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moxetumomab pasudotox-tdfk

Anti-CD22 recombinant immunotoxin (antineoplastic)

START
40 mcg/kg IV over 30 min days 1, 3, 5 per 28-day cycle
TYPICAL MAX
40 mcg/kg IV per dose; up to 6 cycles or until response
STOP IF
Capillary leak syndrome, HUS, severe infusion reaction, or AKI
WATCH
BP/weight (CLS), creatinine + LDH + platelets (HUS), albumin, hydration
CDSCO approvedATC L01XC32
Renal dose adjustmenteGFR mL/min/1.73m²
FULLStandard dosing30CAUTIONNot studied — caution / avoid90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
6minONSET30minPEAK2h4wDURATION
ONSET
6min · infusion start
PEAK
30min · end infusion
2h ·
DURATION
4w · q28d cycle
EXCRETION
Proteolytic catabolism; not excreted intact
route + CYP
INTERACTIONS
3 major
SEVERE in our sources
PREGNANCY
Can cause fetal harm — avoid; effective contraception during and 30 days after.
FDA category + note
Top interactionssee all 5
  • Drugs Causing Capillary LeakSevereDatabaseKimi deep-research + Cla
  • Live VaccinesSevereDatabaseKimi deep-research + Cla
  • Nephrotoxic DrugsSevereDatabaseKimi deep-research + Cla

Mechanism

Recombinant single-chain anti-CD22 Fv fused to truncated Pseudomonas exotoxin A (PE38) — binds CD22 on B-cell leukaemic blasts, is internalised, and the exotoxin moiety ADP-ribosylates eEF2 to halt protein synthesis and induce apoptosis.

Indications

Relapsed/refractory hairy cell leukaemia (after ≥2 prior systemic therapies including a purine nucleoside analog)

Dosing

Adult
40 mcg/kg IV over 30 min on days 1, 3, 5 of each 28-day cycle, for up to 6 cycles or until response.
Pediatric
Not established.
Renal adjustment
No adjustment for CrCl ≥30; not studied below.
Hepatic adjustment
No specific adjustment.
Geriatric
Higher AE risk; monitor closely.
Max dose
40 mcg/kg IV per dose day (days 1, 3, 5 per 28-day cycle)

Pharmacokinetics

Onset
Cytoreduction over cycles
Peak effect
End of infusion (serum)
Duration
28-day cycle
Half-life
~2 h (rapid clearance; immunogenicity reduces exposure over cycles)
Bioavailability
IV 100%
Protein binding
Not applicable
Metabolism
Proteolytic catabolism
Excretion
Catabolised (not excreted intact)

Contraindications

  • Severe hypersensitivity to moxetumomab
  • Caution: prior haemolytic-uraemic syndrome / capillary-leak history

Side effects

Common
Infusion reactionsOedema (peripheral / facial)NauseaFatigueHeadachePyrexiaHypertension
Serious
  • Capillary leak syndrome (boxed)
  • Haemolytic uraemic syndrome (boxed)
  • Severe infusion / hypersensitivity reactions
  • Renal failure
  • Severe electrolyte / coagulation abnormalities

Pregnancy & lactation

Pregnancy

Can cause fetal harm — avoid; effective contraception during and 30 days after.

Lactation

Avoid breastfeeding during therapy.

Drug interactions

Drugs Causing Capillary Leak
Severe
Database

Additive capillary leak

Premedicate; monitor weight / albumin / BP

Source: Kimi deep-research + Cla

Live Vaccines
Severe
Database

Immunosuppression

Avoid live vaccines

Source: Kimi deep-research + Cla

Nephrotoxic Drugs
Severe
Database

Additive renal injury + HUS risk

Avoid; monitor renal function

Source: Kimi deep-research + Cla

Antithrombotic Drugs
Moderate
Database

HUS / thrombocytopenia + bleeding risk

Monitor platelets / coagulation

Source: Kimi deep-research + Cla

Other Myelosuppressive Chemotherapy
Moderate
Database

Additive marrow suppression

Per protocol monitoring

Source: Kimi deep-research + Cla

Related guidelines

Ask House about moxetumomab pasudotox-tdfk

Continue into a citation-backed clinical answer with the drug context already attached.

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