Elrexfio Side Effects

Generic name: elranatamab

Medically reviewed by Drugs.com. Last updated on Apr 12, 2024.

Note: This document provides detailed information about Elrexfio Side Effects associated with elranatamab. Some dosage forms listed on this page may not apply specifically to the brand name Elrexfio.

Applies to elranatamab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

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 Elrexfio

Along with its needed effects, elranatamab (the active ingredient contained in Elrexfio) 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

• agitation
• back pain
• being forgetful
• bladder pain
• bleeding gums
• bloody or cloudy urine
• blurred or double vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, or tightness
• coma
• confusion
• confusion as to time, place, or person
• cough
• coughing up blood
• diarrhea
• difficult, burning, or painful urination
• dizziness
• drowsiness
• ear congestion
• fainting
• fast heartbeat
• fever or chills
• frequent urge to urinate
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased menstrual flow or vaginal bleeding
• irritability
• lightheadedness
• loss of taste or smell
• loss of voice
• lower back or side pain
• mental depression or anxiety
• mood or mental changes
• muscle or bone pain
• nightmares or unusually vivid dreams
• nosebleeds
• paralysis
• pounding or rapid pulse
• prolonged bleeding from cuts
• rapid or irregular heartbeat
• red or black, tarry stools
• red or dark brown urine
• seizures
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• stiff neck
• stuffy or runny nose
• swelling
• trembling and shaking of the hands
• trouble breathing
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual excitement, nervousness, or restlessness
• vomiting

Less common

• decreased urine output
• hostility
• muscle twitching
• nausea
• pale skin
• rapid weight gain
• stupor
• swelling of the face, ankles, or hands
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising

Rare

• cool, sweaty skin
• inability to move the arms and legs
• sudden numbness and weakness in the arms and legs

Incidence not known

• dark urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• loss of appetite
• stomach pain, severe
• yellow eyes or skin

Other side effects of Elrexfio

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

• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• constipation
• dry skin
• fall
• trouble sleeping

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]

Further information

Elrexfio side effects can vary depending on the individual. 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.

Medical Disclaimer