Belantamab Mafodotin
Blenrep · ATC code L01FX15
- Key facts
- Active substance
- Belantamab Mafodotin
- ATC code
- L01FX15
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Blenrep 70 mg powder for concentrate for solution for infusion / Blenrep 100 mg powder for concentrate for solution for infusion
- Marketing authorisation holder
- GlaxoSmithKline Trading Services Limited
- Information as of
- 2026-10-28
Key facts
Belantamab mafodotin (Blenrep) is a BCMA-directed antibody-drug conjugate given by infusion. It is used in combination regimens for relapsed or refractory multiple myeloma.
What it is used for
- Adults with relapsed or refractory multiple myeloma, in combination with bortezomib and dexamethasone after at least one prior therapy.
- In combination with pomalidomide and dexamethasone after at least one prior therapy including lenalidomide.
Dosing
- With bortezomib and dexamethasone (3-week cycles): 2.5 mg/kg once every 3 weeks; bortezomib and dexamethasone are given for the first 8 cycles.
- With pomalidomide and dexamethasone (4-week cycles): 2.5 mg/kg once in cycle 1, then 1.9 mg/kg every 4 weeks from cycle 2.
- Dose modifications are required for nearly all patients; reduction levels (e.g. 1.9 mg/kg every 3 weeks or every 8 weeks) are in the full text.
- Continue until disease progression or unacceptable toxicity.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
Important warnings
- Ocular adverse reactions (blurred vision, dry eye, eye irritation, photophobia) and corneal findings such as keratopathy are common.
- Ophthalmic examination (visual acuity, slit lamp) before each of the first 4 doses and thereafter as clinically indicated.
- Preservative-free artificial tears at least 4 times a day; avoid contact lenses until the end of treatment.
- Temporarily avoid driving or operating machinery if visual symptoms occur.
Side effects
- Most common: corneal examination findings including keratopathy (84%), visual acuity reduced (81%), thrombocytopenia (62%), vision blurred (52%), dry eye, foreign body sensation, photophobia, neutropenia, anaemia, diarrhoea, neuropathies.
- Most common serious adverse reactions: pneumonia (9%), pyrexia, COVID-19 and thrombocytopenia.
Interactions
- No interaction studies performed; low risk of pharmacokinetic or pharmacodynamic interactions.
- No clinically relevant interactions with bortezomib, lenalidomide, pomalidomide or dexamethasone.
Pregnancy and breastfeeding
- Not recommended during pregnancy unless the benefit to the mother outweighs the risks to the foetus; verify pregnancy status before starting.
- Effective contraception: women for at least 4 months, men with partners of child-bearing potential for at least 6 months after the last dose.
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.
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)
- BlenrepGlaxoSmithKline Trading Services Limited · EMEA/H/C/006511
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Blenrep
- Liechtenstein
- Blenrep
- Norway
- Blenrep
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.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Blenrep – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.