For US HCPs

For US HCPs

CONNECT WITH A REP
BLENREP (belantamab mafodotin-blmf) logo.
CONNECT WITH A REP
CONNECT WITH A REP

Understanding ocular toxicity and information for coordinating care between oncologists and eye care professionals

Prescribers of BLENREP and eye care professionals (ECPs), defined as ophthalmologists and optometrists, will work together to help monitor ocular toxicity and manage dosage modifications for patients1

Ocular toxicity occurred in 92% of patients in DREAMM-71

In DREAMM-7, Grade 3 or 4 ocular toxicity occurred in 77% of patients.

 

Ocular toxicity is defined as changes in the corneal epithelium and changes in Best-Corrected Visual Activity (BCVA) based on ophthalmic exam findings or ocular adverse reactions per CTCAE v5.0

Ocular Toxicity: Ophthalmic Exam Findings
Definition Incidence & Severity
Requires 2 exams conducted by an eye care professional (ophthalmologist or optometrist)2,3:
  • Change in BCVA, which is a score reported as a fraction, such as 20/20, using a Snellen eye chart
  • Corneal exam findings, which are observed by a slit lamp
  • Ocular toxicity based on ophthalmic exam findings was reported as Grade 2 in 9% of patients, Grade 3 in 56% of patients, and Grade 4 in 21% of patients. The median time to onset of the first Grade 2 to 4 ophthalmic exam findings was 43 days (range: 15 to 611 days). The median duration of all Grade 2 to 4 ophthalmic exam findings was 85 days (range: 5 to 813 days). Patients experienced a median of 3 (range: 1 to 11) episodes of ocular toxicity based on ophthalmic exam findings. Of the patients with Grade 2 to 4 ophthalmic exam findings, 42% had improvement of the last event to Grade 1 or better; 22% had resolution of the last event based on return to baseline or normal ophthalmic exam findings
  • The most commonly reported corneal exam findings included superficial punctate keratopathy, microcyst-like deposits, epithelial changes, and haze. Cases of corneal ulcer, including cases with infection, have been reported and should be managed promptly by an eye care professional
  • A reduction in BCVA to 20/50 or worse in at least 1 eye occurred in 69% of patients, including 29% who experienced a change in BCVA to 20/100 or worse, and 12% who experienced a change in BCVA to 20/200 or worse

Click here to download a resource to help patients throughout their treatment journey

BLENREP Risk Evaluation and Mitigation Strategy (REMS)1

BLENREP is available only through a restricted program called the BLENREP REMS because of the risk of ocular toxicity

 

Notable requirements of the BLENREP REMS include the following:

  • Prescribers must be certified in the BLENREP REMS by enrolling and completing training
  • Prescribers must counsel patients receiving BLENREP on the risk of ocular toxicity, the need for monitoring via ophthalmic exams prior to each dose, and provide patients with the BLENREP REMS Patient Guide
  • Patients must be enrolled in the BLENREP REMS and adhere to monitoring
  • Healthcare settings that dispense BLENREP must be certified in the BLENREP REMS by enrolling and must obtain authorization prior to dispensing
  • Wholesalers and distributors must distribute BLENREP only to certified healthcare settings

 

Further information is available at www.BLENREPREMS.com and 1-855-690-9572

In the clinical trial, dosage modifications were required for ocular toxicity1

Click below to read guidance on how to help patients with their experience on BLENREP

    Resolution of Best-Corrected Visual Acuity (BCVA)1,4

      BLENREP + bortezomib and dexamethasone4
    N = 242
    Event Of the patients with reduction in BCVA in at least one eye of:
    20/50 or worse 20/100 or worse 20/200 or worse

    Patients with at least one event, n/N (%)

    		 166/242 (69%)
    		 69/242 (29%)
    		 29/242 (12%)
    • Resolution of patients with last event to baseline or better, n/N (%)*
    		 101/166 (61%) 39/69 (57%) 14/29 (48%)

    Ongoing event as of last follow-up, n/N (%)

    • On treatment
    24/166 (14%)
    9/69 (13%)
    4/29 (14%)
    • Discontinued treatment, follow-up ongoing
    		 17/166 (10%) 9/69 (13%) 5/29 (17%)
    • Discontinued treatment, follow-up ended
    		 24/166 (14%) 12/69 (17%) 6/29 (21%)

    • *The last event is "Resolved" only if it's resolved in both eyes; if either eye is ongoing, the event is "Ongoing."4

    Considerations for ophthalmic exam findings before and during treatment1

    Ophthalmic exams (including slit lamp exam and BCVA assessment) must be conducted by an eye care professional, such as an ophthalmologist or optometrist, at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated.

    Perform baseline exam within 4 weeks prior to the first dose. Perform each follow-up exam within 10 days prior to the next planned dose. All effort should be made to schedule the exam as close to BLENREP dosing as possible.

    Considerations of ocular toxicity image.

    The BLENREP eye drop supportive care program provides patients with eye drops throughout their treatment for free. Visit togetherwithBLENREPHCP.com for more information.

    For eye care professionals (ECPs), ophthalmologists and optometrists1:

    ECPs will monitor patients for potential ocular toxicity (at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated).

    Eye exams must include:

    • Best-Corrected Visual Acuity (BCVA) test

    • Slit lamp test (corneal exam)

    ECPs will share exam results with BLENREP prescribers through a standardized Eye Care Professional Exam Form with a grading scale.

    Based on ECP’s grading of eye exam results, prescribers of BLENREP will determine if a dosage modification, including a dosage reduction, temporary interruption, or permanent discontinuation will be needed due to ocular toxicity.1
    Visit the Resources tab to download information to help coordinate patient care.

    Patients will be sent to an eye care professional to obtain ophthalmic exams before starting BLENREP, before each dose, promptly for any new or worsening eye symptoms, and as clinically indicated

    Counsel patients to read the FDA-approved medication guide for BLENREP. In addition, counsel them to1:

    Tell their healthcare provider if they notice any new or worsening eye symptoms.
    Administer preservative-free artificial tears at least 4 times a day until the end of treatment.
    Avoid contact lenses until the end of treatment. Bandage contact lenses may be used under the direction of an eye care professional.
    Use caution when driving or operating machinery, as BLENREP may adversely affect their vision.

    BCVA=Best-Corrected Visual Acuity; CTCAE=Common Terminology Criteria for Adverse Events; ECP=eye care professional; HCP=healthcare professional; REMS=Risk Evaluation and Mitigation Strategy.

    INDICATION & IMPORTANT SAFETY INFORMATION

    INDICATION

    IMPORTANT SAFETY INFORMATION

    INDICATION

    BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

    IMPORTANT SAFETY INFORMATION

    WARNING: OCULAR TOXICITY
    • BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred.
    • Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modification due to ocular toxicity. Withhold BLENREP until improvement and resume or permanently discontinue, based on severity.
    • Because of the risk of ocular toxicity, BLENREP is available only through a restricted program called the BLENREP Risk Evaluation and Mitigation Strategy (REMS).

     

    WARNINGS AND PRECAUTIONS

    Ocular Toxicity

    BLENREP causes ocular toxicity, defined as changes in the corneal epithelium and changes in BCVA based on ophthalmic exam (including slit lamp exam), or other ocular adverse reactions as defined by the CTCAE.

    In DREAMM-7, ocular toxicity occurred in 92% of patients, including Grade 3 or 4 in 77% of patients. The most common ocular toxicities (>25%) were reduction in BCVA (89%) and corneal exam findings (86%) based on ophthalmic exam findings, blurred vision (66%), dry eye (51%), photophobia (47%), foreign body sensation in eyes (44%), eye irritation (43%), and eye pain (33%).

     

    Ocular toxicity based on ophthalmic exam findings was reported as Grade 2 in 9% of patients, Grade 3 in 56% of patients, and Grade 4 in 21% of patients. The median time to onset of the first Grade 2 to 4 ophthalmic exam findings was 43 days (range: 15 to 611 days). The median duration of all Grade 2 to 4 ophthalmic exam findings was 85 days (range: 5 to 813 days). Patients experienced a median of 3 episodes (range: 1 to 11 episodes) of ocular toxicity based on ophthalmic exam findings. Of the patients with Grade 2 to 4 ophthalmic exam findings, 42% had improvement of the last event to Grade 1 or better; 22% had resolution of the last event based on return to baseline or normal ophthalmic exam findings.

     

    The most commonly reported corneal exam findings included superficial punctate keratopathy, microcyst-like deposits, epithelial changes, and haze. Cases of corneal ulcer, including cases with infection, have been reported and should be managed promptly by an eye care professional.

    A reduction in BCVA to 20/50 or worse in at least one eye occurred in 69% of patients, including 29% who experienced a change in BCVA to 20/100 or worse, and 12% who experienced a change in BCVA to 20/200 or worse. Of the patients with reduced BCVA to 20/50 or worse in at least one eye, 61% had resolution of the last event to baseline or better. Of the patients with reduced BCVA to 20/100 or worse, 57% had resolution of the last event. Of the patients with reduced BCVA to 20/200 or worse, 48% had resolution of the last event.

     

    Ophthalmic exams (including slit lamp exam and BCVA assessment) should be conducted by an eye care professional, such as an ophthalmologist or optometrist, at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated. Perform baseline exam within 4 weeks prior to the first dose. Perform each follow-up exam within 10 days prior to the next planned dose. All effort should be made to schedule the exam as close to BLENREP dosing as possible. Withhold BLENREP until improvement in both corneal exam findings and change in BCVA to Grade 1 or less and resume at same or reduced dose or permanently discontinue based on severity.

    Counsel patients to promptly inform their healthcare provider of any ocular symptoms. Counsel patients to use preservative-free artificial tears at least 4 times a day starting with the first infusion and continuing until the end of treatment, and to avoid wearing contact lenses for the duration of therapy. Bandage contact lenses may be used under the direction of an eye care professional.

     

    Changes in visual acuity may be associated with difficulty for driving and reading. Counsel patients to use caution when driving or operating machinery.

     

    BLENREP Risk Evaluation and Mitigation Strategy (REMS)

    BLENREP is available only through a restricted program called the BLENREP REMS because of the risk of ocular toxicity.
     

    Further information is available at www.BLENREPREMS.com and 1-855-690-9572.
     

    Thrombocytopenia

    Thrombocytopenia of any grade occurred in 100% of patients in DREAMM-7.

    Grade 2 thrombocytopenia occurred in 10% of patients, Grade 3 in 29% of patients, and Grade 4 in 45% of patients. Clinically significant bleeding (Grade ≥2) occurred in 7% of patients with concomitant low platelet levels (Grade 3 or 4).
     

    Monitor complete blood cell counts at baseline and periodically during treatment as clinically indicated. Withhold or reduce the dose of BLENREP based on severity.
     

    Embryo-fetal Toxicity

    Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells.
     

    Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose.
     

    ADVERSE REACTIONS

    The most common adverse reactions (≥20%) with BLENREP in combination with bortezomib and dexamethasone are reduction in BCVA, corneal exam findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, upper respiratory tract infection, hepatotoxicity, eye pain, diarrhea, fatigue, pneumonia, cataract and COVID-19.

     

    The most common Grade 3 or 4 (≥10%) laboratory abnormalities are decreased platelets, decreased lymphocytes, decreased neutrophils, increased gamma-glutamyl transferase, decreased white blood cells, and decreased hemoglobin.
     

    Please see full Prescribing Information, including Boxed Warning.

    To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
    FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    References

    1. BLENREP. Prescribing information. GSK; 2025.
    2. Hungria V, Robak P, Hus M, et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2024;391(5)(suppl):l-31. doi:10.1056/NEJMoa2405090
    3. Liu G, Volpe N, Galetta S. The Neuro-Ophthalmic Examination. Neuro-Ophthalmology: Diagnosis and Management. Elsevier Inc; 2010:7-36.
    4. Data on file, GSK.
    Together with BLENREP logo.

    If your patients need help paying for their medicines or want to learn about other patient access and reimbursement services, please visit this website or call 1-844-4GSK-ONC (1-844-447-5662).