Moxetumomab Pasudotox

Moxetumomab pasudotox is a prescription medication indicated for adults with relapsed or refractory hairy cell leukemia who have received at least 2 prior systemic therapies, including a purine nucleoside analog. Planned permanent discontinuation fom US market is August 31, 2023.

• Moxetumomab pasudotox is available under the following different brand names: Lumoxiti, Moxetumomab pasudotox-tdfk

Common side effects of Moxetumomab pasudotox include:

• infusion-related reactions
• fluid retention (including facial swelling, abdominal bloating, weight gain, and swelling of extremities)
• nausea
• fatigue
• headache
• fever
• constipation
• anemia
• diarrhea
• eye problems (blurred vision, dry eye, cataracts, eye discomfort or pain, eye swelling, conjunctivitis, and tearing)

Serious side effects of Moxetumomab pasudotox include:

• hypertension
• febrile neutropenia
• hemolytic uremic syndrome

Rare side effects of Moxetumomab pasudotox include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and geriatric dosage

Injection, lyophilized powder for reconstitution

• 1 mg/single-use vial
• The date of planned permanent discontinuation from the US market is August 31, 2023

Hairy Cell Leukemia

Adult dosage

• 0.04 mg/kg IV on days 1, 3, and 5 of each 28-day cycle; infuse over 30 minutes
• Continue for a maximum of 6 cycles or until disease progression or unacceptable toxicity occurs
• Recommended concomitant treatment
• Hydration
  • Administer 1 L of isotonic solution (eg, D5W plus 0.45% or 0.9% NaCl) IV over 2-4 hr before and after each moxetumomab pasudotox infusion; administer 0.5 L for patients with weight less than 50 kg
  • Additionally, adequately hydrate with up to 3 L of oral fluids (eg, water, milk, juice) per 24 hr on Days 1 through 8 of each 28-day cycle (up to 2 L if weight less than 50 kg)
  • Monitor fluid balance and serum electrolytes to avoid fluid overload and/or electrolyte abnormalities
• Thromboprophylaxis
  • Consider low-dose aspirin on Days 1 through 8 of each 28-day cycle
  • Monitor for signs and symptoms of thrombosis
• Premedication
  • Premedicate 30-90 minutes before each moxetumomab pasudotox infusion with an antihistamine (eg, hydroxyzine, diphenhydramine), acetaminophen antipyretic, and a histamine-2 receptor antagonist (eg, ranitidine, famotidine, cimetidine)
• Postinfusion medication
  • Consider oral antihistamines and antipyretics for up to 24 hr after infusion
  • An oral corticosteroid (eg, 4 mg dexamethasone) is recommended to decrease nausea and vomiting
  • Maintain adequate oral fluid intake

Dosage Considerations – Should be Given as Follows:

• See “Dosages”