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elranatamab

Elrexfio · ATC code 333

Key facts
Active substance
elranatamab
ATC code
333
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ELREXFIO 40 mg/mL solution for injection
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-29

Key facts

Elranatamab is a subcutaneous injectable medicine for multiple myeloma. It is used as monotherapy in adults with relapsed and refractory multiple myeloma after at least three prior therapies.

What it is used for

  • Monotherapy for adults 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 progressed on the last therapy (Elrexfio).

Dosing

  • Subcutaneous injection by a healthcare professional with equipment to manage severe reactions (CRS, ICANS).
  • Step-up dosing: 12 mg (week 1, day 1) and 32 mg (week 1, day 4), then 76 mg once weekly from week 2 to week 24.
  • After at least 24 weeks with a response: 76 mg every two weeks; if the response is maintained after a further 24 weeks: every four weeks.
  • Before the first three doses, about 1 hour beforehand: paracetamol 500 mg, dexamethasone 20 mg and diphenhydramine 25 mg (or equivalent).
  • Monitor for CRS and ICANS for 48 hours after each of the 2 step-up doses and stay near a healthcare facility. See the full text for dose delays and restarting.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Cytokine release syndrome (CRS), including life-threatening or fatal reactions; step-up dosing and pre-medication reduce the risk.
  • Neurotoxicity including ICANS: no driving or operating machinery during step-up dosing and for 48 hours after.
  • Severe, life-threatening or fatal infections, including CMV reactivation and PML; prophylaxis per local guidelines.
  • Neutropenia and febrile neutropenia: monitor blood counts.
  • Hypogammaglobulinaemia: monitor immunoglobulins; consider immunoglobulin if IgG falls below 400 mg/dL.
  • Live viral vaccines are not recommended within 4 weeks before the first dose and during treatment.

Side effects

  • Very common: CRS (57.9%), anaemia (54.1%), neutropenia (45.9%), fatigue (44.8%), upper respiratory tract infection (43.2%), diarrhoea (42.1%), pneumonia (38.3%), injection site reaction (38.3%), thrombocytopenia (36.6%), lymphopenia (30.1%).
  • Serious: pneumonia (31.7%), sepsis (15.8%), CRS (12.6%), anaemia (5.5%), upper respiratory tract infection (5.5%).

Interactions

  • Cytokine release may suppress CYP enzymes; for up to 14 days after step-up dosing or after CRS, monitor levels or toxicity of sensitive narrow-therapeutic-index CYP substrates (e.g. ciclosporin, phenytoin, sirolimus, warfarin).

Pregnancy and breastfeeding

  • May cause foetal harm; not recommended during pregnancy. Women of child-bearing potential should use contraception during treatment and for 6 months after the last dose.
  • Breast-feeding: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ElrexfioPfizer Europe MA EEIG · EMEA/H/C/005908

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Elrexfio
Liechtenstein
Elrexfio
Norway
Elrexfio

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Elrexfio – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/elrexfio-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.