Moxetumomab pasudotox-tdfk

What is Moxetumomab pasudotox-tdfk?

• Moxetumomab pasudotox-tdfk (Lumoxiti) is a CD22-directed cytotoxin used to treat adults with hairy cell leukemia (HCL).

What are the uses of this medicine?

This medicine is used to treat adults with hairy cell leukemia (HCL)

• that has come back or has not responded to previous treatment, and
• have received at least 2 other treatments, including a type of medicine called purine nucleoside analog (PNA).

How does this medicine work?

• A recombinant immunotoxin consisting of the Fv portion of the anti-CD22 antibody covalently fused to a 38 KDa fragment of Pseudomonas exotoxin-A (PE38) with potential antineoplastic activity.
• The Fv portion of anti-CD22 immunotoxin CAT-8015 binds to CD22, a cell surface receptor expressed on a variety of malignant B cells, thereby delivering the toxin moiety PE38 directly to tumor cells.
• Once internalized, PE38 induces caspase-mediated apoptosis via a mechanism involving mitochondrial damage and blocks translational elongation by binding to elongation factor 2 (EF-2).
• Moxetumomab pasudotox-tdfk exhibits a greater affinity for CD22 than its predecessor, anti-CD22 immunotoxin CAT-3888 (BL22 immunotoxin), and hence may be more effective against tumor cells expressing lower levels of CD22.

Who Should Not Use this medicine ?

Limitations of Use

• Not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Lumoxiti .

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Premedicate 30-90 minutes prior to each Lumoxiti infusion with:

• An antihistamine (e.g., hydroxyzine or diphenhydramine)
• Acetaminophen antipyretic
• A histamine-2 receptor antagonist (e.g., ranitidine, famotidine, or cimetidine)
• If a severe infusion related reaction occurs, interrupt the Lumoxiti infusion and institute appropriate medical management. Administer an oral or intravenous corticosteroid approximately 30 minutes before resuming, and before each Lumoxiti infusion thereafter.

Recommended Dosage

• The recommended dose of Lumoxiti is 0.04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Continue Lumoxiti treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity.

• Maintain adequate hydration throughout treatment.
• Consider low-dose aspirin on Days 1 to 8 of each 28-day cycle.

Administration

• Your healthcare provider will give you Lumoxiti into your vein through an intravenous (IV) line over 30 minutes.
• Lumoxiti is usually given on Day 1, Day 3, and Day 5 of a 28-day treatment cycle. This is 1 treatment cycle. You may receive up to 6 treatment cycles.
• Your healthcare provider will give you medicines and IV fluids before and after your infusions.
• It is important for you to drink the additional prescribed amount of fluids (water, milk, or juice) of up to twelve 8-oz glasses every 24 hours on Days 1 through 8 of each 28-day treatment cycle when you receive Lumoxiti infusions.
• Your healthcare provider will decide how many treatment cycles you need.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 1 mg lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.

This medicine is available in fallowing brand namesː

• Lumoxiti

What side effects can this medication cause?

The most common side effects of this medicine include:

• swelling in your face, arms, or legs
• nausea
• feeling tired
• headache
• fever
• constipation
• low red blood cells (anemia)
• diarrhea

Lumoxiti can cause serious side effects, including:

• Kidney problems
• Infusion reactions
• Electrolyte problems

What special precautions should I follow?

• Capillary leak syndrome (CLS), including life-threatening cases, has been reported among patients treated with Lumoxiti and is characterized by hypoalbuminemia, hypotension, symptoms of fluid overload, and hemoconcentration. Monitor patient weight and blood pressure prior to each Lumoxiti infusion and as clinically indicated during treatment. Assess patients for signs and symptoms of CLS, including weight gain (increase in 5.5 pounds (2.5 kg) or ≥ 5% from Day 1 of current cycle), hypotension, peripheral edema, shortness of breath or cough, and pulmonary edema and/or serosal effusions.
• Hemolytic Uremic Syndrome (HUS), including life threatening cases, has been reported in patients treated with Lumoxiti and is characterized by the triad of microangiopathic hemolytic anemia, thrombocytopenia, and progressive renal failure. Avoid Lumoxiti in patients with prior history of severe thrombotic microangiopathy (TMA) or HUS.
• Renal toxicity has been reported in patients treated with Lumoxiti therapy. Monitor for changes in renal function prior to each infusion and as clinically indicated. Delay dosing until recovery.
• Infusion related reactions occurred in patients treated with Lumoxiti. Pre-medicate and if a severe infusion related reaction occurs, interrupt the Lumoxiti infusion and institute appropriate medical management.
• Monitor serum electrolytes prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in non-pregnant female animals, Lumoxiti is expected to cause maternal and embryo-fetal toxicity when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: moxetumomab pasudotox-tdfk
• Inactive ingredients: glycine, polysorbate 80, sodium phosphate monobasic monohydrate, sucrose, and sodium hydroxide
• Inactive ingredients of IV Solution Stabilizer: citric acid monohydrate, polysorbate 80, sodium citrate dihydrate, Water for Injection, USP

Who manufactures and distributes this medicine?

Distributed by: Innate Pharma Inc., Rockville

• Manufactured by: Innate Pharma Inc., Rockville

What should I know about storage and disposal of this medication?

• Refrigerate Lumoxiti and IV Solution Stabilizer at 2°C to 8°C (36°F to 46°F), in original carton to protect from light.
• Do not freeze.
• Do not shake.

• Dailymed label info on Moxetumomab pasudotox-tdfk
• FDA Moxetumomab pasudotox-tdfk

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