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blinatumomab

Blincyto · ATC code L01FX07

Key facts
Active substance
blinatumomab
ATC code
L01FX07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-27

Key facts

Blinatumomab is a bispecific CD19/CD3-directed T-cell engager (monoclonal antibody). It is used as monotherapy for CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

What it is used for

  • Adults with relapsed or refractory CD19-positive B-cell precursor ALL (Philadelphia chromosome-positive only after failure of at least 2 TKIs and with no alternatives)
  • Adults with Philadelphia chromosome-negative B-cell precursor ALL in first or second complete remission with MRD ≥0.1%
  • Children aged 1 month or older with refractory or relapsed Philadelphia chromosome-negative ALL after at least two prior therapies or after allogeneic stem cell transplantation
  • Children aged 1 month or older with high-risk first relapse, as part of consolidation
  • Adults with newly diagnosed Philadelphia chromosome-negative B-cell precursor ALL, as part of consolidation

Dosing

  • Continuous intravenous infusion; one cycle is 28 days followed by a 14-day treatment-free interval
  • Relapsed/refractory ALL, 45 kg or more: cycle 1 days 1–7 9 mcg/day, from day 8 28 mcg/day; subsequent cycles 28 mcg/day
  • Under 45 kg: dosed by body surface area (5 or 15 mcg/m2/day)
  • Hospitalisation recommended at initiation (e.g. relapsed/refractory ALL: at least the first 9 days of cycle 1)
  • Premedication and regimens for other indications are in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Breast-feeding

Important warnings

  • Neurologic events including ICANS, some fatal (e.g. encephalopathy, seizures, speech disorders, confusion); median onset within the first 2 weeks
  • Elderly patients and those with a history of neurologic symptoms have a higher rate of neurologic events
  • Cytokine release syndrome
  • Serious infections
  • Traceability: record name and batch number

Side effects

  • Most serious: infections (22.6%), neurologic events (12.2%), neutropenia/febrile neutropenia (9.1%), cytokine release syndrome (2.7%), tumour lysis syndrome (0.8%)
  • Most common: pyrexia (70.8%), infections (41.4%), infusion-related reactions (33.4%), headache (32.7%), nausea (23.9%), anaemia (23.3%)

Interactions

  • Transient cytokine release at initiation may suppress CYP450 enzymes; monitor narrow-therapeutic-index substrates (e.g. warfarin, cyclosporine) and adjust doses as needed

Pregnancy and breastfeeding

  • Women of childbearing potential must use effective contraception during and for at least 48 hours after treatment; no data in pregnant women
  • Breast-feeding is contraindicated

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

Package leaflet for patients →

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)

  • BlincytoAmgen Europe B.V. · EMEA/H/C/003731

Source: European Medicines Agency (EMA), product information

Turkey

  • BlincytoAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 2 more European countries
Iceland
Blincyto
Norway
Blincyto

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

  1. European Medicines Agency. Blincyto – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.