Elranatamab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 30, 2026🚩 Report this page

Elranatamab

Other Monoclonal Antibodies and Antibody Drug Conjugates

Sold as Elrexfio

EU EMACA Health CanadaGB MHRA

Drug class: Other Monoclonal Antibodies and Antibody Drug Conjugates
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 4

L01FXOther Monoclonal Antibodies and Antibody Drug Conjugates

Overview

Elranatamab is an active pharmaceutical ingredient in the Other Monoclonal Antibodies and Antibody Drug Conjugates group (L01FX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	January 16, 2026
CA Canada	Health Canada	2	April 30, 2026
GB United Kingdom	MHRA	1	February 20, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 16, 2026[1]

ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

How to take

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Brands in Canada (1)

ELREXFIOPFIZER CANADA ULC

GBUnited Kingdom· MHRA

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Sources & citations

[1]European Medicines Agency · EMEA/H/C/005908 · revised January 16, 2026
[2]Health Canada (DPD) · 02543559 · revised April 30, 2026
[3]MHRA (UK) · PLGB000571723 · revised February 20, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. 4). Prior to initiating treatment, complete blood count should be performed. 6). 3 Posology Recommended dosing schedule The recommended doses are step-up doses of 12 mg on day 1 and 32 mg on day 4, followed by a full treatment dose of 76 mg weekly from week 2 to week 24 (see Table 1).
For patients who have received at least 24 weeks of treatment and have achieved a response, the dosing interval should transition to an every two-week schedule. For patients who have received at least 24 weeks of treatment at the every two week schedule and have maintained the response, the dose interval should transition to an every four week schedule.
ELREXFIO should be administered according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of CRS and ICANS. 4). Table 1. ELREXFIO dosing schedule Dosing schedule Week/day Dose Step-up dosinga,b Week 1: day 1 Step-up dose 1 12 mg Week 1: day 4 Step-up dose 2 32 mg Weekly dosinga,c,d Week 2-24: day 1 Full treatment dose 76 mg once weekly Every 2 weeks dosingd,e Week 25-48: day 1 Full treatment dose 76 mg once every two weeks Every 4 weeks dosingd,f,g Week 49 onward: day 1 Full treatment dose 76 mg once every four weeks a.
Pre-treatment medicinal products should be administered prior to the first three doses of ELREXFIO. b. A minimum of 2 days should be maintained between step-up dose 1 (12 mg) and step-up dose 2 (32 mg). c. A minimum of 3 days should be maintained between step-up dose 2 (32 mg) and the first full treatment (76 mg) dose.
d. A minimum of 6 days should be maintained between doses. e. For patients who have achieved a response. f. For patients who have received at least 24 weeks of treatment at the every two week schedule. g. For patients who maintained the response.
Note:
See Table 5 for recommendations on restarting ELREXFIO after dose delays. 4). Dose modifications based on toxicity Dose reductions of ELREXFIO are not recommended. 4). See Tables 2 and 3 for recommended actions for adverse reactions of CRS and ICANS, respectively.
See Table 4 for recommended actions for other adverse reactions. 4). Patients should be evaluated and treated for other causes of fever, hypoxia, and hypotension. ) should be administered as appropriate. Laboratory testing to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function should be considered.
Table 2. c • Provide supportive therapy. c • Provide supportive therapy. • Monitor patients daily for 48 hours following the next dose of ELREXFIO. Instruct patients to remain within proximity of a healthcare facility. c • Provide supportive therapy, which may include intensive care.
• Administer pre-treatment medicinal products prior to the next dose of ELREXFIO. • Monitor patients daily for 48 hours following the next dose of ELREXFIO. Instruct patients to remain within proximity of a healthcare facility. Grade 3 (Recurrent) Temperature ≥ 38 °C with either: • Hypotension requiring one vasopressor with or without vasopressin, and/or • Oxygen requirement of high-flow nasal cannulad, facemask, non-rebreather mask, or Venturi mask • Permanently discontinue therapy.
• Provide supportive therapy, which may include intensive care. , continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation, and mechanical ventilation) • Permanently discontinue therapy. • Provide supportive therapy, […]

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised January 16, 2026[1]

8%). 2%). Tabulated list of adverse reactions Table 6 summarises adverse reactions reported in patients who received ELREXFIO at the recommended dosing regimen (N=183 including 64 patients with prior BCMA-directed antibody drug conjugate [ADC] or chimeric antigen receptor [CAR] T cell therapy [supportive Cohort B]).
9) months. The safety data of ELREXFIO was also evaluated in the all-treated population (N=265) with no additional adverse reactions identified. Adverse reactions are listed according to the MedDRA system organ classification and by frequency.
Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness. Table 6. 1 13 Table 6. 8

EUOfficial regulatory label· Warnings and precautions· revised January 16, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Cytokine release syndrome (CRS) CRS, including life-threatening or fatal reactions, may occur in patients receiving ELREXFIO.
8). Therapy should be initiated according to the step-up dosing schedule to reduce risk of CRS and patients should be monitored following administration of ELREXFIO accordingly. 2). Patients should be counselled to seek urgent medical attention should signs or symptoms of CRS occur.
At the first sign of CRS, ELREXFIO should be withheld and patients should be immediately evaluated for hospitalisation. 2, and further management should be considered per local institutional guidelines. ) should be administered as appropriate.
Laboratory testing to monitor for disseminated intravascular coagulation (DIC), haematology parameters, as well as pulmonary, cardiac, renal, and hepatic function should be considered. 8). , decrease level of consciousness, seizures and/or motor weakness) of neurologic toxicities during treatment.
Patients should be counselled to seek urgent medical attention should signs or symptoms of neurologic toxicity occur. 10 At the first sign of neurologic toxicity, including ICANS, ELREXFIO should be withheld and neurology evaluation should be considered.
2). 7). 8). New or reactivated viral infections occurred during therapy with ELREXFIO, including cytomegalovirus infection/reactivation. Progressive multifocal leukoencephalopathy (PML), which can be fatal, has also occurred during therapy with ELREXFIO.
Treatment should not be initiated in patients with active infections. Patients should be monitored for signs and symptoms of infection prior to and during treatment with ELREXFIO and treated appropriately. 2). , prevention of herpes zoster reactivation) should be administered according to local institutional guidelines.
8). Complete blood cell counts should be monitored at baseline and periodically during treatment. 2). Patients with neutropenia should be monitored for signs of infection. Supportive therapy should be provided according to local institutional guidelines.
8). Immunoglobulin levels should be monitored during treatment. Treatment with subcutaneous or intravenous immunoglobulin (IVIG) should be considered if IgG levels fall below 400 mg/dL and patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis.
Concomitant use of live viral vaccines The safety of immunisation with live viral vaccines during or following treatment with ELREXFIO has not been studied. Vaccination with live virus vaccines is not recommended within the 4 weeks prior to the first dose, during treatment, and at least 4 weeks after treatment.
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This is not medical advice. Consult a qualified healthcare professional.