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BCMA×CD3 Bispecific Antibody Pregnancy: Contraindicated — insufficient safety data; effective contraception required during and for 5 months after treatment

Teclistamab

Brand names: Tecvayli

Adult dose

Dose: Step-up: 0.06 mg/kg SC (D1), 0.3 mg/kg SC (D3-4); then 1.5 mg/kg SC weekly; biweekly after ≥24 weeks if sustained CR
Route: Subcutaneous injection
Frequency: Weekly → biweekly in sustained CR
Max: 1.5 mg/kg per dose
R/R multiple myeloma ≥4 prior lines including PI, IMiD, anti-CD38; step-up dosing mandatory; hospitalisation required for first two step-up doses (48h observation each)

Paediatric dose

Dose: Not established N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed in paediatrics

Dose adjustments

Renal

No dose adjustment required for CrCl ≥20 mL/min; limited data below

Hepatic

No formal adjustment required for mild impairment

Paediatric weight-based calculator

Not licensed in paediatrics

Clinical pearls

  • MajesTEC-1 trial (Moreau et al. NEJM 2022): 63% ORR with 39.4% CR or better in penta-refractory myeloma — MHRA conditionally approved 2022; first BCMA×CD3 bispecific approved in Europe
  • Infection risk is the dominant clinical concern with BCMA-directed bispecifics — 76% patients experienced infections in MajesTEC-1; COVID-19 prophylaxis, PCP prophylaxis (co-trimoxazole), VZV prophylaxis (aciclovir), and IVIG replacement are all recommended
  • Tocilizumab must be immediately available for all administrations; CRS grading (ASTCT criteria) and management protocols must be in place before prescribing — treat grade ≥2 with tocilizumab ± dexamethasone
  • Distinction from elranatamab: both target BCMA×CD3; teclistamab is weight-based dosing, elranatamab is fixed flat dosing — clinical selection depends on local approval, patient weight variability, and centre experience
  • MHRA 2022: serious and fatal infections; mandatory PCP and VZV prophylaxis; IVIG for IgG <4 g/L or recurrent infections — checklist must be reviewed before each cycle

Contraindications

  • Active uncontrolled infections
  • Known hypersensitivity
  • Prior anaphylaxis to any bispecific

Side effects

  • CRS (cytokine release syndrome — step-up mitigates severity)
  • ICANS/neurotoxicity
  • Hypogammaglobulinaemia (universal, prophylactic IVIG required)
  • Neutropenia
  • Infections (COVID-19, pneumonia, herpes zoster — high incidence)
  • Injection site reactions
  • Fatigue

Interactions

  • Live vaccines — avoid during and for ≥3 months after final dose; profound immune suppression
  • Corticosteroids — pre-medication mandatory (dexamethasone 16 mg before each step-up dose)
  • Other immunosuppressants — additive immune suppression

Monitoring

  • CRS assessment (vital signs during and 48h after each step-up dose)
  • ICANS neurological grading
  • FBC (weekly)
  • Immunoglobulin levels (every 3 months)
  • Infection screening (CXR, cultures, COVID PCR if symptomatic)
  • VZV serology at baseline

Reference: BNFc; BNF 90; MajesTEC-1 trial (Moreau et al. NEJM 2022); MHRA SPC Tecvayli 2022; NICE TA898; MajesTEC-4 trial ongoing. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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