Moxetumomab Pasudotox Tdfk
Pronunciation: (loo-MOX-i-tee).
- Generic name
- moxetumomab pasudotox-tdfk
- Brand names
- Lumoxiti, Pasudotox, Moxetum
- Drug class
- Antineoplastic agent; CD22-directed cytotoxin
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What moxetumomab pasudotox-tdfk 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-tdfk works
Lumoxiti (moxetumomab pasudotox-tdfk) is a recombinant immunotoxin targeting CD22, a cell surface antigen expressed on malignant B-cells in hairy cell leukemia. The drug consists of an anti-CD22 monoclonal antibody fragment fused to a truncated Pseudomonas exotoxin. Upon binding to CD22, the immunotoxin is internalized, and the exotoxin inhibits protein synthesis, leading to apoptotic cell death. (1)
What moxetumomab pasudotox-tdfk is used for
Hairy cell leukemia (HCL)
Hairy cell leukemia (HCL) (2)
Relapsed or refractory hairy cell leukemia (HCL)
Relapsed or refractory hairy cell leukemia (HCL) (2)
Hairy cell leukemia (HCL) after at least two prior systemic therapies, including a purine analog
Hairy cell leukemia (HCL) after at least two prior systemic therapies, including a purine analog (2)
Before taking moxetumomab pasudotox-tdfk
Do not take / not appropriate for
- Hypersensitivity to moxetumomab pasudotox-tdfk or any excipients. (Contraindication) (2)
- Use is not recommended in patients with active severe infections or significant renal impairment (CrCl. (Contraindication) (2)
Tell your clinician about
(2)How to take moxetumomab pasudotox-tdfk
- REGULATORY NOTE: Lumoxiti was withdrawn from the US market (distribution halted August 2023) for commercial reasons, not safety or efficacy. The dosing detail below describes how it was used while available, for informational/historical purposes.. General Instructions: Lumoxiti was administered as an intravenous infusion by a healthcare professional. It was not taken by mouth or self-administered.. Adult Dosing: The recommended dose was 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. A specific hydration and pre-medication protocol was required: 1 L of IV fluid before and after each infusion (0.5 L if body weight under 50 kg), up to 3 L of oral fluids daily on Days 1-8 of each cycle, and premedication with an antihistamine, acetaminophen, and an H2-blocker 30-90 minutes before infusion.. Pediatric Dosing: Safety and efficacy in children under 18 years were not established; not recommended for pediatric use.. Administration: Infusions were given in a hospital or clinic, with close monitoring of weight, blood pressure, and kidney function before each dose.. If Severe Side Effects Occurred: Treatment was stopped for disease progression, unacceptable toxicity (including any hemolytic uremic syndrome, or significant capillary leak syndrome), or after completion of 6 cycles — this decision was always made by the treating oncologist, never by the patient alone.. Storage (when the product was in distribution): refrigerated 2-8°C (36-46°F), protected from light, handled and prepared by healthcare professionals only; patients did not store this medication at home.
- 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
Lumoxiti was administered by a healthcare professional on a fixed treatment schedule; if a dose was missed, the treating team would decide how to proceed. Patients did not attempt to make up a missed dose themselves.
Overdose
In case of overdose, emergency medical attention was required. Supportive care and monitoring for toxicity, especially capillary leak syndrome and hemolytic uremic syndrome, were 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
REGULATORY STATUS — serious
Symptoms: REGULATORY STATUS: Lumoxiti was permanently withdrawn from the US market in 2023. AstraZeneca stated this was a business decision related to low clinical uptake and the complexity of safely administering the drug, not a new safety or efficacy finding. It is presented here for informational/historical purposes only.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
BOXED WARNING (FDA), two components — serious
Symptoms: BOXED WARNING (FDA), two components: (1) Capillary Leak Syndrome (CLS) — including life-threatening cases, occurred in about 34% of patients in trials; can present as rapid weight gain, swelling, low blood pressure, and breathing difficulty; monitored closely by the treating team with weight and blood-pressure checks before each dose. (2) Hemolytic Uremic Syndrome (HUS) — including life-threatening cases, occurred in about 7% of patients; involves red blood cell breakdown, low platelets, and worsening kidney function; treatment was discontinued if HUS occurred, on the treating clinician's decision.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Serious infections — serious
Symptoms: Serious infections: increased risk due to low white blood cell counts. Infusion-related reactions: occurred in about half of patients in trials (most commonly nausea, fever, and chills); reduced with premedication. Renal impairment: kidney toxicity occurred in about 26% of patients (higher risk age 65+ or with pre-existing kidney impairment); kidney function was checked before every infusion. Electrolyte abnormalities occurred in over half of patients in trials (low calcium most common); electrolytes were monitored before each dose.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Precautions recorded in the clinician database — serious
Symptoms: Precautions recorded in the clinician database: hypersensitivity to moxetumomab pasudotox-tdfk or any excipients; use was not recommended in patients with active severe infections or significant renal impairment (CrCl <29 mL/min). Caution was used in patients with pre-existing renal dysfunction or a history of thrombotic microangiopathy.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | No significant drug-drug interactions have been identified, but caution is advised with other nephrotoxic agents and immunosuppressants. Always inform your healthcare provider about all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Lumoxiti is expected to cause harm to a developing fetus, based on its mechanism of action as a protein-synthesis-inhibiting toxin — animal reproduction studies were not conducted, but the risk is inferred from how the drug works. Anyone of reproductive potential was advised to use effective contraception during treatment and for at least 30 days after the final dose, and pregnancy status was verified before starting treatment. (2)
Breastfeeding
Women were advised not to breastfeed during Lumoxiti treatment, because of the potential for serious adverse effects in a nursing infant. (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 and effectiveness in children under 18 were not established. (2)
Renal_impairment
No dose adjustment was needed for mild-to-moderate renal impairment (creatinine clearance 30-89 mL/min). Lumoxiti was not recommended in severe renal impairment (creatinine clearance 29 mL/min or less), because its behavior in the body at that level of kidney function was unknown. Kidney function was checked before every infusion. (2)
Hepatic_impairment
No dose adjustment was needed for mild-to-moderate renal impairment (creatinine clearance 30-89 mL/min). Lumoxiti was not recommended in severe renal impairment (creatinine clearance 29 mL/min or less), because its behavior in the body at that level of kidney function was unknown. Kidney function was checked before every infusion. (2)
Monitoring
(2)Storage
When the product was in distribution: unopened vials were refrigerated at 2-8°C (36-46°F), protected from light, not frozen or shaken; reconstituted solution was used immediately; diluted solution was kept at room temperature up to 4 hours or refrigerated up to 24 hours, protected from light. Handled and prepared by healthcare professionals only.
Professional information
Clinician-facing context only. This section does not replace current product labeling. Lumoxiti has been withdrawn from the US market since 2023; this section is retained for informational/historical and clinician-education purposes.
General — FDA label (historical; product withdrawn from US market 2023)
Indication: Hairy cell leukemia (HCL)
Dose summary: 0.04 mg/kg IV infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle, for up to 6 cycles or until disease progression or unacceptable toxicity. NOTE: this replaces the DB's original 'once weekly for 3 weeks, then 1 week off' figure, which did not match the FDA label or the DB's own administration-section text.
Renal context: No dose adjustment needed for CrCl 30-89 mL/min; not recommended for CrCl <=29 mL/min (pharmacokinetics unknown). (2)
Frequently asked questions
Is Lumoxiti still available?
No. Lumoxiti was withdrawn from the US market by AstraZeneca, with distribution halted in August 2023. The manufacturer said this was a business decision due to low clinical uptake and the complexity of administering the drug safely, not a new safety or efficacy concern. Anyone considering hairy cell leukemia treatment should ask their oncologist about currently available options.
What was Lumoxiti used for?
While available, Lumoxiti was used to treat adults with relapsed or refractory hairy cell leukemia (HCL) who had received at least two prior treatments, including a purine nucleoside analog.
How is Lumoxiti given?
Lumoxiti is given as an intravenous infusion by a healthcare professional in a hospital or clinic setting.
What are the most serious side effects of Lumoxiti?
The most serious side effects include capillary leak syndrome, hemolytic uremic syndrome, severe infections, and infusion-related reactions.
Can Lumoxiti be used in children?
No, Lumoxiti is not recommended for use in children under 18 years, as safety and efficacy have not been established.
Do I need to take any special precautions while on Lumoxiti?
Yes, stay well hydrated, monitor for signs of infection or swelling, and attend all scheduled blood tests and appointments.
What should I do if I miss a dose?
Lumoxiti was given by a healthcare professional on a fixed schedule; a missed appointment would be handled by the treating team. Patients did not attempt to self-administer or reschedule a dose on their own.
Can I receive vaccines while on Lumoxiti?
You should avoid live vaccines during treatment with Lumoxiti. Discuss all vaccinations with your healthcare provider.
What happens if I take too much Lumoxiti?
Taking too much Lumoxiti can lead to an increased risk of severe side effects, including infusion-related reactions, capillary leak syndrome, and hemolytic uremic syndrome. Symptoms may include fever, chills, difficulty breathing, swelling, and kidney problems. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Do not attempt to self-treat an overdose.
Can I drink alcohol while taking Lumoxiti?
It is generally advisable to avoid or limit alcohol consumption while taking Lumoxiti. Alcohol can potentially exacerbate certain side effects associated with antineoplastic agents, such as liver toxicity or gastrointestinal issues. Furthermore, alcohol may interfere with the body's ability to recover from treatment. Always consult your healthcare provider for personalized advice regarding alcohol intake during your treatment with Lumoxiti.
Is Lumoxiti safe during pregnancy?
Lumoxiti's safety during pregnancy has not been established, and it falls under a pregnancy category that requires careful consideration. Due to its mechanism of action as a cytotoxin, there is a potential for harm to a developing fetus. Therefore, it is strongly recommended that pregnant individuals or those planning to become pregnant consult their healthcare provider to discuss the risks and benefits before initiating or continuing treatment with Lumoxiti.
What is the mechanism of action of moxetumomab pasudotox-tdfk?
Lumoxiti (moxetumomab pasudotox-tdfk) is a recombinant immunotoxin targeting CD22, a cell surface antigen expressed on malignant B-cells in hairy cell leukemia. The drug consists of an anti-CD22 monoclonal antibody fragment fused to a truncated Pseudomonas exotoxin. Upon binding to CD22, the immunotoxin is internalized, and the exotoxin inhibits protein synthesis, leading to apoptotic cell death. (1)
What is the generic name of Moxetumomab Pasudotox Tdfk?
The generic name is moxetumomab pasudotox-tdfk. It is sold under brand names including Lumoxiti, Pasudotox, Moxetum.
What class of drug is moxetumomab pasudotox-tdfk?
Moxetumomab Pasudotox Tdfk is classed as: Antineoplastic agent; CD22-directed cytotoxin.
References
- Lumoxiti — MedGuideGlobal clinician-authored medicine recordMedGuideGlobal · United States · accessed 2026-08-06 · source 1
- LUMOXITI (moxetumomab pasudotox-tdfk) injection, for intravenous use — prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-06 · source 2
- Manufacturer announces permanent withdrawal of Lumoxiti from the US marketAstraZeneca (reporting via OncLive, Blood Cancers Today, CURE, Oncology Nursing News, CancerNetwork, Medscape) · United States · dated 2023-07 · accessed 2026-08-06 · source 3
- Moxetumomab Pasudotox-tdfk Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- moxetumomab pasudotox-tdfk — RxNorm normalized drug concept (RXCUI 2099305)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient moxetumomab pasudotox-tdfk names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.