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Elranatamab Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 20, 2024.

Applies to elranatamab: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Warning: 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 elranatamab-bcmm. Initiate treatment with elranatamab-bcmm step-up dosing schedule to reduce the risk of CRS. Withhold elranatamab-bcmm 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 elranatamab-bcmm. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold elranatamab-bcmm until the neurologic toxicity resolves or permanently discontinue based on severity.Because of the risk of CRS and neurologic toxicity, including ICANS, elranatamab-bcmm is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS.

Serious side effects of Elranatamab

Along with its needed effects, elranatamab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking elranatamab:

More common

Less common

Rare

Incidence not known

Other side effects of Elranatamab

Some side effects of elranatamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to elranatamab: subcutaneous solution.

General

The most common adverse reactions were cytokine release syndrome (CRS), fatigue, musculoskeletal pain, rash, injection site reaction, diarrhea, upper respiratory tract infection, decreased appetite, cough, nausea, and pyrexia. Serious adverse reactions occurred in 68% of patients and fatal reactions in 10%, including pneumonia and sepsis.[Ref]

Cardiovascular

Very common (10% or more): Cardiac arrhythmia (16%)

Uncommon (0.1% to 1%): Cardiac failure, cardio-respiratory arrest, cardiogenic shock[Ref]

Dermatologic

Very common (10% or more): Rash (25%), dry skin (13%), skin exfoliation (10%)[Ref]

Rash includes erythema, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculopapular, rash pustular, symmetrical drug-related intertriginous and flexural exanthema.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (36%), nausea (22%), constipation (15%), vomiting (14%)

Frequency not reported: Abdominal pain[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (58%), hypogammaglobulinemia (13%)[Ref]

Local

Very common (10% or more): Fatigue (43%), injection site reaction (37%), pyrexia (21%), edema (18%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (26%)

Uncommon (0.1% to 1%): Failure to thrive[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (34%)[Ref]

Nervous system

Very common (10% or more): Headache (18%), encephalopathy (15%), sensory neuropathy (13%), motor dysfunction (13%)

Common (1% to 10%): Immune effector cell-associated neurotoxicity syndrome (ICANS), Guillain-Barre syndrome[Ref]

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, and toxic encephalopathy.

Sensory neuropathy includes burning sensation, dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, parosmia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, and sensory loss.

Motor dysfunction includes ataxia, balance disorder, gait disturbance, motor dysfunction, muscle contracture, muscle spasms, muscular weakness, peripheral motor neuropathy, peroneal nerve palsy, and tremor.[Ref]

Other

Very common (10% or more): upper respiratory tract infection (34%), pneumonia (32%), sepsis (15%), urinary tract infection (12%), hemorrhage (13%), fall (10%), increased aspartate aminotransferase (40%), increased alanine aminotransferase (36%), decreased potassium (36%), decreased albumin (55%), increased alkaline phosphatase (34%), decreased creatinine clearance (32%), increased creatinine (28%), decreased lymphocyte count (91%), decreased hemoglobin (68%), decreased neutrophils (62%), decreased platelets (61%), decreased white blood cell (69%)

Common (1% to 10%): Febrile neutropenia, thrombosis

Frequency not reported: Thrombosis, COVID-19[Ref]

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.[Ref]

Psychiatric

Very common (10% or more): Insomnia (13%)[Ref]

Renal

Frequency not reported: Acute kidney injury[Ref]

Respiratory

Very common (10% or more): Cough (24%), dyspnea (15%)

Uncommon (0.1% to 1%): Acute respiratory distress syndrome, pulmonary embolism

Frequency not reported: Congestion[Ref]

References

1. Product Information. Elrexfio (elranatamab). Pfizer U.S. Pharmaceuticals Group. 2023.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.