Nursing Best Practices for Moxetumomab Pasudotox-tdfk, a New Treatment for Hairy Cell Leukemia

November 2019 Vol 10, No 11
Kathleen Reed, RN, MS, AOCNS
AstraZeneca, Gaithersburg, MD
Cynthia Elesinmogun, PharmD
AstraZeneca, Gaithersburg, MD
Sheetal Desai, PharmD, BCOP
AstraZeneca, Gaithersburg, MD

Background: Hairy cell leukemia (HCL) is a rare B-cell malignancy, diagnosed in ~1000 new patients a year in the US.1 Purine nucleoside analogs (PNAs) are the recommended first-line treatment; however, 30% to 40% of patients relapse within 5 to 10 years of treatment,2 when PNAs become less effective and are associated with cumulative toxicity. Moxetumomab pasudotox-tdfk is a CD22-directed cytotoxin that was FDA approved in 2018 for adults with relapsed/refractory HCL who received ≥2 prior systemic therapies, including a PNA.

Objectives: To educate oncology nurses about the mechanism of action, clinical profile, and best practices for proactive management and monitoring of patients receiving moxetumomab pasudotox-tdfk.

Methods: Approval of moxetumomab pasudotox-tdfk was based on a multicenter, single-arm, open-label phase 3 trial (NCT01829711) in 80 patients with relapsed/refractory HCL.

Results: The objective response rate was 75%, with 41% of patients achieving a complete response (CR) and 30% achieving a durable CR.3 The most common nonlaboratory-based adverse reactions (≥20%) were infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea. Laboratory abnormalities were also observed. The most common grade 3/4 adverse reactions (≥5%) were hypertension, febrile neutropenia, and hemolytic uremic syndrome (HUS), with HUS the most frequent reaction leading to discontinuation (5%).4

It is recommended that moxetumomab pasudotox-tdfk be administered at 0.04 mg/kg/dose as a 30-minute intravenous infusion on days 1, 3, and 5 of each 28-day cycle, for a maximum of 6 cycles, until disease progression or unacceptable toxicity.4 To maintain adequate hydration, patients should receive isotonic fluids (up to 1 L) intravenously before and after each infusion. Patients are advised to hydrate during days 1-8 of each cycle (up to 3 L of fluids/day). Recommended premedications are histamine receptor antagonists, antihistamines, and acetaminophen. To reduce thrombosis risk, low-dose aspirin should be considered on days 1-8. During the 24 hours postinfusion, antihistamines and acetaminophen should be considered, as well as oral corticosteroids to decrease nausea and vomiting. A proactive approach should be taken to monitor for and manage adverse events, including capillary leak syndrome, HUS, renal toxicity, infusion-related reactions, and laboratory abnormalities.

Conclusions: Oncology nurses may have limited knowledge of moxetumomab pasudotox-tdfk because it is a first-in-class molecule, which was recently approved for relapsed/refractory HCL. Strategies for nurses to support high-quality care will be emphasized.

Funding: Supported by AstraZeneca.


  1. Troussard X, Cornet E. Hairy cell leukemia 2018: Update on diagnosis, risk-stratification, and treatment. Am J Hematol. 2017;92(12):1382-1390.
  2. Teras LR, DeSantis CE, Cerhan JR, et al. US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016;66(6):443-459.
  3. Kreitman RJ, Dearden C, Zinzani PL, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018;32(8):1768-1777.
  4. LUMOXITI [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018.
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