Safety data
Adverse reactions
BLENREP had a well-established safety profile that was generally well tolerated
Most common adverse reactions (≥20%) in patients from DREAMM-7
Non-ophthalmic examination findings toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
*Based on ophthalmic examination findings.
†Included thrombocytopenia and decreased platelet count.
‡Included anemia, hemoglobin decreased, iron deficiency anemia, macrocytic anemia, and red blood cell decreased.
§Based on the MedDRA SMQ Infective pneumonia (narrow).
‖Included fatigue, asthenia and malaise.
BCVA: Best corrected visual acuity; BVd: BLENREP + bortezomib and dexamethasone; DVd: Daratumumab + bortezomib and dexamethasone.
BLENREP had a well-established safety profile that was generally well tolerated
Most common adverse reactions (≥20%) in patients from DREAMM-8
Non-ophthalmic examination findings toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
*Based on ophthalmic examination findings.
†Included neutropenia and decreased neutrophil count.
‡Included thrombocytopenia and decreased platelet count.
§Included anemia, macrocytic anemia, iron deficiency anemia, decreased hemoglobin and decreased red blood cell count.
‖Based on the MedDRA SMQ Infective pneumonia (narrow).
¶Included fatigue, asthenia and malaise.
BCVA: Best corrected visual acuity; BPd: BLENREP + pomalidomide and dexamethasone; PVd: Pomalidomide + bortezomib and dexamethasone.
Eye-related side effects
Summary of BLENREP-associated eye-related side effects in DREAMM-7
*Resolution of ocular adverse reactions was defined as being free from any ocular adverse reactions.
†Events reflect bilateral worsening of BCVA.
‡Resolution of visual acuity was defined as 20/25 or better in at least one eye.
§Resolution of corneal examination findings was defined as Grade 1 or better based on the ophthalmic examination findings.
‖At the time of data cut-off (October 7, 2024).
ERSE: Eye-related side effects.
Summary of changes in best corrected visual acuity in patients treated with BLENREP + Vd1
See what each vision change could look like
Of the patients with a 20/50 BCVA or worse, 93% (78/84) experienced resolution of the first event.1* The median time to resolution of the first event was 63.5 days.1
Of the patients with a BCVA of 20/200 or worse, 80% (4/5) experienced resolution of the first event.1* The median time to resolution of the first event was 86.5 days.1
Images are for illustrative purposes only. Vision will differ for each individual. Images created with an ECP using methodology derived from Hunt & Bassi applying defined Gaussian blur and pixelation. Vision impairment simulation via Adobe Photoshop through application of a fixed Gaussian blur level: 20/20 0.5 pixels; 20/50 4.0 pixels; 20/200 15 pixels.2
Eye-related side effects can be managed with appropriate dose modifications and follow-up.1
*Resolution of visual acuity was defined as 20/25 or better in at least one eye.
†Improved to better than bilateral 20/200.
Summary of BLENREP-associated eye-related side effects in DREAMM-8
*Resolution of ocular adverse reactions was defined as being free from any ocular adverse reactions.
†Events reflect bilateral worsening of BCVA.
‡Resolution of visual acuity was defined as 20/25 or better in at least one eye.
§Resolution of corneal examination findings was defined as Grade 1 or better based on the ophthalmic examination findings.
‖At the time of data cut-off (October 7, 2024).
ERSE: Eye-related side effects.
Summary of changes in best corrected visual acuity in patients treated with BLENREP + Pd1
See what each vision change could look like
Of the patients with a 20/50 BCVA or worse, 88% (45/51) experienced resolution of the first event.1* The median time to resolution of the first event was 57 days.1
Of the patients with a BCVA of 20/200 or worse, 80% (4/5) experienced resolution of the first event.1* The median time to resolution of the first event was 86.5 days.1
Images are for illustrative purposes only. Vision will differ for each individual. Images created with an ECP using methodology derived from Hunt & Bassi applying defined Gaussian blur and pixelation. Vision impairment simulation via Adobe Photoshop through application of a fixed Gaussian blur level: 20/20 0.5 pixels; 20/50 4.0 pixels; 20/200 15 pixels.2
Eye-related side effects can be managed with appropriate dose modifications and follow-up.1
*Resolution of visual acuity was defined as 20/25 or better in at least one eye.
†Improved to better than bilateral 20/200.
Eye care management
Guidance to help manage eye-related side effects
Advise patients on the following strategies to help manage eye-related side effects:
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Administer preservative-free artificial tears at least 4 times a day, beginning on the first day of infusion and continuing until completion of treatment. This may help with eye-related symptoms. For patients with dry eye symptoms, additional therapies may be recommended by eye care professionals.
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Avoid contact lenses until the end of treatment.
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If vision changes are experienced, refrain from driving or operating machinery until evaluated by an eye care professional.
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Contact their care team promptly if they experience any eye-related symptoms.
ERSE: Eye-related side effects.