Elranatamab Side Effects
Medically reviewed by Drugs.com. Last updated on Oct 16, 2024.
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.
Ask your doctor for a patient wallet card. This card will list the symptoms of cytokine release syndrome and nervous system problems. Carry the card with you at all times during treatment. You will need to show the card to any doctor who treats you.
This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may cause serious liver problems. Check with your doctor right away if you have clay colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
This medicine may cause dizziness, confusion, sleepiness, or tremors. Do not drive or do anything else that could be dangerous during and for 48 hours after receiving this medicine until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 side effects
- 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 side effects
- 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 side effects
- 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 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 side effects
- 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 adverse events
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]
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References
1. (2023) "Product Information. Elrexfio (elranatamab)." Pfizer U.S. Pharmaceuticals Group
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Further information
Elranatamab 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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.