharmacy certification and enrollment by fax, email, and 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).
  2. Make the REMS Website fully operational and all REMS materials available through the REMS Website and Coordinating Center by the date BKEMV is first commercially distributed.
  3. Establish and maintain a REMS Call Center at 1-866-718-6927.
  4. Establish and maintain a validated, secure database of all certified prescribers, and certified healthcare settings and pharmacies in the BKEMV REMS.
  5. Ensure that healthcare settings and pharmacies are able to obtain authorization to dispense by phone and online.
  6. Ensure that prescribers, healthcare settings, and pharmacies are able to enroll by fax, email, and online.
  7. Ensure that prescribers, and healthcare settings and pharmacies are able to report adverse events suggestive of meningococcal infections by phone.
  8. Ensure that once a report suggestive of meningococcal infection is received, Amgen Inc. will follow up with the healthcare providers to obtain all required data. This requirement does not affect Amgen Inc.'s other reporting and follow-up requirements under the FDA regulations.
  9. Provide the Prescriber Enrollment Form, Healthcare Provider Safety Brochure, Patient Safety Card, Patient Guide, Medication Guide, and the BKEMV Prescribing Information to healthcare providers who (1) attempt to prescribe BKEMV and are not yet certified or (2) inquire about how to become certified.
  10. 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.
  11. Notify prescribers, and healthcare settings and pharmacies within 2 business days after they become certified in the REMS.
  12. Provide certified prescribers access to the database of certified healthcare settings and pharmacies.
  13. Provide certified healthcare settings and pharmacies access to a database of certified prescribers.
  14. Provide authorized wholesalers-distributors access to a database of certified healthcare settings and pharmacies.

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

  1. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: BKEMV distribution and dispensing; certification of prescribers, and healthcare settings and pharmacies; and audits of REMS participants. These records must be readily available for FDA inspections.
  2. Verify annually that the designated Authorized Representative name and contact information correspond to those of the current designated Authorized Representative for each healthcare setting and pharmacy. If different, then the healthcare setting or pharmacy must be required to re-certify with a new Authorized Representative.
  3. Establish and maintain a plan for addressing noncompliance with REMS requirements.
  4. 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.
  5. Audit certified healthcare settings and pharmacies no later than 180 calendar days after they become certified, 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.
  6. Audit wholesalers-distributors no later than 180 calendar days after their first commercial distribution of BKEMV and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and comply with the REMS requirements.
  7. Take reasonable steps to improve operations of and compliance with the requirements in the BKEMV REMS based on monitoring and evaluation of the BKEMV REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Amgen Inc. must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS (05/28/2024). 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. Amgen 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 BKEMV REMS:

Enrollment Forms

SPL UNCLASSIFIED SECTION

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

Training and Educational Materials

SPL UNCLASSIFIED SECTION

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

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 BKEMV are specially certified under 505-1(f)(3)(A)
    • Healthcare settings and pharmacies that dispense BKEMV are specially certified under 505-1(f)(3)(B)
    • BKEMV 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 BKEMV safely and effectively. See full prescribing information for BKEMV. BKEMV ® (eculizumab-aeeb) injection, for intravenous use Initial U.S. Approval: 2024 BKEMV (eculizumab-aeeb) 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 between the bSPL related document2026-07-02Amgen Inc20260410_290ddfe1-176a-4a6f-91fe-200881152ed5.zip!6629daf6-4e80-4256-a087-85e2d0116c22.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BKEMVECULIZUMAB-AEEBAmgen Inc002f9748-b0e8-4b6e-a38b-56930a8394912026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BKEMV

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