ELREXFIO Adverse Reactions

(elranatamab-bcmm)

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in labeling:

•
Cytokine Release Syndrome [see Warnings and Precautions (5.1)].
•
Neurologic Toxicity, Including ICANS [see Warnings and Precautions (5.2)].
•
Infections [see Warnings and Precautions (5.4)].
•
Neutropenia [see Warnings and Precautions (5.5)].
•
Hepatotoxicity [see Warnings and Precautions (5.6)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Relapsed/Refractory Multiple Myeloma

MagnetisMM-3

The safety of ELREXFIO was evaluated in MagnetisMM-3 [see Clinical Studies (14)]. The safety population described (n = 183) includes patients who received the recommended dosage regimen of 12 mg subcutaneously on Day 1, 32 mg on Day 4, and 76 mg once weekly starting on Day 8. Among patients who received ELREXFIO, 42% were exposed for 6 months or longer and 9% were exposed for one year or longer.

The median age of patients who received ELREXFIO was 68 years (range: 36 to 88 years); 48% were female; 61% were White, 10% were Hispanic/Latino, 9% were Asian, and 6% were Black or African American.

Serious adverse reactions occurred in 68% of patients who received ELREXFIO at the recommended dosing schedule. Serious adverse reactions in >2% of patients included pneumonia (25%), sepsis (13%), CRS (13%), upper respiratory tract infection (4.4%), acute kidney injury (3.8%), urinary tract infection (3.3%), COVID-19 (3.3%), encephalopathy (3.3%), pyrexia (2.2%), and febrile neutropenia (2.2%). Fatal adverse reactions occurred in 10% of patients including pneumonia (3.3%), sepsis (2.7%), acute respiratory distress syndrome (0.5%), cardio-respiratory arrest (0.5%), cardiogenic shock (0.5%), cardiopulmonary failure (0.5%), COVID-19 (0.5%), failure to thrive (0.5%), and pulmonary embolism (0.5%).

Permanent discontinuations of ELREXFIO due to an adverse reaction occurred in 17% of patients. Adverse reactions which resulted in permanent discontinuation of ELREXFIO in >2% of patients included septic shock (2.2%).

Dosage interruptions of ELREXFIO due to an adverse reaction occurred in 73% of patients. Adverse reactions which resulted in dose interruptions of ELREXFIO in >5% of patients included neutropenia, pneumonia, COVID-19, upper respiratory tract infection, thrombocytopenia, and anemia.

The most common adverse reactions (≥20%) were CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia. The most common Grade 3 to 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Table 8 summarizes adverse reactions in MagnetisMM-3.

Table 8. Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Multiple Myeloma Who Received ELREXFIO in MagnetisMM-3
Adverse reactions were graded based on CTCAE Version 5.0, with the exception of CRS, which was graded based on the ASTCT 2019 criteria.
*
Only grade 3 adverse reactions occurred.
†
Includes other related terms.
‡
Pneumonia includes COVID-19 pneumonia, lower respiratory tract infection, lower respiratory tract infection viral, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia fungal, pneumonia influenzal, pneumonia pseudomonal, pneumonia viral.
§
Sepsis includes bacteremia, device related bacteremia, device related sepsis, escherichia bacteremia, escherichia sepsis, klebsiella sepsis, pseudomonal sepsis, sepsis, septic shock, staphylococcal bacteremia, staphylococcal sepsis, streptococcal sepsis, urosepsis.
Rash incudes erythema, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash pustular, symmetrical drug-related intertriginous and flexural exanthema.
#
Encephalopathy includes agitation, altered state of consciousness, cognitive disorder, confusional state, delirium, depressed level of consciousness, disorientation, hallucination, lethargy, memory impairment, mental status changes, metabolic encephalopathy, somnolence, toxic encephalopathy.
Þ
Sensory neuropathy includes burning sensation, dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, parosmia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, sensory loss.
ß
Motor dysfunction includes ataxia, balance disorder, gait disturbance, motor dysfunction, muscle contracture, muscle spasms, muscular weakness, peripheral motor neuropathy, peroneal nerve palsy, tremor.

System Organ Class

Preferred Term

ELREXFIO

N = 183

All Grades

(%)

Grade 3 or 4

(%)

Immune system disorders

Cytokine release syndrome

58

0.5*

Hypogammaglobulinemia†

13

2.2*

General disorders and site administration conditions

Fatigue†

43

6*

Injection site reaction†

37

0

Pyrexia

21

2.7*

Edema†

18

1.1*

Gastrointestinal disorders

Diarrhea

36

1.1*

Nausea

22

0

Constipation

15

0

Vomiting

14

0

Infections

Upper respiratory tract infection†

34

4.9

Pneumonia‡

32

19

Sepsis§

15

11

Urinary tract infection†

12

4.4*

Musculoskeletal and connective tissue disorders

Musculoskeletal pain†

34

2.7*

Metabolism and nutrition disorders

Decreased appetite

26

1.1*

Skin and Subcutaneous Tissue disorders

Rash

25

0

Dry skin

13

0

Skin exfoliation†

10

0

Respiratory, thoracic and mediastinal disorders

Cough†

24

0

Dyspnea†

15

3.3*

Nervous system disorders

Headache

18

0.5

Encephalopathy#

15

2.7

Sensory neuropathyÞ

13

0.5*

Motor dysfunctionß

13

2.2*

Cardiac disorders

Cardiac arrhythmia†

16

2.2

Vascular disorders

Hemorrhage†

13

1.6

Psychiatric disorders

Insomnia

13

0

Injury, poisoning and procedural complications

Fall

10

0.5*

Clinically relevant adverse reactions in <10% of patients who received ELREXFIO included ICANS, febrile neutropenia, Guillain-Barré syndrome, abdominal pain, acute kidney injury, COVID-19, cardiac failure, congestion, and thrombosis.

Table 9 summarizes laboratory abnormalities in MagnetisMM-3.

Table 9. Select Laboratory Abnormalities (≥30%) That Worsened from Baseline in Patients with Relapsed or Refractory Multiple Myeloma Who Received ELREXFIO in MagnetisMM-3*
*
Laboratory tests were graded according to NCI-CTCAE Version 5.0
†
The denominator used to calculate the rate varied from 181 to 183 based on the number of patients with a baseline value and at least one post-treatment value.

Laboratory Abnormality

ELREXFIO†

All Grades (%)

Grade 3 or 4 (%)

Hematology

Lymphocyte count decreased

91

84

White blood cell decreased

69

40

Hemoglobin decreased

68

43

Neutrophil count decreased

62

51

Platelet count decreased

61

32

Chemistry

Albumin decreased

55

6

AST increase

40

6

Creatinine increased

38

3.3

Potassium decreased

36

8

ALT increase

36

3.8

Alkaline phosphatase increased

34

1.1

Creatinine clearance decreased

32

10

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Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in labeling:

•
Cytokine Release Syndrome [see Warnings and Precautions (5.1)].
•
Neurologic Toxicity, Including ICANS [see Warnings and Precautions (5.2)].
•
Infections [see Warnings and Precautions (5.4)].
•
Neutropenia [see Warnings and Precautions (5.5)].
•
Hepatotoxicity [see Warnings and Precautions (5.6)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Relapsed/Refractory Multiple Myeloma

MagnetisMM-3

The safety of ELREXFIO was evaluated in MagnetisMM-3 [see Clinical Studies (14)]. The safety population described (n = 183) includes patients who received the recommended dosage regimen of 12 mg subcutaneously on Day 1, 32 mg on Day 4, and 76 mg once weekly starting on Day 8. Among patients who received ELREXFIO, 42% were exposed for 6 months or longer and 9% were exposed for one year or longer.

The median age of patients who received ELREXFIO was 68 years (range: 36 to 88 years); 48% were female; 61% were White, 10% were Hispanic/Latino, 9% were Asian, and 6% were Black or African American.

Serious adverse reactions occurred in 68% of patients who received ELREXFIO at the recommended dosing schedule. Serious adverse reactions in >2% of patients included pneumonia (25%), sepsis (13%), CRS (13%), upper respiratory tract infection (4.4%), acute kidney injury (3.8%), urinary tract infection (3.3%), COVID-19 (3.3%), encephalopathy (3.3%), pyrexia (2.2%), and febrile neutropenia (2.2%). Fatal adverse reactions occurred in 10% of patients including pneumonia (3.3%), sepsis (2.7%), acute respiratory distress syndrome (0.5%), cardio-respiratory arrest (0.5%), cardiogenic shock (0.5%), cardiopulmonary failure (0.5%), COVID-19 (0.5%), failure to thrive (0.5%), and pulmonary embolism (0.5%).

Permanent discontinuations of ELREXFIO due to an adverse reaction occurred in 17% of patients. Adverse reactions which resulted in permanent discontinuation of ELREXFIO in >2% of patients included septic shock (2.2%).

Dosage interruptions of ELREXFIO due to an adverse reaction occurred in 73% of patients. Adverse reactions which resulted in dose interruptions of ELREXFIO in >5% of patients included neutropenia, pneumonia, COVID-19, upper respiratory tract infection, thrombocytopenia, and anemia.

The most common adverse reactions (≥20%) were CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia. The most common Grade 3 to 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Table 8 summarizes adverse reactions in MagnetisMM-3.

Table 8. Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Multiple Myeloma Who Received ELREXFIO in MagnetisMM-3
Adverse reactions were graded based on CTCAE Version 5.0, with the exception of CRS, which was graded based on the ASTCT 2019 criteria.
*
Only grade 3 adverse reactions occurred.
†
Includes other related terms.
‡
Pneumonia includes COVID-19 pneumonia, lower respiratory tract infection, lower respiratory tract infection viral, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia fungal, pneumonia influenzal, pneumonia pseudomonal, pneumonia viral.
§
Sepsis includes bacteremia, device related bacteremia, device related sepsis, escherichia bacteremia, escherichia sepsis, klebsiella sepsis, pseudomonal sepsis, sepsis, septic shock, staphylococcal bacteremia, staphylococcal sepsis, streptococcal sepsis, urosepsis.
Rash incudes erythema, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash pustular, symmetrical drug-related intertriginous and flexural exanthema.
#
Encephalopathy includes agitation, altered state of consciousness, cognitive disorder, confusional state, delirium, depressed level of consciousness, disorientation, hallucination, lethargy, memory impairment, mental status changes, metabolic encephalopathy, somnolence, toxic encephalopathy.
Þ
Sensory neuropathy includes burning sensation, dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, parosmia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, sensory loss.
ß
Motor dysfunction includes ataxia, balance disorder, gait disturbance, motor dysfunction, muscle contracture, muscle spasms, muscular weakness, peripheral motor neuropathy, peroneal nerve palsy, tremor.

System Organ Class

Preferred Term

ELREXFIO

N = 183

All Grades

(%)

Grade 3 or 4

(%)

Immune system disorders

Cytokine release syndrome

58

0.5*

Hypogammaglobulinemia†

13

2.2*

General disorders and site administration conditions

Fatigue†

43

6*

Injection site reaction†

37

0

Pyrexia

21

2.7*

Edema†

18

1.1*

Gastrointestinal disorders

Diarrhea

36

1.1*

Nausea

22

0

Constipation

15

0

Vomiting

14

0

Infections

Upper respiratory tract infection†

34

4.9

Pneumonia‡

32

19

Sepsis§

15

11

Urinary tract infection†

12

4.4*

Musculoskeletal and connective tissue disorders

Musculoskeletal pain†

34

2.7*

Metabolism and nutrition disorders

Decreased appetite

26

1.1*

Skin and Subcutaneous Tissue disorders

Rash

25

0

Dry skin

13

0

Skin exfoliation†

10

0

Respiratory, thoracic and mediastinal disorders

Cough†

24

0

Dyspnea†

15

3.3*

Nervous system disorders

Headache

18

0.5

Encephalopathy#

15

2.7

Sensory neuropathyÞ

13

0.5*

Motor dysfunctionß

13

2.2*

Cardiac disorders

Cardiac arrhythmia†

16

2.2

Vascular disorders

Hemorrhage†

13

1.6

Psychiatric disorders

Insomnia

13

0

Injury, poisoning and procedural complications

Fall

10

0.5*

Clinically relevant adverse reactions in <10% of patients who received ELREXFIO included ICANS, febrile neutropenia, Guillain-Barré syndrome, abdominal pain, acute kidney injury, COVID-19, cardiac failure, congestion, and thrombosis.

Table 9 summarizes laboratory abnormalities in MagnetisMM-3.

Table 9. Select Laboratory Abnormalities (≥30%) That Worsened from Baseline in Patients with Relapsed or Refractory Multiple Myeloma Who Received ELREXFIO in MagnetisMM-3*
*
Laboratory tests were graded according to NCI-CTCAE Version 5.0
†
The denominator used to calculate the rate varied from 181 to 183 based on the number of patients with a baseline value and at least one post-treatment value.

Laboratory Abnormality

ELREXFIO†

All Grades (%)

Grade 3 or 4 (%)

Hematology

Lymphocyte count decreased

91

84

White blood cell decreased

69

40

Hemoglobin decreased

68

43

Neutrophil count decreased

62

51

Platelet count decreased

61

32

Chemistry

Albumin decreased

55

6

AST increase

40

6

Creatinine increased

38

3.3

Potassium decreased

36

8

ALT increase

36

3.8

Alkaline phosphatase increased

34

1.1

Creatinine clearance decreased

32

10
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