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The goal of the BLENREP REMS is to mitigate the risk of ocular toxicity.
Prescribers monitor patients for ocular toxicity by assessing ophthalmic exam findings at baseline and during treatment as described in the Prescribing Information.
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 Program Overview and Education Program for
Prescribers.
Successfully complete the Knowledge Assessment and submit it to
the REMS.
Enroll by completing and submitting the Prescriber Enrollment Form
to the REMS.
Before treatment initiation (first dose)
Counsel the patient on the risk of ocular toxicity and the need for
monitoring via ophthalmic exams at baseline, before each dose of
BLENREP, promptly for new or worsening symptoms, and as
clinically indicated using the Patient Guide.
Provide the patient with the Patient Guide.
Enroll the patient by completing and submitting the Patient
Enrollment Form to the REMS.
Assess the patient’s ocular health by consulting an eye care
professional to conduct a baseline ophthalmic exam using the
Eye Care Professional Exam Form.
Assess the patient’s baseline ophthalmic exam findings for
appropriateness of initiating treatment. Document and submit to
the REMS using the Patient Status Form.
During treatment; before each dose
Assess the patient’s ocular health by consulting an eye care
professional to conduct ophthalmic exams using the Eye Care
Professional Exam Form.
Assess the patient’s ophthalmic exam findings for appropriateness
of continuing treatment. Document and submit to the REMS using
the Patient Status Form.
At all times
Assess the patient for new or worsening ophthalmic symptoms and
consult an eye care professional as clinically indicated.
Patients who are prescribed BLENREP:
Before treatment initiation
Review the Patient Guide.
Receive counseling from the healthcare provider on the risk of eye
problems and the need for eye exams using the Patient Guide.
Enroll in the REMS by completing the Patient Enrollment Form with
the healthcare provider. Enrollment information will be provided to
the REMS.
Get an eye exam.
During treatment; before each
dose
Get an eye exam.
At all times
Inform the healthcare provider right away of any new or worsening
eye symptoms or vision changes.
Get eye exams as needed for any new or worsening eye problems,
as described in the Patient Guide.
Healthcare settings that dispense BLENREP 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.
Have the Authorized Representative review the Program Overview
and Education Program for Healthcare Settings.
Have the Authorized Representative enroll in the REMS by
completing and submitting the Healthcare Setting Enrollment Form
to the REMS.
Train all relevant staff involved in dispensing BLENREP using the
Program Overview and Education Program for Healthcare Settings.
Before dispensing
Report the healthcare setting, prescriber, and patient information,
including the infusion data to the REMS.
Obtain authorization to dispense each dose by contacting the REMS
to verify the prescriber is certified, the healthcare setting is
certified, and the patient is enrolled and authorized to receive the
drug.
To maintain certification to
dispense
Have a new Authorized Representative enroll by completing and
submitting the Healthcare Setting Enrollment Form to the REMS, if
the authorized representative changes.
At all times
Not distribute, transfer, loan, or sell BLENREP, except to
REMS-certified healthcare settings.
Maintain records documenting staff’s completion of training.
Maintain records that all processes and procedures are in place and
being followed.
Comply with audits carried out by GlaxoSmithKline LLC or a third
party acting on behalf of GlaxoSmithKline LLC to ensure that all
training, processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute BLENREP must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified healthcare settings.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified healthcare settings.
Maintain records that all processes and procedures are in place and
are being followed.
Maintain and submit records of all drug distribution to the REMS.
Comply with audits carried out by GlaxoSmithKline LLC or a third
party acting on behalf of GlaxoSmithKline LLC 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.
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
10/23/2025
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.
