ZUSDURI
Generic: MITOMYCIN
Basic Information
Manufacturer
UroGen Pharma, Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
8dc68793-bca8-4e3d-b672-622961b58255
Indications & Usage
1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
( 1 )
ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Pharma at 1-855-987-6436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
The safety of ZUSDURI was evaluated in ENVISION, a single-arm, multicenter study in 240 patients with recurrent LG-IR-NMIBC [see Clinical Studies (14) ].
Patients received 75 mg ZUSDURI instilled once a week for 6 consecutive weeks.
The median number of doses of ZUSDURI administered to patients was 6 (range 1-6) doses and 228 patients (95%) received all six scheduled doses.
Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including urinary retention (0.8%) and urethral stenosis (0.4%).
A fatal adverse reaction of cardiac failure occurred in 1 patient (0.4%) receiving ZUSDURI.
Permanent discontinuation of ZUSDURI due to an adverse reaction occurred in 2.9% of patients, including 1.7% who discontinued due to a renal or urinary disorder.
Dosage interruption of ZUSDURI due to adverse reactions occurred in 10% of patients.
Adverse reactions (≥ 2%) which required dosage interruption were urinary tract infection (2.5%) and dysuria (2.5%).
The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
Table 1 summarizes the adverse reactions in ENVISION.
Table 1: Adverse Reactions (≥ 10% All Grades Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
) in Patients Who Received ZUSDURI in ENVISION Adverse Reaction ZUSDURI N = 240 All Grades (%) Grade 3 or 4 Only includes Grade 3 adverse reactions (%) Renal and urinary disorders Dysuria 23 0.4 Hematuria Includes multiple related terms 10 0 Infections and infestations Urinary tract infection 12 0.8 Clinically relevant adverse reactions occurring in < 10% of patients receiving ZUSDURI in ENVISION included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethral stenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanoposthitis, and nocturia.
Table 2 summarizes laboratory abnormalities in ENVISION.
Table 2: Laboratory Abnormalities (≥ 10% All Grades Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
) That Worsened From Baseline in Patients Who Received ZUSDURI in ENVISION Laboratory Abnormality ZUSDURI The denominator used to calculate the rate varied from 227 to 238 based on the number of patients with a baseline value and at least one post-treatment value All Grades (%) Grade 3 or 4 Only includes Grade 3 laboratory abnormalities (%) Hematology Hemoglobin Decreased 17 0.8 Eosinophils Increased 15 0 Lymphocytes Decreased 14 0.4 Neutrophils Decreased 10 0.4 Chemistry Creatinine Increased 29 1.3 Potassium Increased 26 2.2 Aspartate Aminotransferase (AST) Increased 15 0.4 Alanine Aminotransferase (ALT) Increased 15 0.4
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Pharma at 1-855-987-6436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
The safety of ZUSDURI was evaluated in ENVISION, a single-arm, multicenter study in 240 patients with recurrent LG-IR-NMIBC [see Clinical Studies (14) ].
Patients received 75 mg ZUSDURI instilled once a week for 6 consecutive weeks.
The median number of doses of ZUSDURI administered to patients was 6 (range 1-6) doses and 228 patients (95%) received all six scheduled doses.
Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including urinary retention (0.8%) and urethral stenosis (0.4%).
A fatal adverse reaction of cardiac failure occurred in 1 patient (0.4%) receiving ZUSDURI.
Permanent discontinuation of ZUSDURI due to an adverse reaction occurred in 2.9% of patients, including 1.7% who discontinued due to a renal or urinary disorder.
Dosage interruption of ZUSDURI due to adverse reactions occurred in 10% of patients.
Adverse reactions (≥ 2%) which required dosage interruption were urinary tract infection (2.5%) and dysuria (2.5%).
The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
Table 1 summarizes the adverse reactions in ENVISION.
Table 1: Adverse Reactions (≥ 10% All Grades Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
) in Patients Who Received ZUSDURI in ENVISION Adverse Reaction ZUSDURI N = 240 All Grades (%) Grade 3 or 4 Only includes Grade 3 adverse reactions (%) Renal and urinary disorders Dysuria 23 0.4 Hematuria Includes multiple related terms 10 0 Infections and infestations Urinary tract infection 12 0.8 Clinically relevant adverse reactions occurring in < 10% of patients receiving ZUSDURI in ENVISION included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethral stenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanoposthitis, and nocturia.
Table 2 summarizes laboratory abnormalities in ENVISION.
Table 2: Laboratory Abnormalities (≥ 10% All Grades Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
) That Worsened From Baseline in Patients Who Received ZUSDURI in ENVISION Laboratory Abnormality ZUSDURI The denominator used to calculate the rate varied from 227 to 238 based on the number of patients with a baseline value and at least one post-treatment value All Grades (%) Grade 3 or 4 Only includes Grade 3 laboratory abnormalities (%) Hematology Hemoglobin Decreased 17 0.8 Eosinophils Increased 15 0 Lymphocytes Decreased 14 0.4 Neutrophils Decreased 10 0.4 Chemistry Creatinine Increased 29 1.3 Potassium Increased 26 2.2 Aspartate Aminotransferase (AST) Increased 15 0.4 Alanine Aminotransferase (ALT) Increased 15 0.4