For US HCPs

For US HCPs

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

Dosing and Administration for BLENREP

BLENREP is delivered by a ~30-minute outpatient infusion, at a REMS-certified site of their choice1,2

  • BLENREP does not have a requirement for hospitalization to initiate treatment2
  • Systemic premedication is not indicated for initial BLENREP dosing, but may be required to address infusion-related reactions1
  • BLENREP allows patients the potential to avoid traveling far for treatment2
  • Ophthalmic exams must be conducted by an eye care professional at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated1
    • Advise patients to use preservative-free artificial tears at least 4 times per day and to avoid wearing contact lenses during treatment with BLENREP unless directed otherwise by their eye care professional1

Overview of BLENREP dosage1

BLENREP dosing chart.

87% of patients required a dosage modification of BLENREP for an adverse reaction.1

For dosing instructions of agents administered in combination with BLENREP, see respective Prescribing Information.

* Reduced Dosage Level 2 is specific to dosage reductions due to ocular toxicity based on ophthalmic exam findings.1

Dosage modifications for ocular toxicity based on ophthalmic exam findings1

  • Recommended dosage modifications are based on ophthalmic exam findings, which include corneal exam findings and change in Best-Corrected Visual Acuity (BCVA) as assessed by an eye care professional
  • 83% of patients required a dosage modification of BLENREP for ocular toxicity based on ophthalmic exam findings or other ocular adverse reactions as defined by the CTCAE
  • 67% of patients required a dosage interruption of BLENREP for ocular toxicity that lasted longer than 3 weeks (time between doses, median: 5.7 weeks (range: 3 to 31 weeks))
  • Do not re-escalate the dose of BLENREP after a dose reduction is made for ocular toxicity based on ophthalmic exam findings

Dosage modifications for ocular toxicity1

BLENREP dosage modifications chart.

*For patients previously on 2.5 mg/kg every 3 weeks, resume treatment at Reduced Dosage Level 1 as per Table 1 in the USPI. For patients previously on 1.9 mg/kg every 3 weeks, resume treatment at Reduced Dosage Level 2 per Table 1 in the USPI.1

† Reduced Dosage Level 2 is specific to dosage reductions due to ocular toxicity based on ophthalmic exam findings.1

Severity Ophthalmic Exam Findings Recommended Dosage Modification
Grade 1 Corneal Exam Findings: Mild superficial punctate keratopathy*and/or Change in BCVA: Decline from baseline of 1 line on Snellen Equivalent BCVA Continue treatment at current dosage.
Grade 2 Corneal Exam Findings: Moderate superficial punctate keratopathy, patchy microcyst-like deposits†, peripheral sub-epithelial haze, or a new peripheral stromal opacityand/or Change in BCVA: Decline from baseline of 2 lines on Snellen Equivalent BCVA and not worse than 20/200 Withhold BLENREP until improvement in both corneal exam findings and change in BCVA to Grade 1 or less. Resume treatment at Reduced Dosage Level 1. If recurrent Grade 2 or 3 ocular toxicity is experienced, resume treatment at Reduced Dosage Level 2.
Grade 3 Corneal Exam Findings: Severe superficial punctate keratopathy, diffuse microcyst-like deposits† involving the central cornea, central sub-epithelial haze, or a new central stromal opacity and/or Change in BCVA: Decline from baseline of 3 or more lines on Snellen Equivalent BCVA and not worse than 20/200
Grade 4 Corneal Exam Findings: Corneal epithelial defect or corneal ulcer, with or without infection and/or Change in BCVA: Decline to Snellen Equivalent BCVA of worse than 20/200 Consider permanent discontinuation of BLENREP. If continuing treatment, withhold BLENREP until improvement in both corneal exam findings and change in BCVA to Grade 1 or less. For patients previously on 2.5 mg/kg every 3 weeks, resume treatment at Reduced Dosage Level 1. For patients previously on 1.9 mg/kg every 3 weeks, resume treatment at Reduced Dosage Level 2. If recurrent Grade 4 ocular toxicity is experienced, permanently discontinue BLENREP.

* Mild superficial keratopathy (documented worsening from baseline). Refer to Table 3 in the USPI for recommended dosage modifications for other ocular adverse reactions.1

† Microcyst‑like deposits are considered at least a Grade 2 finding. Withhold BLENREP if any microcyst‑like deposits are observed.1

 

 

Dosage modifications for other adverse reactions1*

Adverse Reaction Severity Recommended Dosage Modifications
Thrombocytopenia Platelet count between 25,000/mcL and 50,000/mcL without bleeding For patients on 2.5 mg/kg, reduce to Reduced Dosage Level 1.† For patients on 1.9 mg/kg, continue at same dosage.
Platelet count between 25,000/mcL and 50,000/mcL with bleeding Withhold BLENREP until bleeding resolves. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1. For patients on 1.9 mg/kg, resume at same dosage.
Platelet count less than 25,000/mcL Withhold BLENREP until platelet count recovers to 25,000/mcL or higher. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1. For patients on 1.9 mg/kg, resume at same dosage.
Infusion-related Reactions Grade 2 Interrupt infusion and provide supportive care. Once symptoms resolve to Grade 1 or less, resume infusion at 50% of the initial rate prior to the event. Consider premedication for subsequent infusions.
Grade 3 Interrupt infusion and provide supportive care. Once symptoms resolve to Grade 1 or less, resume at 50% of the initial rate prior to the event. Administer premedication for subsequent infusions.
Grade 4 Permanently discontinue BLENREP. If anaphylactic or life-threatening infusion reaction, permanently discontinue the infusion and institute appropriate emergency care.
Other Adverse Reactions Grade 3 Withhold BLENREP until adverse reaction improves to Grade 1 or less. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1. For patients on 1.9 mg/kg, resume at same dosage.
Grade 4 Consider permanent discontinuation of BLENREP. If continuing treatment, withhold BLENREP until adverse reaction improves to Grade 1 or less. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1. For patients on 1.9 mg/kg, resume at same dosage.

* Adverse reactions were graded according to the Common Terminology Criteria for Adverse Events v5.0.1

† Consider reverting to previous dose, if appropriate once platelet count recovers to 50,000/mcL or higher.1

Patients' last response during first extended dosage interruption2-4*†

Patients’ response prior to and during first extended dosage interruption (>9 weeks)


LIMITATIONS:

  • Data do not include a comparator arm
  • During the dosage interruption, patients continued on the other products within the combination
  • The data presented are based on a post hoc analysis of a subgroup (N=108; n=54) that was exploratory and not adjusted for multiplicity nor powered to detect a statistical difference

In a post hoc analysis of DREAMM-7 median follow-up of 28.2 months (range: 0.1–40.0 months), and a data cutoff on Oct 2, 20232,3

DREAMM-7 post hoc analysis graphic.

* Percentages were rounded so the total adds up to 100%.3

† Last is defined as final observed clinical response.

‡ Response category was maintained or deepened; patients in a CR/sCR response category maintained a response of ≥VGPR.3

§ Defined as patients who moved from a higher response category to a PR.3

|| Developed progressive disease.3

Not evaluable as the response assessment was not available or incomplete.3

Find resources for your patients and your practice

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Learn about the safety profile for BLENREP

SEE SAFETY DATA

Learn about ocular toxicity

OCULAR toxicity

BCVA=Best-Corrected Visual Acuity; BVd=BLENREP (B) + bortezomib (V) + dexamethasone (d); DVd=daratumumab (D) + bortezomib (V) + dexamethasone (d); CTCAE=Common Terminology Criteria for Adverse Events; PR=partial response; Q3W=every 3 weeks; Q8W=every 8 weeks; REMS=Risk Evaluation and Mitigation Strategies; sCR=stringent complete response; Vd=bortezomib (V) + dexamethasone (d); VGPR=very good partial response.

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):393-407. doi:10.1056/NEJMoa2405090

  3. Hájek R, Dimopoulos MA, Hungria V, et al. Characterization of ophthalmic examination findings (OEFs) and impact on reading and driving in patients with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin (belamaf). Presented at: EHA 2025; June 12-15, 2025; Milan, Italy. Poster PS1761.

  4. Data on file, GSK.

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