Prescription medicine

Elranatamab Brand names: Elrexfio

Elranatamab (Elrexfio) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the elranatamab FDA label on DailyMed (effective May 14, 2026, U.S. Pharmaceuticals); the BLA 761345 record on Drugs@FDA; every elranatamab label on DailyMed.

Highlights of the record

FDA label of May 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed 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 ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce the risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ), Warnings and Precautions (5.1) ].

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 [see Dosage and Administration (2.5), Warnings and Precautions (5.2) ].

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 [see Warnings and Precautions (5.3) ]. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. […]

Used for

From the label: indications and usage
ELREXFIO is 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.

Forms and strengths

44 mg/1.1ml
76 mg/1.9ml

Injection (solution).

On the market

Earliest approval on file: August 14, 2023 Elrexfio, Pfizer Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 1,037 through July 30, 2026

What is elranatamab used for?

From the label: indications and usage
ELREXFIO is 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 [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). […]

Conditions named in the indications of elranatamab's FDA labels, with every medicine labeled for each:

Leukemia, lymphoma and myeloma

Source: FDA drug label (Elrexfio), BLA761345 (Pfizer Inc), as published by U.S. Pharmaceuticals, effective May 14, 2026 (SPL set aa044060-5b4b-4692-bf0f-9a50e140b10e), via openFDA; the full label on DailyMed

What does the patient leaflet for elranatamab say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about ELREXFIO?
ELREXFIO may cause serious side effects, including: • Cytokine Release Syndrome (CRS). CRS is common during treatment with ELREXFIO and can also be serious, life-threatening, or can lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: o fever of 100.4 °F (38 °C) or higher o trouble breathing o chills o dizziness or light-headedness o fast heartbeat o headache o increased liver enzymes in your blood. See “ What are the possible side effects of ELREXFIO? ” for more information about the signs and symptoms of liver problems. Due to the risk of CRS, you will receive ELREXFIO on a “step-up dosing schedule” and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO. o During the step-up dosing schedule: ▪ for your first dose, you will receive a smaller “step-up” dose of ELREXFIO on Day 1 of your treatment ▪ for your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on Day 4 of your treatment ▪ for your third dose, you will receive the first full “treatment” dose of ELREXFIO, which is usually given on Day 8 of your treatment o If your dose of ELREXFIO is delayed for any reason, you may need to repeat the step-up dosing schedule. o Before each step-up dose and the first full treatment dose of ELREXFIO, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses. o See “ How will I receive ELREXFIO? ” for more information about how you will receive ELREXFIO. • Neurologic problems. ELREXFIO can cause neurologic problems that can be serious or life-threatening. […]

From the patient leaflet: 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: • for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the “step-up dosing schedule” and your first full treatment dose, and • at any time during treatment with ELREXFIO if you develop any new neurologic symptoms such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away. See “ What is the most important information I should know about ELREXFIO? ” for more information about signs and symptoms of neurologic problems.

Is there a generic for elranatamab (Elrexfio)?

No generic elranatamab is approved (Drugs@FDA, October 8, 2026).

2023 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for elranatamab?

The FDA Adverse Event Reporting System holds 1,037 reports that list elranatamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 244 are coded as a death and 299 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Cytokine Release Syndrome (named in the label)184
Death (an outcome recorded in the report)98
Malignant Neoplasm Progression80
Pyrexia (named in the label)70
Cytomegalovirus Infection Reactivation54
Off Label Use (a use or a product term, not a reaction)53
Fatigue (named in the label)51
Immune Effector Cell-Associated Neurotoxicity Syndrome (named in the label)51

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as elranatamab?

7 other medicines are given the same way (subcutaneous) and in the same FDA class as elranatamab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (subcutaneous)	Pharmacy cost	Shortage
Epcoritamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Hyaluronidase and rituximab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Mosunetuzumab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Talquetamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Teclistamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Daratumumab and hyaluronidase	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Isatuximab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Elranatamab side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other