Lumoxiti Side Effects Center

Last updated on RxList: 9/1/2020
Lumoxiti Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lumoxiti?

Lumoxiti (moxetumomab pasudotox-tdfk) is a CD22-directed cytotoxin 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).

What Are Side Effects of Lumoxiti?

Common side effects of Lumoxiti include:

  • infusion related reactions,
  • fluid retention (including facial swelling, abdominal bloating, weight gain, 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)

Dosage for Lumoxiti

The recommended dosage of Lumoxiti is 0.04 mg/kg as an intravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle.

What Drugs, Substances, or Supplements Interact with Lumoxiti?

Lumoxiti may interact with other drugs. Tell your doctor all medications and supplements you use.

Lumoxiti During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Lumoxiti; it may harm a fetus. Women of reproductive potential should use contraception during treatment with Lumoxiti and for at least 30 days after the last dose is received. It is unknown if Lumoxiti passes into breast milk. Breastfeeding is not recommended while using Lumoxiti.

Additional Information

Our Lumoxiti (moxetumomab pasudotox-tdfk) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Lumoxiti Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, hot or cold, light-headed, or have a headache, muscle pain, cough, trouble breathing, or fast heartbeats.

Moxetumomab pasudotox can damage red blood cells, which may cause irreversible kidney failure. Get emergency medical help if you have: unusual bruising or bleeding, fever, confusion, tiredness or irritability, stomach pain, vomiting, dark urine, fast heartbeats, and little or no urination.

Call your doctor at once if you have:

  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • signs of an electrolyte imbalance--muscle spasms or contractions, numbness or tingly feeling, nausea, fast or irregular heartbeats, seizure; or
  • capillary leak syndrome--dizziness, weakness, cough, trouble breathing, and sudden swelling or weight gain.

Serious side effects may be more likely in older adults.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • swelling in your arms, legs, or face;
  • nausea, diarrhea, constipation;
  • headache, tiredness;
  • fever; or
  • anemia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Lumoxiti Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

  • Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
  • Hemolytic Uremic Syndrome [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Infusion Related Reactions [see WARNINGS AND PRECAUTIONS]
  • Electrolyte Abnormalities [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described in this section reflect exposure to LUMOXITI in 80 patients with previously treated HCL in Study 1053 [see Clinical Studies]. Patients received LUMOXITI 0.04 mg/kg as an intravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle for a maximum of 6 cycles or until disease progression or unacceptable toxicity.

The median duration of treatment with LUMOXITI was 5.7 months (range: 0.9 to 6.7), with a median of 6 treatment cycles started in each patient.

The most common non-laboratory adverse reactions (≥ 20%) of any grade were infusion related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea. The most common Grade 3 or 4 adverse reactions (reported in at least ≥ 5% of patients) were hypertension, febrile neutropenia, and HUS.

The 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%).

Tables 4 and 5 present the frequency category of adverse reactions and key laboratory abnormalities observed in patients with relapsed or refractory HCL treated with LUMOXITI.

Table 4: Adverse Reactions* in ≥ 20% (All Grades) of Patients with HCL in Study 1053

LUMOXITI
N=80
All Grades (%)Grade 3 (%)
General Disorders and Administration Site Conditions
  Edema peripheral39-
  Fatigue34-
  Pyrexia311.3
Gastrointestinal Disorders
  Nausea352.5
  Constipation23-
  Diarrhea21-
Injury, Poisoning, and Procedural Complications
  Infusion related reactions503.8
Nervous System Disorders
  Headache33-
Blood and Lymphatic System Disorders
  Anemia2110
*Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Infusion related reactions: includes patients who were reported to have one or more infusion event that may be infusion-related on the day of study drug infusion.

Fluid retention occurred in 63% (50/80) of patients treated with LUMOXITI in Study 1053, including Grade 3 in 1.3% (1/80) of patients. Fluid retention included all preferred terms of edema peripheral (39%), face edema (14%), abdominal distension (13%), weight increased (8%), pleural effusion (6%), edema (5%), peripheral swelling (5%), localized edema (3.8%), ascites (1.3%), fluid overload (1.3%), fluid retention (1.3%), and pericardial effusion (1.3%). Of the fifty patients with fluid retention, 29% of patients required diuretics.

Ocular adverse events occurred, including: blurred vision (9%), dry eye (8%), cataracts (5%), ocular discomfort and/or pain (4%), ocular swelling/periorbital edema (4%), conjunctivitis (1.3%), conjunctival hemorrhage (1.3%), and ocular discharge (1.3%).

Table 5: Laboratory Abnormalities* in ≥ 20% (All Grades) Reported in Patients with HCL in Study 1053

LUMOXITI
N=80
All Grades (%)Grade 3 (%)Grade 4 (%)
Hematology
Hemoglobin decreased4315-
Neutrophil count decreased411120
Platelet count decreased21113.8
Chemistry
Creatinine increased962.5-
ALT increased653.8-
Hypoalbuminemia641.3-
AST increased551.3-
Hypocalcemia54--
Hypophosphatemia5314-
Hyponatremia418.8-
Blood Bilirubin increased301.3-
Hypokalemia251.31.3
GGT increased25--
Hypomagnesemia231.3-
Hyperuricemia21-2.5
Alkaline phosphatase increased20--
ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma glutamyl transferase
*Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and based on laboratory measurements worsening from baseline

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to moxetumomab pasudotox-tdfk in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

The immunogenicity of LUMOXITI was evaluated using electrochemiluminescent (ECL)-based immunoassay to test for anti-moxetumomab pasudotox-tdfk antibodies (ADA). For patients whose serum tested positive for ADA, a cell-based assay was performed to detect neutralizing antibodies (nAb). In Study 1053, 59% (45/76) of patients tested positive for ADA prior to any treatment with moxetumomab pasudotox-tdfk. Seventy out of 80 subjects tested ADA positive at any point during the study and were subsequently tested for nAb. The results showed that 67 of 70 subjects were nAb-positive. Among these 67 patients who tested nAb-positive, 99% (66/67) had ADA specific to the PE38 binding domain, and 54% (36/67) also had ADA specific to the CD22 binding domain. In 41 out of 73 patients who had baseline and post-baseline ADA results, the median fold increase from baseline (Cycle 1, Day 1) in ADA titer was 3.75-(range: 0 to 240), 54-(range: 0 to 2560), 120-(range: 0 to 1920), and 128-(range: 0 to 2560) fold at Cycles 2, 3, 5, and end-of-treatment, respectively. Patients who tested positive for ADA had decreased systemic moxetumomab pasudotox-tdfk concentrations [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Lumoxiti (Moxetumomab Pasudotox-tdfk for Injection)

© Lumoxiti Patient Information is supplied by Cerner Multum, Inc. and Lumoxiti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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