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BLENREP is indicated in adults for the treatment of multiple myeloma:1
- In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
- In combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide
Special warnings
BLENREP starting doses in combination with bortezomib and dexamethasone (Vd) or pomalidomide and dexamethasone (Pd). In the event of side effects, BLENREP dosing can be reduced or delayed.
Adapted from BLENREP Summary of Product Characteristics.
Please refer to the SPC for full dosing guidance before prescribing.
*Please see SPC for dose adjustments in thrombocytopenia with or without active bleeding.1 †For grade 4 ERSEs, BLENREP in combination with pomalidomide and dexamethasone can be restarted at a reduced dose of 1.4 mg/kg Q8W.1
Grade 4 adverse events may require permanent discontinuation of BLENREP.1
For a full overview of all of the side effects, please visit the efficacy and safety page of each clinical trial for BLENREP and Vd or BLENREP and Pd
Discontinuation rate of any component therapy in the DREAMM-7 study was 31%, and in the DREAMM-8 study it was 15%.
Dose modifications for eye-related side effects*1
Patients should have ophthalmic assessments prior to the first 4 doses and as clinically indicated thereafter, please see the SPC for further information.1 Recommended dose modifications for eye-related side effects are based on both corneal examination findings and/or changes in best corrected visual acuity (BCVA).1 The recommended dose modification of BLENREP should be based on the results from the most severely affected eye, as both eyes may not be affected to the same degree.1
Do not re-escalate BLENREP after a dose reduction is made for eye-related side effects.1
| Corneal exam findings | Change in BCVA | Recommended dose changes | |
|---|---|---|---|
| Grade 1 | Mild superficial punctate keratopathy with worsening from baseline, with or without symptoms | Decline from baseline of 1 line on Snellen Equivalent Visual Acuity | Continue treatment at current dose |
| Grade 2 | Moderate superficial punctate keratopathy, patchy microcyst-like deposits, peripheral sub-epithelial haze, or a new peripheral stromal opacity | Decline from baseline of 2 lines (and Snellen Equivalent Visual Acuity not worse than 20/200) | Withhold treatment until improvement in both corneal examination findings and BCVA to Grade 1 or better. Resume treatment at reduced level:
|
| Grade 3 | Severe superficial punctate keratopathy, diffuse microcyst-like deposits involving the central cornea, central sub-epithelial haze, or a new central stromal opacity | Decline from baseline of 3 or more lines (and Snellen Equivalent Visual Acuity not worse than 20/200) | Withhold treatment until improvement in both corneal examination findings and BCVA to Grade 1 or better. Resume treatment at reduced level.
|
| Grade 4 | Corneal epithelial defect A corneal defect may lead to corneal ulcers. These should be managed promptly and as clinically indicated by an eye care professional |
Decline to Snellen Equivalent Visual Acuity of worse than 20/200 | Withhold until improvement in both corneal examination findings and BCVA to Grade 1 or better. Resume treatment at:
For worsening symptoms that are unresponsive to dose reduction or withholding of treatment, consider permanent discontinuation. |
*Eye-related side effect severity is defined by the most severely affected eye, as both eyes may not be affected to the same degree. An eye care professional will determine the severity of corneal exam findings. †If toxicity is identified prior to dosing Cycle 2 for BLENREP with pomalidomide and dexamethasone, dose at 1.9 mg/kg every 4 weeks.
Thrombocytopenia*1
Please see the table below for the recommended dose modifications in the event of thrombocytopenia side effects.
| Recommended dose modification | |
|---|---|
| Grade 3 | No bleeding With bleeding Consider additional supportive treatment (e.g. transfusion), as clinically indicated and per local practice. |
| Grade 4 | Withhold the dose. Consider restarting if recovered to Grade 3 or better, and only if there is no active bleeding at time of treatment restart. For patients previously on 2.5 mg/kg, resume BLENREP at 1.9 mg/kg. For patients on 1.9 mg/kg or lower, resume at same dose.
|
*Other adverse reactions were graded according to the National Cancer Institute CTCAE. †For BVd, consider reverting to previous dose if appropriate once thrombocytopenia recovers to Grade 2 or better.
Patients with Grade 1 or 2 thrombocytopenia can continue to receive BLENREP if clinically appropriate1
Infusion-related reactions*1
Please see the table below for the recommended dose modifications in the event of IRRs side effects.
| Recommended dose modification | |
|---|---|
| Grade 2 | Interrupt infusion and provide supportive treatment. Once symptoms resolve to Grade 1 or better, resume at a decreased infusion rate by at least 50%. |
| Grade 3 | Interrupt infusion and provide supportive treatment. Once symptoms resolve to Grade 1 or better, resume with premedication and at lower infusion rate extended to 2 to 4 hours. Any future infusion requires premedication. |
| Grade 4 |
Permanently discontinue BLENREP.
|
*Other adverse reactions were graded according to the National Cancer Institute CTCAE.
With BLENREP, there is no SPC-mandated premedication; however, if a patient experiences a Grade 3 or above infusion-related reaction, future doses require premedication1
Other side effects*1
Please see the table below for the recommended dose modifications in the event of other side effects.
| Recommended dose modification | |
|---|---|
| Grade 3 | Withhold BLENREP until improvement to Grade 1 or better. For patients previously on 2.5 mg/kg, resume BLENREP at 1.9 mg/kg. For patients on 1.9 mg/kg or lower, resume at same dose. |
| Grade 4 | Consider permanent discontinuation of BLENREP.
|
*Other adverse reactions were graded according to the National Cancer Institute CTCAE.
Dose exposure in DREAMM-7 and DREAMM-8
Dose exposure of BLENREP in DREAMM-71,4
| Dose exposure of BLENREP in DREAMM-71,4 | 0 to ≤6 Months (n=242) |
>6 to ≤12 Months (n=162) |
>12 Months (n=132) |
Overall (N=242) |
|
|---|---|---|---|---|---|
| Total number of doses | n | 1133 | 577 | 1122 | 2832 |
| Number of doses administered by dose level (%) | 2.5 mg/kg | 768 (68) | 198 (34) | 201 (18) | 1167 (41) |
| 1.9 mg/kg | 365 (32) | 379 (66) | 921 (82) | 1665 (59) | |
| Time between doses per patient | n | 231 | 130 | 124 | 231 |
| Mean, weeks | 4.8 | 6.8 | 10.9 | 7.2 | |
| Median (IQR), weeks | 3.6 (3–6) | 4.7 (3–8) | 9.5 (5–15) | 5.7 (3–10) | |
- Side effects leading to dose delays of any component of therapy occurred in 94% of patients in DREAMM-71
- The median time between doses after 12 months was 9.5 weeks in DREAMM-71
Please refer to the SPC for dose recommendations.
Dose exposure of BLENREP in DREAMM-81,5
| Dose exposure of BLENREP in DREAMM-81,5 | 0 to ≤6 Months (n=150) |
>6 to ≤12 Months (n=104) |
>12 Months (n=77) |
Overall (N=150) |
|
|---|---|---|---|---|---|
| Total number of doses | n | 570 | 242 | 286 | 1098 |
| Number of doses administered by dose level (%) | 2.5 mg/kg | 151 (26) | - | - | 151 (14) |
| 1.9 mg/kg | 415 (73) | 235 (97) | 267 (93) | 917 (84) | |
| 1.4 mg/kg | 4 (<1) | 7 (3) | 19 (7) | 30 (3) | |
| Time between doses per patient | n | 129 | 79 | 77 | 142 |
| Mean, weeks | 5.26 | 11.91 | 14.2 | 9.46 | |
| Median (IQR), weeks |
4.1 (4–5) | 11.8 (5–16) | 14.1 (10–18) | 8.7 (5–13) | |
- Side effects leading to dose delays of any component of therapy occurred in 91% of patients in DREAMM-81
- The median time between doses after 12 months was 14.1 weeks in DREAMM-81
Dose modifications included in these tables were due to eye-related side effects and non-eye-related side effects. Please refer to the SPC for dose recommendations.
Extended dose delays
In DREAMM-7 and DREAMM-8, the primary endpoint was progression-free survival, which was met in both trials.6,7
Post hoc analyses:
No statistical testing performed
In DREAMM-7 and DREAMM-8 trials, dose delays were frequent in response to adverse events. Amongst patients who had extended dose delays (>12 weeks), the mPFS was numerically equivalent to the ITT population.4–7
Please refer to the SPC for dose modification guidance.
| mPFS (95% CI), months | ||||
|---|---|---|---|---|
| ITT population | Patient with ≥1 dose delay of ≥12 weeks* | |||
| DREAMM-7 | n=243 | 36.6 (28.4–NR) | n=126 | 36.6 (33.2–NR) |
| mPFS (95% CI), months | ||||
|---|---|---|---|---|
| ITT population | Patient with ≥1 dose delay of ≥12 weeks* | |||
| DREAMM-8 | n=155 | NR (20.6–NR) | n=93 | NR (NR–NR) |
*Only patients receiving ≥6 months of treatment were included in the analysis to exclude early discontinuations (e.g. rapid PD).
BLENREP is not recommended in pregnancy or breastfeeding.1
Women of child-bearing potential must use effective contraception during treatment and for at least 4 months after.1
Males with female partners of child-bearing potential must use effective contraception during treatment and for at least 6 months after.1
BLENREP is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.1
Haematologists should collaborate with eye care professionals to help monitor and manage eye-related side effects.1
Abbreviations
2L, second line; BCVA, best corrected visual acuity; BPd, belantamab mafodotin, pomalidomide and dexamethasone; BVd, belantamab mafodotin, bortezomib and dexamethasone; CI, confidence interval; CTCAE, Common Terminology Criteria for Adverse Events; ERSE, eye-related side effect; HBV, hepatitis B virus; IQR, interquartile range; IRR, infusion-related reaction; ITT, intention-to-treat; MDT: multidisciplinary team; mPFS, median progression-free survival; NR, not reached; PD, progressive disease; Pd, pomalidomide and dexamethasone; Q3W, every 3 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; SPC, Summary of Product Characteristics; Vd, bortezomib and dexamethasone.
References
- BLENREP. Summary of Product Characteristics. GlaxoSmithKline; 2025.
- Yang Y, Zhao B, Lan H, et al. Bortezomib-induced peripheral neuropathy: Clinical features, molecular basis, and therapeutic approach. Critical Reviews in Oncology/Hematology 2024;197:104353.
- Dimopoulos MA, Leleu X, Moreau P, et al. Expert panel consensus statement on the optimal use of Pomalidomide in relapsed and refractory multiple myeloma. Leukemia 2014;28:1573–1585.
- Hungria V, Robak P, Hus M, et al. Characterization and management of ocular events in patients treated with belantamab mafodotin plus bortezomib and dexamethasone in the DREAMM-7 Study. Presented at 2024 IMS Annual Meeting. 28–29 September. Rio de Janeiro, Brazil.
- Quach H, Dimopoulos MA, Beksac M, et al. Characterization and management of ocular events in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone in the DREAMM-8 study. Presented at 2024 IMS Annual Meeting. 28–29 September. Rio de Janeiro, Brazil.
- 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.
- Dimopoulos MA, Beksac M, Pour L, et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med 2024;391(5):408–421.
▼This product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (available on the Apple App Store or Google Play Store). Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or UKSafety@GSK.com.
October 2025 | PM-GB-BLM-WCNT-250028 (V1.0)
