SAFETY

MINJUVI^® PLUS LENALIDOMIDE – A GENERALLY MANAGEABLE SAFETY PROFILE^1-3

General safety information¹

MOST COMMON ADVERSE REACTIONS	% OF POPULATION (N=81)
Infections	73
Neutropenia	51
Asthenia	38
Anaemia	36
Diarrhoea	36
Thrombocytopenia	31
Cough	26
Peripheral oedema	24
Pyrexia	24
Decreased appetite	22

The most common serious adverse events (SAEs) were infection (26%), including pneumonia (7%) and febrile neutropenia (6%)¹
Permanent discontinuation of MINJUVI^® due to an adverse reaction occurred in 15% of patients¹
- The most common adverse reactions leading to permanent discontinuation of MINJUVI^® were infections and infestations (5%), nervous system disorders (2.5%), and respiratory, thoracic and mediastinal disorders (2.5%)

See SmPC/UK PI/ROI PI for further safety information

MINJUVI^® DEMONSTRATED A GENERALLY MANAGEABLE SAFETY PROFILE AT A MEDIAN FOLLOW UP OF 42.7 MONTHS^1-3

L-MIND confirmed MINJUVI^® plus lenalidomide to be well tolerated by patients with transplant ineligible R/R DLBCL,⁴ including in elderly patients and those with co-morbidities⁵
Overall, MINJUVI^® plus lenalidomide was well tolerated in long-term, three-year follow up of the L-MIND study, and no unexpected toxicities or new safety signals arose³
- Treatment-emergent AEs (TEAEs) were consistent in incidence and severity at later follow up versus primary analysis outcomes*³
The adverse event (AE) burden decreased when patients continued from a combination of MINJUVI^® and lenalidomide to MINJUVI^® monotherapy**³

TEAEs (any Grade) by patient years of exposure to MINJUVI^® plus lenalidomide and MINJUVI^® monotherapy*³

MINJUVI^® plus lenalidomide AE/patient year		Extended MINJUVI^® monotherapy AE/patient year

Adapted from Duell J, et al. 2021.³
*Follow up 42.7 months vs. 19.6 months; **Safety analysis set (n=81), median duration of exposure to MINJUVI^® or lenalidomide 9.2 months.

Serious TEAEs† were reported in 43 patients (53.1%)³
- The most common SAEs were pneumonia (seven patients [8.6%]), febrile neutropenia (five patients [6.2%]), pulmonary embolism (three patients [3.7%]), bronchitis, lower respiratory tract infection, atrial fibrillation and congestive cardiac failure (all of which occurred in two patients [2.5%])³
- The most common Grade ≥3 TEAEs were neutropenia (49%), thrombocytopenia (17%) and febrile neutropenia (12.3%)³
In the 10 patients (12.3%) that experienced febrile neutropenia (Grade 3 or 4), five patients developed no infections at all or their timing was not associated with febrile neutropenia³
During the study, the incidence of infusion-related reactions was low. All cases were Grade 1³
The most frequent TEAE leading to treatment interruption for tafasitamab (± lenalidomide) and lenalidomide (± tafasitamab) therapy was neutropenia (28 [34.6%] patients and 24 [29.6%] patients, respectively)³
- During the monotherapy phase, 21 (52.5%) patients had an interruption of treatment due to at least one TEAE, the most common reasons being neutropenia or leukopenia (nine patients) and respiratory tract infections (six patients)³

†Treatment-emergent AEs include both treatment-related and non-treatment-related AEs not present prior to starting therapy.

References:

MINJUVI (tafasitamab) SPC. May 2022. https://www.medicines.org.uk/emc/product/13003/smpc. Last accessed, January 2025.
MINJUVI (tafasitamab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdf. Last accessed, January 2024.
Duell J, et al. Haematologica 2021; 106.
Salles G, et al. Lancet Oncol 2020; 21(7): 978–88.
Duell J, et al. American Society of Hematology (ASH) Orlando, Florida, USA. December 7, 2019. #1582

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Adverse events in the UK should be reported.

Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to Incyte by calling 00‑800‑0002‑7423

Adverse events in ROI should be reported.

Reporting forms and information can be found at HPRA Pharmacovigilance: www.hpra.ie

Adverse events should also be reported to Incyte immediately by phoning the Toll-free phone number 1800456748

AE, adverse event; DLBCL, diffuse large B-cell lymphoma; SAE, serious adverse event; TEAE, treatment-emergent adverse event; R/R, relapsed/refractory; SmPC, Summary of Product Characteristics; 2L, second line

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MINJUVI® PLUS LENALIDOMIDE – A GENERALLY MANAGEABLE SAFETY PROFILE1-3

General safety information1

MINJUVI® DEMONSTRATED A GENERALLY MANAGEABLE SAFETY PROFILE AT A MEDIAN FOLLOW UP OF 42.7 MONTHS1-3

TEAEs (any Grade) by patient years of exposure to MINJUVI® plus lenalidomide and MINJUVI® monotherapy*3

MINJUVI® PLUS LENALIDOMIDE: CAPTURES THE POTENTIAL FOR ANTI-TUMOUR RESPONSES IN A GENERALLY WELL-TOLERATED TREATMENT FOR R/R DLBCL, 2L AND BEYOND3,4

References:

MINJUVI^® PLUS LENALIDOMIDE – A GENERALLY MANAGEABLE SAFETY PROFILE^1-3

General safety information¹

MINJUVI^® DEMONSTRATED A GENERALLY MANAGEABLE SAFETY PROFILE AT A MEDIAN FOLLOW UP OF 42.7 MONTHS^1-3

TEAEs (any Grade) by patient years of exposure to MINJUVI^® plus lenalidomide and MINJUVI^® monotherapy*³

MINJUVI^® PLUS LENALIDOMIDE: CAPTURES THE POTENTIAL FOR ANTI-TUMOUR RESPONSES IN A GENERALLY WELL-TOLERATED TREATMENT FOR R/R DLBCL, 2L AND BEYOND^3,4