HELPING PATIENTS ACCESS THE CARE THEY NEED

The InnateCaresTM program provides personal support to connect patients to affordability programs and streamline access and reimbursement for LUMOXITI. InnateCares provides:

  • Assistance with understanding patient insurance coverage and pharmacy options
  • Prior authorization support
  • Claims and appeal process support

To learn more about the InnateCares program, please call 1-844-694-6628 Monday – Friday, 8 AM – 8 PM EST

Connect Your LUMOXITI Patients to Affordability Options

Find the right affordability options for your patients

ACCESS AND REIMBURSEMENT

InnateCaresTM offers a range of resources to help support your patients and your practice once you prescribe LUMOXITI.

LUMOXITI Enrollment Form

A multi-page enrollment form to capture necessary patient, provider, and prescription information to start a new request for support.

DOWNLOAD HERE >

LUMOXITI Coding Resource

This resource provides specific codes related to diagnosing and billing for LUMOXITI.

DOWNLOAD HERE >

LUMOXITI Distribution Sheet

This piece provides a contact list of specialty pharmacy providers and specialty distributors that handle LUMOXITI.

DOWNLOAD HERE >

LUMOXITI Affordability Brochure

This piece provides information for those patients seeking affordability for their LUMOXITI medication.

DOWNLOAD HERE >

LUMOXITI Co-pay Savings Program

The LUMOXITI Co-pay Savings Program helps assist eligible, commercially insured patients with out-of-pocket costs.

Who can apply?

  • Patients who are covered by commercial insurance, and their insurance does not cover the full cost of their prescription
  • Residents of the United States or Puerto Rico
  • You are ineligible if prescriptions are paid by any state or Federally funded programs, including but not limited to, Medicare Part B, Medicare Part D, Medicaid, Medigap, Veterans Affairs, Department of Defense, or TRICARE
  • Patients with a valid prescription to accompany the LUMOXITI Co-pay Savings Program offer

What to know

What happens once an eligible patient is enrolled in the LUMOXITI Co-pay Savings Program?
A Co-pay Savings Program account will be created for the eligible patient. This can be done by the pharmacy/practice or by calling an InnateCares representative. Once enrolled, the patient will continue to pay a set amount of his or her out-of-pocket costs for LUMOXITI. The pharmacy/practice will use the Co-pay Savings Program to cover the balance, up to the program maximum.

What are the specific costs associated with the LUMOXITI Co-pay Savings Program?
The patient pays $0 per infusion, program pays remaining out-of-pocket costs up to a maximum of $26,000 per year. The out-of-pocket costs covered by the program can include the cost of the product itself and/or the cost of infusion of the product (program maximum of $100 per infusion assistance). Patients who are residents of Massachusetts, Michigan, Minnesota, or Rhode Island are not eligible for infusion assistance.

What does the LUMOXITI Co-pay Savings Program cover?
The LUMOXITI Co-pay Savings Program covers the cost of the drug and administration but does not cover costs for office visits or any other associated costs.

Are there income requirements to participate in the program?
No. There are no income requirements to participate in the program.

Where can I find additional information?
For additional information, please call an InnateCares representative at 1-844-694-6628 Monday – Friday, 8 AM – 8 PM EST.

Patient Assistance Program

Our Patient Assistance Program provides LUMOXITI at no cost, if you qualify.

Who can apply?

  • People without health insurance
  • Medicare Part D and/or B recipients
  • Those who have recently experienced a financial crisis
  • Legal residents of the United States or Puerto Rico

What to know

Eligibility rules apply, please call an InnateCares representative for more information at 1-844-694-6628

Independent Patient Assistance Foundations

Assistance may be available through independent foundations such as those listed below. Foundations can provide a variety of assistance types: co-pay, transportation, premium, patient education, etc.

Who can apply?

These foundations are not associated with Innate Pharma; specific details and eligibility requirements can be found directly at the foundations’ websites.

Patient Access Network Foundation
www.PANfoundation.org
1-866-316-7263

Good Days Fund
www.mygooddays.org
1-877-968-7233

Patient Advocate Foundation
www.patientadvocate.org
1-800-532-5274

HealthWell Foundation
www.healthwellfoundation.org
1-800-675-8416

CancerCare Co-Payment Assistance Foundation
www.cancercare.org
1-866-552-6729

The Assistance Fund
www.theassistancefund.org
1-855-845-3663

Leukemia & Lymphoma Society
www.lls.org
1-800-955-4572

Patient Services, Inc.
www.patientservicesinc.org
1-800-366-7741

What to know

For additional information, please call an InnateCares representative at 1-844-694-6628 Monday – Friday, 8 AM – 8 PM EST.

Read More

IMPORTANT SAFETY INFORMATION

WARNING: CAPILLARY LEAK SYNDROME and HEMOLYTIC UREMIC SYNDROME

  • Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving LUMOXITI. Monitor weight and blood pressure; check labs, including albumin, if CLS is suspected. Delay dosing or discontinue LUMOXITI as recommended.
  • Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patients receiving LUMOXITI. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration. Discontinue LUMOXITI in patients with HUS.

WARNINGS AND PRECAUTIONS

  • 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. In the combined safety database of HCL patients treated with LUMOXITI, CLS occurred in 34% (44/129) of patients, including Grade 2 in 23% (30/129), Grade 3 in 1.6% (2/129), and Grade 4 in 2% (3/129).

    Most cases of CLS occurred in the first 8 days (range: 1 to 19) of a treatment cycle, however, cases have also been reported on other days throughout the cycle. The median time to resolution of CLS was 12 days (range: 1 to 53).

    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. In addition, the following changes in laboratory parameters may help identify CLS: hypoalbuminemia, elevated hematocrit, leukocytosis, and thrombocytosis.

    CLS may be life-threatening or fatal if treatment is delayed. Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time. Patients who develop CLS should receive appropriate supportive measures, including concomitant oral or intravenous corticosteroids, and hospitalization as clinically indicated. Withhold LUMOXITI for Grade 2 CLS until resolution, and permanently discontinue for Grade ≥ 3 CLS.

  • 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. In the combined safety database of HCL patients treated with LUMOXITI, HUS occurred in 7% (9/129) of patients, including Grade 3 in 3% (4/129) and Grade 4 in 0.8% (1/129).

    Most cases of HUS occurred in the first 9 days (range: 1 to 16) of a treatment cycle, however, cases have also been reported on other days throughout the cycle. The median time to resolution of HUS was 11.5 days (range: 2 to 44). All cases resolved, including those who discontinued LUMOXITI.

    Avoid LUMOXITI in patients with prior history of severe thrombotic microangiopathy (TMA) or HUS. Administer prophylactic intravenous fluids before and after LUMOXITI infusions. In Study 1053, patients with a platelet count ≥ 100,000/mm3 received low-dose aspirin on Days 1 through 8 of each 28-day cycle for prophylaxis of thrombosis.

    Monitor blood chemistry and complete blood counts prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended. Consider the diagnosis of HUS in patients who develop hemolytic anemia, worsening or sudden onset of thrombocytopenia, increase in creatinine levels, elevation of bilirubin and/or LDH, and have evidence of hemolysis based on peripheral blood smear schistocytes.

    The events of HUS may be life-threatening if treatment is delayed with increased risk of progressive renal failure requiring dialysis. If HUS is suspected initiate appropriate supportive measures, including fluid repletion, hemodynamic monitoring, and consider hospitalization as clinically indicated. Discontinue LUMOXITI in patients with HUS.

  • Renal Toxicity has been reported in patients treated with LUMOXITI therapy. In the combined safety database of HCL patients treated with LUMOXITI, 26% (34/129) reported adverse events of renal toxicity, including acute kidney injury (2.3%), renal failure (2.3%), renal impairment (1.6%), serum creatinine increased (17%), and proteinuria (8%). Grade 3 acute kidney injury occurred in 1.6% (2/129) of patients.

    Based on laboratory findings, during treatment, serum creatinine increased by two or more grades from baseline in 22% (29/129) of patients, including increases of Grade 3 in 1.6% (2/129) of patients. At the end of treatment, serum creatinine levels remained elevated at 1.5- to 3-times the upper limit of normal in 5% of patients. Patients who experience HUS, those ≥ 65 years of age, or those with baseline renal impairment may be at increased risk for worsening of renal function following treatment with LUMOXITI.

    Monitor renal function prior to each infusion of LUMOXITI, and as clinically indicated throughout treatment. Delay LUMOXITI dosing in patients with Grade ≥ 3 elevations in creatinine, or upon worsening from baseline by ≥ 2 grades.

  • Infusion Related Reactions occurred in patients treated with LUMOXITI, and were defined as the occurrence of any one of the following events on the day of study drug infusion: chills, cough, dizziness, dyspnea, feeling hot, flushing, headache, hypertension, hypotension, infusion related reaction, myalgia, nausea, pyrexia, sinus tachycardia, tachycardia, vomiting, or wheezing. In Study 1053, infusion related reactions occurred in 50% (40/80) of patients, including Grade 3 events in 11% (9/80) of patients. The most frequently reported infusion related events were nausea (15%), pyrexia (14%), chills (14%), vomiting (11%), headache (9%), and infusion related reaction (9%).

    Infusion related reactions may occur during any cycle of treatment with LUMOXITI. Premedicate with antihistamines and antipyretics prior to each LUMOXITI dose. 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, or before the next LUMOXITI infusion.

  • Electrolyte Abnormalities: In the combined safety database of HCL patients treated with LUMOXITI, electrolyte abnormalities occurred in 57% (73/129) of patients with the most common electrolyte abnormality being hypocalcemia occurring in 25% of patients. Grade 3 electrolyte abnormalities occurred in 14% (18/129) of patients and Grade 4 electrolyte abnormalities occurred in 0.8% (1/129) of patients. Electrolyte abnormalities co-occurred in the same treatment cycle with CLS, HUS, fluid retention, or renal toxicity in 37% (48/129) of patients.

    Monitor serum electrolytes prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended.

ADVERSE REACTIONS

  • Most common non-laboratory adverse reactions (≥ 20%) of any grade were infusion related reactions (50%), edema peripheral (39%), nausea (35%), fatigue (34%), headache (33%), pyrexia (31%), constipation (23%), anemia (21%), and diarrhea (21%). The most common Grade 3 or 4 adverse reactions (reported in at least ≥ 5% of patients) were hypertension, febrile neutropenia, and HUS.
  • Most common laboratory abnormalities (≥ 20%) of any grade were creatinine increased, ALT increased, hypoalbuminemia, AST increased, hypocalcemia, hypophosphatemia, hemoglobin decreased, neutrophil count decreased, hyponatremia, blood bilirubin increased, hypokalemia, GGT increased, hypomagnesemia, platelet count decreased, hyperuricemia, and alkaline phosphate increased.
  • Adverse reactions resulting in permanent discontinuation of LUMOXITI occurred in 15% (12/80) of patients. The most common adverse reaction leading to LUMOXITI discontinuation was HUS (5%). The most common adverse reaction resulting in dose delays, omissions, or interruptions was pyrexia (3.8%).

SPECIFIC POPULATIONS

  • Pregnancy: There are no available data on LUMOXITI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Advise pregnant women of the potential risk to a fetus.
  • Lactation: Advise women not to breastfeed.
  • Geriatric Use: Exploratory analyses suggest a higher incidence of adverse reactions leading to drug discontinuation (23% versus 7%) and renal toxicity (40% versus 20%) for patients 65 years of age or older as compared to those younger than 65 years.

INDICATION

LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Limitation of Use

LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤29 mL/min).

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide and Instructions for Use.

You may report side effects related to LUMOXITI by calling the Medical Information Call Center 888-501-0998. If you prefer to report these to the FDA, either visit MedWatch or call 1-800-FDA-1088.

Reference:References:

  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. Data on File. REF-34765, AstraZeneca Pharmaceuticals LP.
  3. Kreitman RJ, Dearden C, Zinzani PL, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. Published Online: July 20, 2018 (doi: 10.1038/s41375-018-0210-1).
  4. National Institutes of Health. Moxetumomab pasudotox for advanced hairy cell leukemia. ClinicalTrials.gov Web site.
    https://clinicaltrials.gov/ct2/show/NCT01829711. Accessed July 2, 2018.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. D’Arena G, Musto P, Cascavilla N, Dell’Olio M, Di Renzo N, Carotenuto M. Quantitative flow cytometry for the differential diagnosis of leukemic B-cell chronic lymphoproliferative disorders. Am J Hematol. 2000;64:275-281.
  3. Cesano A, Gayko U. CD22 as a target of passive immunotherapy. Semin Oncol. 2003;30:253-257.
  4. Schneider AK, Vainshtein I, Roskos LK, Chavez C, Sun B, Liang M. An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox. J Immunol Methods. 2016;435:68-76.
  1. Troussard X, Cornet E. Hairy cell leukemia 2018: updated on diagnosis, risk-stratification, and treatment. Am J Hematol. 2017;92(12):1382-1390.
  2. Lopez-Rubio M, Garcia-Marco JA. Current and emerging treatment options for hairy cell leukemia. Onco Targets Ther. 2015;8:2147-2156.
  3. Grever MR, Blachly JS, Andritsos LA. Hairy cell leukemia: Update on molecular profiling and therapeutic advances. Blood Rev. 2014;28(5):197-203.
  4. Zinzani PL, Pellegrini C, Stefoni V, et al. Hairy cell leukemia: evaluation of the long-term outcome in 121 patients. Cancer. 2010;116(20):4788-4792.
  5. Thompson PA, Ravandi F. How I manage patients with hairy cell leukaemia. Br J Haematol. 2017;177(4):543-556.
  6. Arons E, Suntum T, Stetler-Stevenson M, Kreitman RJ. VH4-34+ hairy cell leukemia, a new variant with poor prognosis despite standard therapy. Blood. 2009;114(21):4687-4695.
  7. Maevis V, Mey U, Schmidt-Wolf G, Schmidt-Wolf IG. Hairy cell leukemia: short review, today’s recommendations and outlook. Blood Cancer J. 2014;4:e184.
  8. Else M, Dearden CE, Matutes E, et al. Long-term follow-up of 233 patients with hairy cell leukaemia, treated initially with pentostatin or cladribine, at a median of 16 years from diagnosis. Br J Haematol. 2009;145(6):733-740.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018.
  2. Data on File, XXXXX, AstraZeneca Pharmaceuticals LP.

LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤29 mL/min).

IMPORTANT SAFETY INFORMATION

WARNING: CAPILLARY LEAK SYNDROME and HEMOLYTIC UREMIC SYNDROME

  • Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving LUMOXITI. Monitor weight and blood pressure; check labs, including albumin, if CLS is suspected. Delay dosing or discontinue LUMOXITI as recommended.
  • Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patients receiving LUMOXITI. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration. Discontinue LUMOXITI in patients with HUS.

WARNINGS AND PRECAUTIONS

  • 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. In the combined safety database of HCL patients treated with LUMOXITI, CLS occurred in 34% (44/129) of patients, including Grade 2 in 23% (30/129), Grade 3 in 1.6% (2/129), and Grade 4 in 2% (3/129).

    Most cases of CLS occurred in the first 8 days (range: 1 to 19) of a treatment cycle, however, cases have also been reported on other days throughout the cycle. The median time to resolution of CLS was 12 days (range: 1 to 53).

    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. In addition, the following changes in laboratory parameters may help identify CLS: hypoalbuminemia, elevated hematocrit, leukocytosis, and thrombocytosis.

    CLS may be life-threatening or fatal if treatment is delayed. Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time. Patients who develop CLS should receive appropriate supportive measures, including concomitant oral or intravenous corticosteroids, and hospitalization as clinically indicated. Withhold LUMOXITI for Grade 2 CLS until resolution, and permanently discontinue for Grade ≥ 3 CLS.

  • 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. In the combined safety database of HCL patients treated with LUMOXITI, HUS occurred in 7% (9/129) of patients, including Grade 3 in 3% (4/129) and Grade 4 in 0.8% (1/129).

    Most cases of HUS occurred in the first 9 days (range: 1 to 16) of a treatment cycle, however, cases have also been reported on other days throughout the cycle. The median time to resolution of HUS was 11.5 days (range: 2 to 44). All cases resolved, including those who discontinued LUMOXITI.

    Avoid LUMOXITI in patients with prior history of severe thrombotic microangiopathy (TMA) or HUS. Administer prophylactic intravenous fluids before and after LUMOXITI infusions. In Study 1053, patients with a platelet count ≥ 100,000/mm3 received low-dose aspirin on Days 1 through 8 of each 28-day cycle for prophylaxis of thrombosis.

    Monitor blood chemistry and complete blood counts prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended. Consider the diagnosis of HUS in patients who develop hemolytic anemia, worsening or sudden onset of thrombocytopenia, increase in creatinine levels, elevation of bilirubin and/or LDH, and have evidence of hemolysis based on peripheral blood smear schistocytes.

    The events of HUS may be life-threatening if treatment is delayed with increased risk of progressive renal failure requiring dialysis. If HUS is suspected initiate appropriate supportive measures, including fluid repletion, hemodynamic monitoring, and consider hospitalization as clinically indicated. Discontinue LUMOXITI in patients with HUS.

  • Renal Toxicity has been reported in patients treated with LUMOXITI therapy. In the combined safety database of HCL patients treated with LUMOXITI, 26% (34/129) reported adverse events of renal toxicity, including acute kidney injury (2.3%), renal failure (2.3%), renal impairment (1.6%), serum creatinine increased (17%), and proteinuria (8%). Grade 3 acute kidney injury occurred in 1.6% (2/129) of patients.

    Based on laboratory findings, during treatment, serum creatinine increased by two or more grades from baseline in 22% (29/129) of patients, including increases of Grade 3 in 1.6% (2/129) of patients. At the end of treatment, serum creatinine levels remained elevated at 1.5- to 3-times the upper limit of normal in 5% of patients. Patients who experience HUS, those ≥ 65 years of age, or those with baseline renal impairment may be at increased risk for worsening of renal function following treatment with LUMOXITI.

    Monitor renal function prior to each infusion of LUMOXITI, and as clinically indicated throughout treatment. Delay LUMOXITI dosing in patients with Grade ≥ 3 elevations in creatinine, or upon worsening from baseline by ≥ 2 grades.

  • Infusion Related Reactions occurred in patients treated with LUMOXITI, and were defined as the occurrence of any one of the following events on the day of study drug infusion: chills, cough, dizziness, dyspnea, feeling hot, flushing, headache, hypertension, hypotension, infusion related reaction, myalgia, nausea, pyrexia, sinus tachycardia, tachycardia, vomiting, or wheezing. In Study 1053, infusion related reactions occurred in 50% (40/80) of patients, including Grade 3 events in 11% (9/80) of patients. The most frequently reported infusion related events were nausea (15%), pyrexia (14%), chills (14%), vomiting (11%), headache (9%), and infusion related reaction (9%).

    Infusion related reactions may occur during any cycle of treatment with LUMOXITI. Premedicate with antihistamines and antipyretics prior to each LUMOXITI dose. 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, or before the next LUMOXITI infusion.

  • Electrolyte Abnormalities: In the combined safety database of HCL patients treated with LUMOXITI, electrolyte abnormalities occurred in 57% (73/129) of patients with the most common electrolyte abnormality being hypocalcemia occurring in 25% of patients. Grade 3 electrolyte abnormalities occurred in 14% (18/129) of patients and Grade 4 electrolyte abnormalities occurred in 0.8% (1/129) of patients. Electrolyte abnormalities co-occurred in the same treatment cycle with CLS, HUS, fluid retention, or renal toxicity in 37% (48/129) of patients.

    Monitor serum electrolytes prior to each dose and on Day 8 of each treatment cycle. Monitoring mid-cycle is also recommended.

ADVERSE REACTIONS

  • Most common non-laboratory adverse reactions (≥ 20%) of any grade were infusion related reactions (50%), edema peripheral (39%), nausea (35%), fatigue (34%), headache (33%), pyrexia (31%), constipation (23%), anemia (21%), and diarrhea (21%). The most common Grade 3 or 4 adverse reactions (reported in at least ≥ 5% of patients) were hypertension, febrile neutropenia, and HUS.
  • Most common laboratory abnormalities (≥ 20%) of any grade were creatinine increased, ALT increased, hypoalbuminemia, AST increased, hypocalcemia, hypophosphatemia, hemoglobin decreased, neutrophil count decreased, hyponatremia, blood bilirubin increased, hypokalemia, GGT increased, hypomagnesemia, platelet count decreased, hyperuricemia, and alkaline phosphate increased.
  • Adverse reactions resulting in permanent discontinuation of LUMOXITI occurred in 15% (12/80) of patients. The most common adverse reaction leading to LUMOXITI discontinuation was HUS (5%). The most common adverse reaction resulting in dose delays, omissions, or interruptions was pyrexia (3.8%).

SPECIFIC POPULATIONS

  • Pregnancy: There are no available data on LUMOXITI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Advise pregnant women of the potential risk to a fetus.
  • Lactation: Advise women not to breastfeed.
  • Geriatric Use: Exploratory analyses suggest a higher incidence of adverse reactions leading to drug discontinuation (23% versus 7%) and renal toxicity (40% versus 20%) for patients 65 years of age or older as compared to those younger than 65 years.

INDICATION

LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Limitation of Use

LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤29 mL/min).

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide and Instructions for Use.

You may report side effects related to LUMOXITI by calling the Medical Information Call Center 888-501-0998. If you prefer to report these to the FDA, either visit MedWatch or call 1-800-FDA-1088.

Reference:References:

  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. Data on File. REF-34765, AstraZeneca Pharmaceuticals LP.
  3. Kreitman RJ, Dearden C, Zinzani PL, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. Published Online: July 20, 2018 (doi: 10.1038/s41375-018-0210-1).
  4. National Institutes of Health. Moxetumomab pasudotox for advanced hairy cell leukemia. ClinicalTrials.gov Web site.
    https://clinicaltrials.gov/ct2/show/NCT01829711. Accessed July 2, 2018.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. D’Arena G, Musto P, Cascavilla N, Dell’Olio M, Di Renzo N, Carotenuto M. Quantitative flow cytometry for the differential diagnosis of leukemic B-cell chronic lymphoproliferative disorders. Am J Hematol. 2000;64:275-281.
  3. Cesano A, Gayko U. CD22 as a target of passive immunotherapy. Semin Oncol. 2003;30:253-257.
  4. Schneider AK, Vainshtein I, Roskos LK, Chavez C, Sun B, Liang M. An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox. J Immunol Methods. 2016;435:68-76.
  1. Troussard X, Cornet E. Hairy cell leukemia 2018: updated on diagnosis, risk-stratification, and treatment. Am J Hematol. 2017;92(12):1382-1390.
  2. Lopez-Rubio M, Garcia-Marco JA. Current and emerging treatment options for hairy cell leukemia. Onco Targets Ther. 2015;8:2147-2156.
  3. Grever MR, Blachly JS, Andritsos LA. Hairy cell leukemia: Update on molecular profiling and therapeutic advances. Blood Rev. 2014;28(5):197-203.
  4. Zinzani PL, Pellegrini C, Stefoni V, et al. Hairy cell leukemia: evaluation of the long-term outcome in 121 patients. Cancer. 2010;116(20):4788-4792.
  5. Thompson PA, Ravandi F. How I manage patients with hairy cell leukaemia. Br J Haematol. 2017;177(4):543-556.
  6. Arons E, Suntum T, Stetler-Stevenson M, Kreitman RJ. VH4-34+ hairy cell leukemia, a new variant with poor prognosis despite standard therapy. Blood. 2009;114(21):4687-4695.
  7. Maevis V, Mey U, Schmidt-Wolf G, Schmidt-Wolf IG. Hairy cell leukemia: short review, today’s recommendations and outlook. Blood Cancer J. 2014;4:e184.
  8. Else M, Dearden CE, Matutes E, et al. Long-term follow-up of 233 patients with hairy cell leukaemia, treated initially with pentostatin or cladribine, at a median of 16 years from diagnosis. Br J Haematol. 2009;145(6):733-740.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI® (moxetumomab pasudotox-tdfk) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  1. LUMOXITI [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018.
  2. Data on File, XXXXX, AstraZeneca Pharmaceuticals LP.

LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤29 mL/min).

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