Moxetumomab pasudotox-tdfk (Lumoxiti) — Clinical FAQs

Question 1

What is Moxetumomab pasudotox-tdfk FDA-approved to treat?

Accepted Answer

Moxetumomab pasudotox-tdfk is FDA-approved for the following oncology indications: 1. Relapsed or refractory hairy cell leukemia (HCL) in adults who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog (Lumoxiti; FDA approved September 2018 based on the pivotal Study 1053). NOTE: AstraZeneca voluntarily withdrew Lumoxiti from the US market in July 2023 for commercial reasons unrelated to safety or efficacy — the drug is no longer commercially available in the United States..

Question 2

How does Moxetumomab pasudotox-tdfk work (mechanism of action)?

Accepted Answer

Moxetumomab pasudotox is a CD22-directed recombinant immunotoxin. It consists of the disulfide-stabilized variable fragment (dsFv) of a high-affinity murine anti-CD22 monoclonal antibody genetically fused to PE38, a 38-kDa truncated fragment of Pseudomonas aeruginosa exotoxin A. CD22 is a B-lineage-restricted sialoglycoprotein expressed at high density on hairy cells and most B-cell malignancies. After the antibody moiety binds CD22, the complex is rapidly internalized and trafficked to the endosome, where the PE38 fragment is processed and translocates to the cytosol. There, PE38 catalyzes the ADP-ribosylation of diphthamide on eukaryotic elongation factor 2 (eEF2), irreversibly inactivating eEF2 and arresting protein synthesis. The resulting shutdown of translation triggers apoptotic cell death. This antigen-directed delivery of a bacterial toxin allows potent killing of CD22-expressing leukemic cells while largely sparing CD22-negative tissues, and is effective independent of BRAF mutation status.

Question 3

How is Moxetumomab pasudotox-tdfk administered?

Accepted Answer

Moxetumomab pasudotox-tdfk is administered Intravenous (IV). Recommended dose: 0.

Question 4

What are the most common side effects of Moxetumomab pasudotox-tdfk?

Accepted Answer

The most commonly reported side effects of Moxetumomab pasudotox-tdfk (≥10% incidence) include: Peripheral edema and fluid overload (~39%), Nausea (~35%), Fatigue (~36%), Headache (~33%), Pyrexia / fever (~31%) and others (14 total). Consult your oncologist for complete prescribing information.

Question 5

Does Moxetumomab pasudotox-tdfk have a black box warning?

Accepted Answer

Yes. Moxetumomab pasudotox-tdfk carries FDA black box warning(s) regarding: 1. Capillary leak syndrome (CLS): Moxetumomab pasudotox can cause CLS, which may be life-threatening or fatal. CLS is characterized by hypoalbuminemia, hypotension, symptoms of fluid overload, weight gain, and hemoconcentration. Monitor weight, blood pressure, and albumin; assess for fluid overload before and during treatment. Withhold or discontinue and provide supportive management (IV fluids/albumin, corticosteroids) as clinically indicated. 2. Hemolytic uremic syndrome (HUS): Moxetumomab pasudotox can cause HUS, which may be life-threatening or fatal. HUS is defined by the triad of microangiopathic hemolytic anemia, thrombocytopenia, and progressive renal insufficiency. Monitor hemoglobin, platelets, serum creatinine, and LDH. Ensure adequate hydration; withhold or permanently discontinue for HUS and manage supportively.

Question 6

Is Moxetumomab pasudotox-tdfk safe during pregnancy?

Accepted Answer

Moxetumomab pasudotox-tdfk pregnancy safety: No adequate human data. Based on its mechanism of action and animal findings, moxetumomab pasudotox may cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for at least 30 days after the final dose. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for at least 30 days after the last dose.. Oncologists should review the complete prescribing information and discuss reproductive risks with patients before initiating therapy.

Moxetumomab pasudotox-tdfk — Drug Monograph

Mechanism of Action

FDA Indications

Common Side Effects

Clinical Pearl

Related Therapies & Mechanisms