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The goal of the BKEMV REMS is to mitigate the risk of serious meningococcal infections.
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.
Patients are aware of early signs and symptoms of meningococcal infection and the need for
immediate medical evaluation.
Prescribers are aware of early signs and symptoms of meningococcal infection and the need for
immediate medical evaluation.
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.
Review the following: Healthcare Provider Safety Brochure, Patient
Safety Card, and Patient Guide.
Enroll by completing and submitting the Prescriber Enrollment Form to
the REMS.
Before treatment initiation
Assess the patient for unresolved meningococcal infection.
For patients with unresolved serious meningococcal infection: Not
initiate BKEMV.
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.
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.
Counsel the patient using the Patient Safety Card and Patient Guide.
Provide a copy of the materials to the patient.
Counsel the patient on the need to carry the Patient Safety Card.
During treatment
Assess the patient for early signs and symptoms of meningococcal
infection and evaluate immediately if infection is suspected.
Vaccinate patients as needed according to the current ACIP
recommendations for meningococcal vaccinations for patients receiving
a complement inhibitor.
At all times
Report adverse events suggestive of meningococcal infection, including
the patient’s clinical outcomes, to Amgen Inc.
Patients who are prescribed BKEMV:
Before treatment initiation
Get meningococcal vaccines for serogroups A, C, W, Y, and B as
directed by your prescriber.
Take antibiotics as directed by your prescriber if you have to start
BKEMV right away.
Receive counseling from the prescriber using the Patient Safety Card
and Patient Guide.
Get the Patient Safety Card and Patient Guide from your prescriber.
During treatment
Get additional meningococcal vaccines as directed by your prescriber.
At all times during treatment
and for 3 months after the
last dose
Have the Patient Safety Card with you.
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.
Healthcare settings and pharmacies that dispense BKEMV 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 healthcare setting or pharmacy.
Have the Authorized Representative review the Healthcare Provider
Safety Brochure.
Have the Authorized Representative enroll by completing and
submitting the Healthcare Setting and Pharmacy Enrollment Form to
the REMS.
Train all relevant staff involved in dispensing BKEMV 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 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.
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
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 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
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 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
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 by completing and submitting the Healthcare
Setting and Pharmacy Enrollment Form to the REMS.
At all times
Report adverse events suggestive of meningococcal infections to
Amgen Inc.
Not distribute, transfer, loan, or sell BKEMV, except to other certified
healthcare settings or 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 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.
Wholesalers-distributors that distribute BKEMV must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified healthcare settings and pharmacies.
Train relevant staff involved in BKEMV distribution on the REMS
requirements.
At all times
Distribute only to certified healthcare settings and pharmacies.
Maintain records of all drug distributions.
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.
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 BKEMV REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
03/26/2026
Modified to consist of:
Edits to selected captured fields and additional instructions for completion on the Healthcare Setting and Pharmacy Enrollment Form
Addition of a Frequently Asked Questions (FAQ) tab on the REMS Website
Functionality improvements on the REMS Website
10/07/2025
Revised to make editorial changes
09/17/2025
Modified to consist of changes to the REMS Document
to align with the language in the Audit Plan.
04/18/2025
Modified to add a “Certified Participant Locator” to the REMS Website and other editorial changes to the REMS materials.
01/30/2025
Modified to add the option for online
certification and enrollment for healthcare settings and pharmacies.
10/23/2024
Modified to include changes to the REMS materials to
incorporate the addition of the new indication for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR)
antibody positive.
05/28/2024
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.
