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MOAMOAStructural DesignMechanism of ActionBCMA as a Target in MMEfficacyEfficacyStudy DesignStudy Results: BCMA–naïveStudy Results: BCMA–exposedPatient ProfilesSafetySafetyCRSNeurologic ToxicityInfectionsAdverse ReactionsSelect Laboratory AbnormalitiesDosingTherapy ManagementTherapy ManagementELREXFIO Treatment JourneySerious Adverse Reaction ManagementResources and SupportResources and SupportEventsMaterialsVideosAccess SupportTreatment Locator
Prescribing InformationMedication GuideIndication ELREXFIO REMS Patient Site
Most common adverse reactions seen with ELREXFIO1

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide, for ELREXFIO.

Most non-hematologic adverse reactions were low-grade (Grade 1/2).

Adverse reactions occurring in ≥10% of patients1Adverse reactions occurring in ≥10% of patients1
N=183
  All grades (%) Grade 3/4 (%)
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 neuropathy 13 0.5
Motor dysfunction 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
N=183
  All grades (%)
Immune system disorders
Cytokine release
syndrome		 58
Hypogammaglobuli-
nemia		 13
General disorders and site
administration conditions
Fatigue 43
Injection-site
reaction		 37
Pyrexia 21
Edema 18
Gastrointestinal disorders
Diarrhea 36
Nausea 22
Constipation 15
Vomiting 14
Infections
Upper respiratory
tract infection		 34
Pneumonia 32
Sepsis 15
Urinary tract
infection		 12
Musculoskeletal and connective tissue disorders
Musculoskeletal
pain		 34
Metabolism and nutrition disorders
Decreased appetite 26
Skin and subcutaneous tissue disorders
Rash 25
Dry skin 13
Skin exfoliation 10
Respiratory, thoracic, and mediastinal disorders
Cough 24
Dyspnea 15
Nervous system disorders
Headache 18
Encephalopathy 15
Sensory
neuropathy		 13
Motor dysfunction 13
Cardiac disorders
Cardiac
arrhythmia		 16
Vascular disorders
Hemorrhage 13
Psychiatric disorders
Insomnia 13
Injury, poisoning, and procedural
complications
Fall 10
N=183
  Grade 3/4 (%)
Immune system disorders
Cytokine release
syndrome		 0.5
Hypogammaglobuli-
nemia		 2.2
General disorders and site
administration conditions
Fatigue 6
Injection-site
reaction		 0
Pyrexia 2.7
Edema 1.1
Gastrointestinal disorders
Diarrhea 1.1
Nausea 0
Constipation 0
Vomiting 0
Infections
Upper respiratory
tract infection		 4.9
Pneumonia 19
Sepsis 11
Urinary tract
infection		 4.4
Musculoskeletal and connective tissue disorders
Musculoskeletal
pain		 2.7
Metabolism and nutrition disorders
Decreased appetite 1.1
Skin and subcutaneous tissue disorders
Rash 0
Dry skin 0
Skin exfoliation 0
Respiratory, thoracic, and mediastinal disorders
Cough 0
Dyspnea 3.3
Nervous system disorders
Headache 0.5
Encephalopathy 2.7
Sensory
neuropathy		 0.5
Motor dysfunction 2.2
Cardiac disorders
Cardiac arrhythmia 2.2
Vascular disorders
Hemorrhage 1.6
Psychiatric disorders
Insomnia 0
Injury, poisoning, and procedural
complications
Fall 0.5
Safety population was comprised of the 183 patients (those with and without prior BCMA-directed therapy) who received the recommended step-up doses of 12 mg (Day 1) and 32 mg (Day 4).1Adverse reactions graded by NCI CTCAE version 5.0. CRS was assessed by ASTCT 2019 criteria.1ASTCT=American Society for Transplantation and Cellular Therapy; BCMA=B-cell maturation antigen; CRS=cytokine release syndrome; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.Select Laboratory Abnormalities

A summary of laboratory abnormalities in MagnetisMM-3

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INDICATION AND USAGEELREXFIO™ (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
Important Safety InformationWARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity.

Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS.

Cytokine Release Syndrome (CRS): ELREXFIO can cause CRS, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 58% of patients who received ELREXFIO at the recommended dose, with Grade 1 CRS in 44% of patients, Grade 2 CRS in 14% of patients, and Grade 3 CRS in 0.5% of patients. Recurrent CRS occurred in 13% of patients. Most patients experienced CRS after the first step-up dose (43%) or the second step-up dose (19%), with 7% of patients having CRS after the first treatment dose and 1.6% of patients after a subsequent dose. The median time to onset of CRS was 2 (range: 1-9) days after the most recent dose, with a median duration of 2 (range: 1-19) days.

Clinical signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes.

Initiate therapy according to the ELREXFIO step-up dosing schedule to reduce risk of CRS and monitor patients following administration of ELREXFIO accordingly. Administer pretreatment medications prior to each dose in the step-up dosing schedule to reduce risk of CRS.

Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, evaluate patients immediately for hospitalization. Manage CRS according to the recommendations and consider further management per current practice guidelines. Withhold or permanently discontinue ELREXFIO based on severity.

Neurologic Toxicity Including ICANS: ELREXFIO can cause serious or life-threatening neurologic toxicity, including ICANS.

In the clinical trial, neurologic toxicity occurred in 59% of patients who received ELREXFIO at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 7% of patients. Neurologic toxicities included headache (18%), encephalopathy (15%), motor dysfunction (13%), sensory neuropathy (13%), and Guillain-Barré Syndrome (0.5%).

In the clinical trial, ICANS occurred in 3.3% of patients who received ELREXFIO at the recommended dose. Most patients had ICANS after the first step-up dose (2.7%), 1 (0.5%) patient had ICANS after the second step-up dose, and 1 (0.5%) patient had ICANS after subsequent dose(s). Recurrent ICANS occurred in 1.1% of patients. The median time to onset was 3 (range: 1-4) days after the most recent dose, with a median duration of 2 (range: 1-18) days. The most frequent clinical manifestations of ICANS included a depressed level of consciousness and Grade 1 or Grade 2 immune effector cell-associated encephalopathy (ICE) scores. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity occur. Monitor patients for signs and symptoms of neurologic toxicities during treatment with ELREXFIO. At the first sign of neurologic toxicity, including ICANS, evaluate and treat patients immediately based on severity. Withhold or permanently discontinue ELREXFIO based on severity per recommendations and consider further management per current practice guidelines.

Due to the potential for neurologic toxicity, including ICANS, patients receiving ELREXFIO are at risk of depressed level of consciousness. Advise patients not to drive or operate heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until symptoms resolve.

REMS: ELREXFIO is available only through a restricted program under a REMS called the ELREXFIO REMS because of the risks of CRS and neurologic toxicity, including ICANS.

Hepatotoxicity: ELREXFIO can cause hepatotoxicity. In the clinical trial, elevated ALT occurred in 36% of patients, with Grade 3 or 4 ALT elevation occurring in 3.8%; elevated AST occurred in 40% of patients, with Grade 3 or 4 AST elevation occurring in 6%. Grade 3 or 4 total bilirubin elevations occurred in 0.5% of patients. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold ELREXFIO or consider permanent discontinuation of ELREXFIO based on severity.

Infections: ELREXFIO can cause severe, life-threatening, or fatal infections. In the clinical trial, in patients who received ELREXFIO at the recommended dose, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 31% and fatal infections in 7%. The most common serious infections reported (≥5%) were pneumonia and sepsis.

Do not initiate treatment with ELREXFIO in patients with active infections. Monitor patients for signs and symptoms of infection prior to and during treatment with ELREXFIO and treat appropriately. Withhold or permanently discontinue ELREXFIO based on severity. Administer prophylactic antimicrobial and antiviral medications according to current practice guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) as appropriate.

Neutropenia: ELREXFIO can cause neutropenia and febrile neutropenia. In patients who received ELREXFIO at the recommended dose in the clinical trial, decreased neutrophils occurred in 62% of patients, with Grade 3 or 4 decreased neutrophils in 51%. Febrile neutropenia occurred in 2.2% of patients.

Monitor complete blood cell counts at baseline and periodically during treatment. Provide supportive care according to current practice guidelines. Monitor patients with neutropenia for signs of infection. Withhold ELREXFIO based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, ELREXFIO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose.

Adverse Reactions: In patients who received ELREXFIO, the most common adverse reactions (incidence ≥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 or 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.ELREXFIO™ (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).Indication and Usage