Anti-CD38 Monoclonal Antibody — Myeloma Pregnancy: Avoid — no adequate data; IgG crosses placenta; potential for fetal B-cell depletion; effective contraception required

Daratumumab

Brand names: Darzalex

Adult dose

Dose: 16 mg/kg IV

Route: IV infusion (diluted; first infusion ~7 hours; subsequent infusions ~4–5 hours then ~3 hours if tolerated)

Frequency: Weekly × 8 doses, then every 2 weeks × 8 doses, then every 4 weeks

Max: 16 mg/kg per dose

Used in multiple myeloma — DRd (daratumumab + lenalidomide + dexamethasone), DVd (daratumumab + bortezomib + dexamethasone), and other combinations. First-line and relapsed/refractory settings. Subcutaneous formulation (Darzalex Faspro) available — 1,800 mg SC fixed dose (3–5 min injection).

Paediatric dose

Dose: Seek specialist opinion mg/kg

Route: IV

Frequency: Per haematology protocol

Max: Not established in children

Not licensed in children; seek specialist paediatric haematology opinion

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment required in mild hepatic impairment; limited data in severe impairment

Paediatric weight-based calculator

Patient weight (kg)

Not licensed in children; seek specialist paediatric haematology opinion

Clinical pearls

CD38 is expressed on red blood cells — daratumumab causes pan-positive indirect antiglobulin test (indirect Coombs) — inform blood bank BEFORE starting treatment; type and screen must be performed before first dose
MAIA trial: DRd (daratumumab + lenalidomide + dexamethasone) significantly improved PFS vs Rd alone in newly diagnosed transplant-ineligible myeloma
CASTOR trial: DVd superior to Vd in relapsed/refractory myeloma
Premedication mandatory before each infusion: antihistamine, antipyretic, corticosteroid (reduces IRR risk)
SC formulation (Darzalex Faspro): 1,800 mg + recombinant human hyaluronidase; 3–5 min injection vs hours IV — preferred in practice where available
Herpes zoster prophylaxis recommended during treatment

Contraindications

Hypersensitivity to daratumumab

Side effects

Infusion-related reactions (IRR — most common first infusion: bronchospasm, cough, hypoxia)
Neutropenia
Thrombocytopenia
Anaemia
Fatigue
Pneumonia
Upper respiratory infections

Interactions

Interference with blood group serology — CD38 expressed on red cells; causes pan-agglutination in indirect antiglobulin test; inform blood bank before treatment

Monitoring

FBC (before each cycle)
Infusion-related reaction monitoring (vital signs during infusion)
Infection surveillance
Blood bank notification

Reference: BNFc; BNF 90; MAIA Trial (Facon et al. NEJM 2019); CASTOR Trial (Palumbo et al. NEJM 2016); NICE TA529; SPC Darzalex. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways