Approved Risk Evaluation and Mitigation Strategies (REMS)

Blenrep (belantamab mafodotin)
BLA #761158
REMS last update: 09/10/2020



What is the purpose of the REMS?

The goal of the BLENREP REMS is to manage the risk of ocular toxicity by:

  1. Ensuring that healthcare providers are educated on the risk of ocular toxicity associated with the use of BLENREP
  2. Ensuring that healthcare providers are educated and adhere to the following:
    1. submit documentation that ophthalmic exams are being done at baseline and prior to each dose to identify ocular toxicity
    2. 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
  3. Ensuring safe use of BLENREP by:
    1. Ensuring that BLENREP is infused in certified healthcare settings only after verification of ophthalmic exams
  4. Ensuring that patients are informed about:
    1. the risk of ocular toxicity associated with the use of BLENREP
    2. 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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Blenrep must:

To become certified to prescribe
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.
    | 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.
    | 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 |
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.
    | 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.
    | 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 review the Prescribing Information, Program Overview, and Education Program for Health Care Settings.
    | Education Program for Healthcare Settings | | Program Overview |
  • 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 |
  • Train all relevant staff involved in dispensing Blenrep using the Program Overview and Education Program for Health Care Settings.
    | Education Program for Healthcare Settings | | Program Overview |
  • Establish processes and procedures to verify the REMS Checklist is completed and submitted for each patient.
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.
  • Complete the REMS Checklist.
    | REMS Checklist |
After administering, within 5 business days
To maintain certification to dispense
  • Have a new authorized representative enroll in the REMS Program by completing and submitting the Healthcare Setting Enrollment Form to 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.

Material Name Material Name Link
Education Program for Healthcare Settings (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Education_Program_for_Healthcare_Settings.pdf
Education Program for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Education_Program_For_Prescribers.pdf
Eye Care Professional Consult Request Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Eye_Care_Professional_Consult_Request_Form.pdf
Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Fact_Sheet.pdf
Healthcare Provider REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Healthcare_Provider_REMS_Letter.pdf
Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Healthcare_Setting_Enrollment_Form.pdf
Letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Letter_for_Professional_Societies.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Patient_Enrollment_Form.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Patient_Guide.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Patient_Status_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Prescriber_Knowledge_Assessment.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_Program_Overview.pdf
REMS Checklist (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Checklist.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Blenrep_2020_09_10_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
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.

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