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Lumoxiti

moxetumomab pasudotox
CD22-Directed CytotoxinFDA Approved 2018AstraZeneca
Route
IV
Half-Life
~1 hr
FDA Approved
2018
Manufacturer
AstraZeneca
1. Indications and Usage

Adults with R/R hairy cell leukemia after 2+ prior systemic therapies including a purine nucleoside analog.

2. Dosage and Administration

40 mcg/kg IV on Days 1, 3, 5 of each 28-day cycle.

3. Dosage Forms and Strengths

Injection: 1 mg lyophilized powder in single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Capillary Leak Syndrome: Life-threatening. Monitor albumin before each dose.
  • Hemolytic Uremic Syndrome: Fatal HUS reported. Monitor renal function and platelets.
  • Renal Toxicity: Ensure adequate hydration.
  • Infusion-Related Reactions: Premedicate.
6. Adverse Reactions
Most Common Adverse Reactions

Peripheral Edema (39%), Nausea (35%), Fatigue (34%), Headache (33%), Pyrexia (33%), Infusion Reactions (25%), Hypoalbuminemia (22%)

Peripheral Edema
39%
Nausea
35%
Fatigue
34%
Headache
33%
Pyrexia
33%
Infusion Reactions
25%
Hypoalbuminemia
22%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies conducted.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Moxetumomab pasudotox is a CD22-directed cytotoxin: an anti-CD22 antibody fragment fused to truncated Pseudomonas exotoxin. Upon internalization, it inhibits protein synthesis causing cell death.

Pharmacokinetics

Half-life: ~1.4 hours. Anti-drug antibodies develop by Cycle 3.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Moxetumomab Pasudotox Trials on ClinicalTrials.gov ↗ 📚 PubMed: Moxetumomab Pasudotox Clinical Trials ↗
FDA-Approved Tumor Types

Lumoxiti has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Hairy Cell Leukemia
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Lumoxiti. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Lumoxiti (moxetumomab pasudotox) approved for?

Lumoxiti (moxetumomab pasudotox) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Lumoxiti (moxetumomab pasudotox) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Lumoxiti (moxetumomab pasudotox) work?

Moxetumomab pasudotox is a CD22-directed cytotoxin: an anti-CD22 antibody fragment fused to truncated Pseudomonas exotoxin. Upon internalization, it inhibits protein synthesis causing cell death.

What are the most common side effects?

Peripheral Edema (39%), Nausea (35%), Fatigue (34%), Headache (33%), Pyrexia (33%), Infusion Reactions (25%), Hypoalbuminemia (22%) Peripheral Edema 39% Nausea 35% Fatigue 34% Headache 33% Pyrexia 33% Infusion Reactions 25% Hypoalbuminemia 22%

← All TherapiesFull Prescribing Information ↗