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The goal of the BLENREP REMS is to manage the risk of ocular toxicity by:
Ensuring that healthcare providers are educated on the risk of ocular toxicity associated with the use of BLENREP
Ensuring that healthcare providers are educated and adhere to the following:
submit documentation that ophthalmic exams are being done at baseline and prior to each dose to identify ocular toxicity
counsel patients on the risk of ocular toxicity and the requirement for monitoring via ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms as described in the Prescribing Information
Ensuring safe use of BLENREP by:
Ensuring that BLENREP is infused in certified healthcare settings only after verification of ophthalmic exams
Ensuring that patients are informed about:
the risk of ocular toxicity associated with the use of BLENREP
the requirement for ophthalmic exams at baseline, prior to each dose and promptly for worsening symptoms, 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.
Successfully complete the Knowledge Assessment and submit it
to the REMS Program.
| Knowledge Assessment |
Enroll in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS Program.
| Prescriber Enrollment Form |
Before treatment initiation
(first dose)
Counsel the patient on the risks associated with BLENREP,
including the ocular toxicity and the requirement for monitoring
via ophthalmic examinations (e.g., visual acuity and slit lamp) at
baseline, prior to each dose, and promptly for worsening
symptoms using the Patient Guide.
| REMS Patient Guide |
Enroll the patient by completing and submitting the Patient
Enrollment Form to the REMS Program.
| Patient Enrollment Form |
Assess the patient’s ocular health by consulting an eye care
professional to complete visual acuity and slit lamp examinations
using the Eye Care Professional Consult Request Form.
| REMS Eye Care Professional Consult Request Form |
Assess the patient’s ophthalmic consult results for
appropriateness of initiating treatment. Document and submit to
the REMS Program using the Patient Status Form.
| Patient Status Form |
During treatment; before each
infusion
Assess the patient’s ocular health by consulting an eye care
professional to complete visual acuity and slit lamp examinations
using the Eye Care Professional Consult Request Form.
Infusion
| REMS Eye Care Professional Consult Request Form |
Assess the patient’s ophthalmic consult results for
appropriateness of continuing treatment. Document and submit to
the REMS Program using the Patient Status Form.
| Patient Status Form |
Patients who are prescribed BLENREP:
Before treatment initiation
Receive counseling from the prescriber using the Patient Guide.
| REMS Patient Guide |
Enroll in the REMS Program by completing the Patient Enrollment
Form with the prescriber. Enrollment information will be provided
to the REMS Program.
| Patient Enrollment Form |
Get an eye exam.
During treatment; before each
infusion
Get an eye exam.
At all times
Inform the prescriber if you have signs or symptoms of worsening
eyesight or eye health.
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
Program on behalf of the healthcare setting.
Have the authorized representative enroll in the REMS Program by
completing the Healthcare Setting Enrollment Form and submitting it
to the REMS Program.
| Healthcare Setting Enrollment Form |
Establish processes and procedures to verify the REMS Checklist is
completed and submitted for each patient.
| REMS Checklist |
Before administering
Obtain authorization to dispense each dose by contacting the REMS
Program to verify that the prescriber is certified, and the patient is
enrolled and authorized to receive the drug.
Submit the REMS Checklist to the REMS Program.
| REMS Checklist |
To maintain certification to
dispense
Have a new authorized representative enroll in the REMS Program by
completing and submitting the Healthcare Setting Enrollment Formto
the REMS program.
| Healthcare Setting Enrollment Form |
At all times
Not distribute, transfer, loan, or sell BLENREP.
Maintain records documenting 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 GlaxoSmithKline or third party
acting on behalf of GlaxoSmithKline to ensure that all 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 of all drug distribution.
Comply with audits carried out by GlaxoSmithKline or a third party
acting on behalf of GlaxoSmithKline 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.
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
03/02/2022
Revised to reflect editorial changes.
12/07/2021
Modified REMS to:
Incorporate the revised validity time frame of authorization for patients to receive their next scheduled dose of Blenrep based on their ophthalmic examination date in the REMS Document
Allow patients to provide verbal acknowledgement to enroll into the Blenrep REMS in the Patient Enrollment Form
Add a data entry field for “dose ordered in mg/kg” and
“actual dose administered” in the REMS Checklist
Update to the portal to improve
visibility of patient status and treatment history, granting delegates access to the online
portal, allowing prescribers to add or remove delegates online, and editorial revisions on
the Eye Care Professional Consult Request Form, Patient Enrollment Form, REMS
Checklist and Education Program for both Prescribers and Healthcare Settings and
Website screenshots.
11/20/2020
Modified to make provisions for prescriber delegates
to access the BLENREP REMS public portal in order to perform REMS prescriber
activities online and provide online functionality for prescribers ability to add or remove
prescriber delegates from the online portal. The order of questions in the final lay out
version of the Patient Status Form was also rearranged. In addition, editorial changes
were made to the REMS materials including the Patient Status and Program Overview.
09/10/2020
Revised to reflect editorial changes.
08/05/2020
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.
