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Drug reference

naxitamab

Anti-GD2 monoclonal antibody (humanised) · anticancer

START
3 mg/kg/day IV days 1,3,5 with GM-CSF (premedicate)
TYPICAL MAX
150 mg/day (3 mg/kg/day)
STOP IF
Severe infusion reaction, PRES, or transverse myelitis
WATCH
Infusion reactions, BP, neuro status, pain control, sodium
CDSCO approvedATC L01FX21
Dose laddermg/d
3mg/kg/day150daily cap
Renal dose adjustmenteGFR mL/min/1.73m²
FULLNo specific adjustment (limited data)90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
6minONSET1hPEAK6d4wDURATION
ONSET
6min · infusion start
PEAK
1h · end infusion
6d · t½ ~6 d
DURATION
4w · q4w cycle
EXCRETION
Proteolytic catabolism; not excreted intact
route + CYP
INTERACTIONS
12 major
SEVERE in our sources
PREGNANCY
Can cause fetal harm — avoid; effective contraception required.
FDA category + note
Top interactionssee all 12
  • AdalimumabSevereDatabaseDDInter
  • BaricitinibSevereDatabaseDDInter
  • CertolizumabSevereDatabaseDDInter
  • CladribineSevereDatabaseDDInter

Mechanism

Humanised IgG1 monoclonal antibody binding ganglioside GD2 on neuroblastoma cells, triggering complement-dependent and antibody-dependent cellular cytotoxicity.

Indications

Relapsed/refractory high-risk neuroblastoma in bone/bone marrow (with GM-CSF)

Dosing

Adult
Pediatric disease: 3 mg/kg/day IV (max 150 mg/day) on days 1, 3, 5 of each cycle with GM-CSF; cycles every 4 weeks.
Pediatric
Primary population: 3 mg/kg/day IV days 1,3,5 per cycle (premedicate).
Renal adjustment
No specific adjustment (limited data).
Hepatic adjustment
No specific adjustment (limited data).
Geriatric
Not applicable (paediatric disease).
Max dose
150 mg/day (3 mg/kg/day) on days 1, 3, 5

Pharmacokinetics

Onset
Antitumour effect over cycles
Peak effect
End of infusion (serum)
Duration
Cycle every 4 weeks
Half-life
~5–7 days
Bioavailability
IV 100%
Protein binding
Not applicable (antibody)
Metabolism
Proteolytic catabolism
Excretion
Catabolised (not renally/hepatically excreted intact)

Contraindications

  • Severe hypersensitivity to naxitamab
  • Caution: requires premedication and resuscitation readiness

Side effects

Common
Severe infusion-related painHypotensionBronchospasm/coughVomitingPyrexiaHypertension
Serious
  • Serious infusion reactions/anaphylaxis
  • Severe neuropathic pain
  • Posterior reversible encephalopathy
  • Hypertension
  • Transverse myelitis (boxed)
  • Severe hyponatraemia

Pregnancy & lactation

Pregnancy

Can cause fetal harm — avoid; effective contraception required.

Lactation

Avoid breastfeeding during and 2 months after therapy.

Drug interactions

Adalimumab
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Baricitinib
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Certolizumab
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Cladribine
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Clozapine
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Deferiprone
Severe
Database

Clinical effect not specified

Source: DDInter

Etanercept
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Fingolimod
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Golimumab
Severe
Database

Clinical effect not specified

Source: DDInter

Infliximab
Severe
Database

Clinical effect not specified

Source: DDInter

Leflunomide
Severe
Database

Clinical effect not specified

Source: DDInter

Measles Virus Vaccine Live Attenuated
Severe
Database

Clinical effect not specified

Source: DDInter

Related guidelines

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Sources: Goodman & Gilman 14e·Verified: 2026-05-20 · House clinical team·Cockpit curated: 2026-05-20