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Adverse event reporting can be found at the bottom of the page
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The content of this website has been produced in line with the ELREXFIO®▼ (elranatamab) Summary of Product Characteristics. For Elrexfio®▼ (elranatamab) Prescribing Information for United Kingdom click here.
The safety database of ELREXFIO® includes 183 adult patients from the MagnetisMM-3 study, who received the recommended ELREXFIO® dosing regimen as monotherapy for multiple myeloma.1
The MagnetisMM-3 study included patients who were refractory to at least one proteasome inhibitor, one immunomodulatory again and one anti-CD38 monoclonal antibody. These patients were either naive to prior BCMA-directed therapy (cohort A) OR had received prior BCMA-directed therapy or chimeric antigen receptor (CAR) T-cell therapy (cohort B). The median duration of treatment was 4.1 months (range: 0.03 to 20.3 months).1
| System organ class | Adverse reaction | Frequency* (All grades) |
n=183 | |
|---|---|---|---|---|
| Any grade, n (%) | Grade 3 or 4, n (%) | |||
| Infections and infestations | Pneumoniaa | Very common | 68 (37.2) | 45 (24.6) |
| Sepsisb | Very common | 33 (18.0) | 23 (12.6) |
|
| Upper respiratory tract infection | Very common | 71 (38.8) |
10 (5.5) |
|
| Urinary tract infection | Very common | 23 (12.6) |
8 (4.4) |
|
| Cytomegalovirus infection (CMV)c | Common | 17 (9.3) |
4 (2.2) |
|
| Blood and lymphatic system disorders | Neutropenia | Very common | 82 (44.8) |
79 (43.2) |
| Anaemia | Very common | 99 (54.1) |
78 (42.6) |
|
| Thrombocytopenia | Very common | 66 (36.1) |
48 (26.2) |
|
| Lymphopenia | Very common | 55 (30.1) |
51 (27.9) |
|
| Leukopenia | Very common | 32 (17.5) |
23 (12.6) |
|
| Febrile neutropenia | Common | 5 (2.7) |
5 (2.7) |
|
| Immune system disorders | Cytokine release syndrome | Very common | 106 (57.9) |
1 (0.5) |
| Hypogammaglobulinaemia | Very common | 26 (14.2) |
5 (2.7) |
|
| Metabolism and nutrition disorders | Decreased appetite | Very common | 49 (26.8) |
2 (1.1) |
| Hypokalaemia | Very common | 42 (23.0) |
16 (8.7) |
|
| Hypophosphataemia | Common | 12 (6.6) |
1 (0.5) |
|
| Nervous system disorders | Peripheral neuropathyd | Very common | 29 (15.8) |
2 (1.1) |
| Headache | Very common | 35 (19.1) |
0 (0) |
|
| Immune effector cell-associated neurotoxicity syndrome | Common | 6 (3.3) |
2 (1.1) |
|
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | Very common | 35 (19.1) |
9 (4.9) |
| Gastrointestinal disorders | Diarrhoea | Very common | 69 (37.7) |
2 (1.1) |
| Nausea | Very common | 39 (21.3) |
0 (0) |
|
| Skin and subcutaneous tissue disorders | Rashe | Very common | 48 (26.2) |
0 (0) |
| Dry skin | Very common | 39 (21.3) |
0 (0) |
|
| Musculoskeletal and connective tissue disorders | Arthralgia | Very common | 46 (25.1) |
3 (1.6) |
| General disorders and administration site conditions | Injection site reaction | Very common | 70 (38.3) |
0 (0) |
| Pyrexia | Very common | 50 (27.3) |
6 (3.3) |
|
| Fatigue | Very common | 81 (44.3) |
11 (6.0) |
|
| Investigations | Transaminases increased | Very common | 31 (16.9) |
10 (5.5) |
Adapted from ELREXFIO® SmPC; Pfizer Ltd. Data on File. REF-E1A2147; Pfizer Ltd. Data on File. REF-E1A2145; Pfizer Ltd. Data on File. REF-L1A1045.1-4
Data cut off: 16 April 2023 (median duration of follow-up was 15.2 months).
*Adverse reactions are listed according to the MedDRA system organ classification and by frequency. Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).1
a. Pneumonia includes pneumonia, COVID-19 pneumonia, bronchopulmonary aspergillosis, lower respiratory tract infection bacterial, lower respiratory tract infection viral, pneumocystis jirovecii pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia. cytomegaloviral, pneumonia fungal, pneumonia influenzal, pneumonia pseudomonal, pneumonia viral, atypical pneumonia, coronavirus pneumonia, pneumonia haemophilus, pneumonia pneumococcal, pneumonia respiratory syncytial viral.
b. Sepsis includes sepsis, bacteraemia, device related bacteraemia, device related sepsis, escherichia bacteraemia, escherichia sepsis, klebsiella sepsis, pseudomonal sepsis, septic shock, staphylococcal bacteraemia, staphylococcal sepsis, streptococcal sepsis, urosepsis, campylobacter bacteraemia.
c. CMV includes cytomegalovirus infection reactivation, cytomegalovirus infection, cytomegalovirus chorioretinitis, cytomegalovirus gastroenteritis, cytomegalovirus viraemia.
d. Peripheral neuropathy includes peripheral sensory neuropathy, paraesthesia, peripheral sensorimotor neuropathy, dysaesthesia, neuropathy peripheral, peripheral motor neuropathy, Guillain-Barre syndrome, hypoaesthesia, neuralgia, polyneuropathy.
e. Rash incudes dermatitis exfoliative, dermatitis exfoliative generalised, erythema, palmar-plantar erythrodysaesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash pustular, symmetrical drug-related intertriginous and flexural exanthema, epidermolysis.
57.9% of patients (n=106) receiving ELREXFIO® at the recommended dose in the MagnetisMM-3 trial (n=183) experienced CRS of any grade.1,5
CRS events were manageable and resolved with appropriate interventions. Among patients who experienced CRS (n=106):1,5
Adapted from ELREXFIO® SmPC.1
Please refer to the ELREXFIO® SmPC for full symptom monitoring and early intervention information for CRS.
In patients receiving ELREXFIO® at the recommended dose in the MagnetisMM-3 trial (n=183):1,6
Please refer to the ELREXFIO® SmPC for full symptom monitoring and early intervention information for ICANS.
BCMA: B-cell maturation antigen; CAR: chimeric antigen receptor; CD38: cluster of differentiation 38; CRS: cytokine release syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; SmPC: Summary of Product Characteristics
References:
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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