(elranatamab-bcmm) injection, for subcutaneous use
What is the most important information I should know about ELREXFIO?
ELREXFIO may cause serious side effects, including:
Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with ELREXFIO, as well as other side effects, and will treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with ELREXFIO if you develop CRS, neurologic problems, or any other side effects that are severe.
If you have any questions about ELREXFIO, ask your healthcare provider.
See “What are possible side effects of ELREXFIO?” for more information about side effects.
What is ELREXFIO?
ELREXFIO is a prescription medicine used to treat adults with multiple myeloma who:
It is not known if ELREXFIO is safe and effective in children.
Before receiving ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive ELREXFIO?
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment with ELREXFIO.
What should I avoid while receiving ELREXFIO?
Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:
See “What is the most important information I should know about ELREXFIO?” for more information about signs and symptoms of neurologic problems.
What are the possible side effects of ELREXFIO?
Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.
The most common side effects of ELREXFIO include:
The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.
These are not all of the possible side effects of ELREXFIO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ELREXFIO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for more information about ELREXFIO that is written for health professionals.
What are the ingredients in ELREXFIO?
Active ingredient: elranatamab-bcmm
Inactive ingredients: edetate disodium, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection
Manufactured by: Pfizer Inc., NY, NY 10001
US License No. 2001
For more information on ELREXFIO, go to www.ELREXFIO.com
For more information on Pfizer, go to www.Pfizer.com or call 1-800-438-1985
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: August 2023
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Cytokine Release Syndrome (CRS)
Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, tachycardia, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].
Neurologic Toxicity, Including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, encephalopathy, motor dysfunction, sensory neuropathy, and Guillain-Barré Syndrome. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating 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 neurological toxicity symptoms until symptoms resolve [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].
ELREXFIO is available only through a restricted program called ELREXFIO REMS. Inform patients that they will be given an ELREXFIO Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3)].
Discuss the signs and symptoms of infection [see Dosage and Administration (2.5), Warnings and Precautions (5.4)].
Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5), Warnings and Precautions (5.5)].
Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].
Advise women not to breastfeed during treatment with ELREXFIO and for 4 months after the last dose [see Use in Specific Populations (8.2)].
Manufactured by:Pfizer Inc.NY, NY 10001US License No. 2001LAB-1518-1.0
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