Moxetumomab Pasudotox
Pronunciation: (mox-eh-TOO-moh-mab pah-SOO-doh-tox).
- Generic name
- Moxetumomab pasudotox
- Brand names
- Lumoxiti, Pasudotox, Moxetum
- Drug class
- Cancer & Oncology
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What Moxetumomab pasudotox is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Moxetumomab pasudotox works
Moxetumomab pasudotox is a recombinant immunotoxin composed of an anti-CD22 monoclonal antibody fragment fused to a truncated form of Pseudomonas exotoxin A. It binds specifically to CD22, a cell surface antigen expressed on malignant B-cells in hairy cell leukemia. Upon binding, the immunotoxin is internalized, and the exotoxin fragment inhibits protein synthesis by ADP-ribosylating elongation factor 2, leading to apoptotic cell death.
What Moxetumomab pasudotox is used for
Historical FDA-approved indication (drug now discontinued): relapsed or refractory hairy cell leukemia (HCL) after at least 2 prior systemic therapies including a purine nucleoside analog
This was the FDA-approved indication while Lumoxiti was commercially available (2018-2023 in the US). It is no longer an available treatment option; ask your oncologist about current alternatives for relapsed/refractory HCL. (2)
Before taking Moxetumomab pasudotox
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to moxetumomab pasudotox or any excipients. (Contraindication) (2)
- Not recommended in pregnancy or breastfeeding due to potential fetal harm. (Contraindication) (2)
Tell your clinician about
(2)How to take Moxetumomab pasudotox
- General Instructions: Lumoxiti is administered as an intravenous infusion by a healthcare professional. Do not attempt to self-administer this medication.. Adult Dosing: The recommended dose is 0.04 mg/kg given as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle, for up to 6 cycles or until disease progression or unacceptable toxicity.. Pediatric Dosing: Safety and efficacy in children under 18 years have not been established; Lumoxiti is not recommended for pediatric use.. Administration: Administered in a healthcare setting. Patients should be well-hydrated before and after each infusion to reduce the risk of kidney problems.. When To Stop: If severe or life-threatening side effects such as capillary leak syndrome or severe kidney impairment developed, the treating oncologist would stop treatment.. Storage: Healthcare professionals stored and prepared Lumoxiti. It was kept refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light until use.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a scheduled infusion, contact your healthcare provider immediately to reschedule. Do not attempt to make up the dose on your own.
Overdose
In case of suspected overdose, seek emergency medical attention. Overdose may increase the risk of severe side effects such as capillary leak syndrome, kidney injury, and infusion reactions. Supportive care and monitoring are essential. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Capillary leak syndrome
Incidence: Reported in the clinician-authored database; frequency not established
Hemolytic uremic syndrome
Incidence: Reported in the clinician-authored database; frequency not established
Infusion-related reactions
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Fatigue
Incidence: Reported in the clinician-authored database; frequency not established
Peripheral edema
Incidence: Reported in the clinician-authored database; frequency not established
Pyrexia
Incidence: Reported in the clinician-authored database; frequency not established
Hypoalbuminemia
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
CURRENT AVAILABILITY — serious
Symptoms: CURRENT AVAILABILITY: Lumoxiti was permanently discontinued in the United States (effective August 2023) and its EU marketing authorisation was withdrawn (2021) — both for commercial reasons, not new safety findings. It is not currently obtainable as a prescription option in these regions. Anyone researching hairy cell leukemia treatment should ask their oncologist about currently available therapies.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
FDA BOXED WARNING (while the drug was marketed) — serious
Symptoms: FDA BOXED WARNING (while the drug was marketed): Capillary leak syndrome (CLS), including life-threatening cases, occurred in patients receiving Lumoxiti — symptoms included difficulty breathing, sudden weight gain, low blood pressure, and swelling of the arms, legs, or face, requiring immediate medical attention. Hemolytic uremic syndrome (HUS), including life-threatening cases, also occurred; treatment was discontinued in patients who developed HUS. This was the highest level of warning the FDA assigns to a medicine.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Capillary leak syndrome is a potentially life-threatening complication—seek immediate care if symptoms develop — serious
Symptoms: Capillary leak syndrome is a potentially life-threatening complication—seek immediate care if symptoms develop. Monitor for kidney problems; report decreased urination or swelling promptly. Serious infusion reactions may occur, especially during or shortly after administration. Risk of hemolytic uremic syndrome (HUS); monitor for signs of anemia, bruising, or kidney dysfunction. Not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to moxetumomab pasudotox or any excipients. Use with caution in patients with pre-existing renal impairment, history of capillary leak syndrome, or those at risk for hemolytic uremic syndrome. Not recommended in pregnancy or breastfeeding due to potential fetal harm.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | There are no well-documented drug-drug interactions with Lumoxiti, but caution is advised when used with nephrotoxic agents or medications that may increase the risk of capillary leak syndrome. Always inform your healthcare provider about all medicines, including over-the-counter drugs and supplements. |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Not recommended during pregnancy due to the potential for fetal harm from this cytotoxin-based medicine, per the clinician-authored record. This medicine is no longer commercially available; historical information is provided for reference only. (2)
Breastfeeding
Not recommended during breastfeeding due to the potential for infant harm, per the clinician-authored record. This medicine is no longer commercially available; historical information is provided for reference only. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (2)
Renal_impairment
Use with caution in patients with pre-existing renal impairment, per the clinician-authored record; specific numeric renal/hepatic dose-adjustment data was not identified in the sources reviewed. This medicine is no longer commercially available. (2)
Hepatic_impairment
Use with caution in patients with pre-existing renal impairment, per the clinician-authored record; specific numeric renal/hepatic dose-adjustment data was not identified in the sources reviewed. This medicine is no longer commercially available. (2)
Monitoring
(2)Storage
Healthcare professionals stored and prepared Lumoxiti; it was kept refrigerated at 2-8C (36-46F) and protected from light until use. Not applicable to new prescriptions, as the medicine is no longer commercially distributed.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General (historical — drug discontinued)
Indication: Hairy cell leukemia (HCL)
Dose summary: Historical dosing while available: 0.04 mg/kg IV infusion over 30 minutes on Days 1, 3, and 5 of a 28-day treatment cycle. This medicine is no longer commercially distributed in the US or EU.
Renal context: Use with caution in pre-existing renal impairment, per the clinician-authored record; specific numeric renal-impairment dose-adjustment data was not identified in the sources reviewed. (2)
Frequently asked questions
What is Lumoxiti used for?
Lumoxiti is no longer commercially available (discontinued in the US in August 2023 and never marketed in the EU after its authorisation was withdrawn in 2021, both for commercial rather than safety reasons). While it was available, it was used to treat adults with relapsed or refractory hairy cell leukemia (HCL) who had received at least two prior systemic therapies, including a purine nucleoside analog. Ask your oncologist about currently available treatment options.
How does Lumoxiti work?
Lumoxiti targets the CD22 protein on cancerous B-cells, delivering a toxin that destroys these cells while sparing most healthy cells.
What are the most serious side effects of Lumoxiti?
The most serious side effects include capillary leak syndrome, kidney problems, hemolytic uremic syndrome, and severe infusion reactions.
Can Lumoxiti be used in children?
No, the safety and effectiveness of Lumoxiti in children under 18 years have not been established.
How is Lumoxiti administered?
Lumoxiti is given as an intravenous infusion by a healthcare professional, typically over 30 minutes on Days 1, 3, and 5 of a 28-day cycle.
What should I do if I miss a dose?
Contact your healthcare provider immediately to reschedule. Do not attempt to self-administer or make up the dose.
Can I take other medications with Lumoxiti?
Always inform your healthcare provider about all medications and supplements you are taking, as interactions may occur, especially with drugs affecting the kidneys.
What happens if I take too much Lumoxiti (Moxetumomab pasudotox)?
Taking too much Lumoxiti (Moxetumomab pasudotox) can lead to an exacerbation of side effects, potentially including severe capillary leak syndrome, renal toxicity, and hemolytic uremic syndrome. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Healthcare providers will manage symptoms and provide supportive care.
Can I drink alcohol while taking Lumoxiti (Moxetumomab pasudotox)?
It is generally advisable to avoid or limit alcohol consumption while undergoing treatment with Lumoxiti (Moxetumomab pasudotox). Alcohol can potentially worsen certain side effects, such as liver toxicity or fatigue, which may already be associated with antineoplastic agents. Always consult your healthcare provider for personalized advice regarding alcohol intake during your treatment.
Is Lumoxiti (Moxetumomab pasudotox) safe during pregnancy?
The safety of Lumoxiti (Moxetumomab pasudotox) during pregnancy has not been established, and it is categorized as 'Consult doctor' regarding pregnancy risk. Due to its mechanism of action as a cytotoxin, there is a potential for harm to a developing fetus. Pregnant individuals or those who may become pregnant should discuss the risks and benefits thoroughly with their healthcare provider before initiating or continuing treatment.
What is the mechanism of action of Moxetumomab pasudotox?
Moxetumomab pasudotox is a recombinant immunotoxin composed of an anti-CD22 monoclonal antibody fragment fused to a truncated form of Pseudomonas exotoxin A. It binds specifically to CD22, a cell surface antigen expressed on malignant B-cells in hairy cell leukemia. Upon binding, the immunotoxin is internalized, and the exotoxin fragment inhibits protein synthesis by ADP-ribosylating elongation factor 2, leading to apoptotic cell death.
What is the generic name of Moxetumomab Pasudotox?
The generic name is Moxetumomab pasudotox. It is sold under brand names including Lumoxiti, Pasudotox, Moxetum.
What class of drug is Moxetumomab pasudotox?
Moxetumomab Pasudotox is classed as: Cancer & Oncology.
References
- Lumoxiti (Moxetumomab pasudotox) — clinician-authored medicine recordMedGuideGlobal · Global (internal clinician-authored content) · accessed 2026-08-06 · source 1
- LUMOXITI (moxetumomab pasudotox-tdfk) injection, powder, lyophilized, for solution — discontinued productU.S. National Library of Medicine DailyMed / FDA · United States · dated 2023 · accessed 2026-08-06 · source 2
- Public statement — LUMOXITI (moxetumomab pasudotox) Withdrawal of marketing authorisation in the European UnionEuropean Medicines Agency · European Union · dated 2021-07-23 · accessed 2026-08-06 · source 3
- LUMOXITI (MOXETUMOMAB PASUDOTOX) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION IV STABILIZER (POLYSORBATE 80) SOLUTION [INNATE PHARMA, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 4
- Moxetumomab Pasudotox-tdfk Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 5
- Moxetumomab pasudotox — RxNorm normalized drug concept (RXCUI 2099295)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient Moxetumomab pasudotox names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.