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CD3 × CD19 bispecific T-cell engager (specialist) Pregnancy: Should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus; may cause B-cell depletion in newborns exposed in utero (monitor and postpone live-virus vaccines). Women of childbearing potential must use effective contraception during and for at least 48 hours after treatment. Breastfeeding contraindicated during and for at least 48 hours after treatment.

Blinatumomab

Brand names: Blincyto

Blinatumomab is a bispecific T-cell engager (BiTE) antibody construct used in the treatment of B-cell precursor acute lymphoblastic leukaemia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Relapsed or refractory B-cell precursor ALL, patients >=45 kg (fixed dose): Cycle 1 — 9 mcg/day (days 1-7), then 28 mcg/day (days 8-28); subsequent cycles — 28 mcg/day (days 1-28)
Route: Continuous intravenous infusion
Frequency: Continuous infusion. A single cycle = 28 days (4 weeks) continuous infusion followed by a 14-day treatment-free interval (relapsed/refractory and MRD-positive adult regimens)
Max: Fixed maximum 28 mcg/day for patients >=45 kg; BSA-based doses in patients <45 kg not to exceed the corresponding fixed dose
BLINCYTO. Initiate under a physician experienced in treating haematological malignancies. Dose is by body weight: patients >=45 kg receive a fixed dose; patients <45 kg have the dose calculated using body surface area (BSA). Relapsed/refractory B-cell precursor ALL: may receive 2 induction cycles; those in CR/CRh* after 2 cycles may receive up to 3 additional consolidation cycles. >=45 kg — Cycle 1: 9 mcg/day days 1-7 then 28 mcg/day days 8-28; subsequent cycles: 28 mcg/day days 1-28; each cycle followed by 14-day treatment-free interval. <45 kg (BSA-based) — Cycle 1: 5 mcg/m2/day days 1-7 (not to exceed 9 mcg/day) then 15 mcg/m2/day days 8-28 (not to exceed 28 mcg/day); subsequent cycles: 15 mcg/m2/day (not to exceed 28 mcg/day). Philadelphia-chromosome-negative MRD-positive B-cell precursor ALL: 1 induction cycle + up to 3 consolidation cycles; >=45 kg 28 mcg/day days 1-28; <45 kg 15 mcg/m2/day (not to exceed 28 mcg/day); 14-day treatment-free interval. B-cell precursor ALL consolidation phase: single cycle = 28 days continuous infusion + 14-day (adult) or 7-day (paediatric) treatment-free interval; up to 4 consolidation cycles (see Table 3 in SPC — not fully captured). Premedication (adults): dexamethasone 20 mg IV 1 hour before initiation of each cycle (relapsed/refractory); prednisone 100 mg IV or equivalent (e.g. dexamethasone 16 mg) 1 hour before each cycle (MRD-positive). Anti-pyretic (e.g. paracetamol) recommended for first 48 h of each cycle. Intrathecal chemotherapy prophylaxis recommended before and during therapy. Pre-phase for high tumour burden (>=50% marrow blasts or >15,000/microlitre peripheral blasts): dexamethasone (not to exceed 24 mg/day). Hospitalisation recommended for early days of cycles (see SPC). PAEDIATRIC: paediatric dosing is BSA-based (per m2), not per-kg; paediatric premedication differs (dexamethasone 10 mg/m2 [max 20 mg] orally/IV 6-12 h before start, then dexamethasone 5 mg/m2 within 30 min before start, cycle 1 day 1). Verify paediatric regimen and any age limits against the SPC and a children's formulary.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Breastfeeding

Side effects

  • Pyrexia (very common, 62.7%)
  • Infections — pathogen unspecified (38.6%); infusion-related reactions (37.0%)
  • Anaemia (34.7%), neutropenia (31.6%), thrombocytopenia (28.2%)
  • Headache (34.2%)
  • Cytokine release syndrome (14.8%) and neurologic events including ICANS (encephalopathy, seizures, speech disorders, confusion)
  • Nausea, diarrhoea, vomiting; hepatic enzyme increased (25.9%)

Interactions

  • No formal drug interaction studies conducted; initiation causes transient cytokine release that may transiently suppress CYP450 enzymes
  • Concomitant CYP450 substrates with narrow therapeutic index — highest interaction risk during first 9 days of cycle 1 and first 2 days of cycle 2; monitor for toxicity (e.g. warfarin) or drug concentrations (e.g. cyclosporine) and adjust as needed

Clinical monograph

How it works

It simultaneously binds CD19 on B-lineage leukaemic cells and CD3 on T cells, bringing them into contact so that cytotoxic T cells lyse the malignant B cells.

Prescribing in practice

  • It can cause cytokine release syndrome and serious neurological toxicity, so it is initiated in hospital with premedication and close monitoring, particularly during the first cycle.
  • It is given by continuous intravenous infusion under specialist haematology supervision; medication errors with the infusion rate can be life-threatening.
  • Tumour lysis syndrome and infections may occur; CNS prophylaxis considerations and careful handling of the infusion are required.

Monitoring

Monitor closely for neurological symptoms, cytokine release syndrome, full blood count, tumour lysis parameters and signs of infection, especially early in each cycle.

Counselling the patient

  • Report confusion, tremor, difficulty speaking, fever or rash promptly to the treating team.
  • Do not drive or operate machinery while neurological effects are possible.
  • The infusion runs continuously; do not adjust the pump and report any device alarms immediately.

Evidence & guidelines

Its benefit in B-cell precursor acute lymphoblastic leukaemia, including measurable residual disease and relapsed/refractory settings, is supported by trials such as TOWER and reflected in NICE guidance.

Reference: NICE TA589; NICE TA665; BSH ALL; ESMO; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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