The two most common adverse reactions (AR) were urinary frequency (48%) and urinary tract infection (UTI) (44%)1

  • Serious ARs occurred in 24% of patients receiving INLEXZO™1
  • Serious ARs that occurred in >2% of patients included UTI, hematuria, pneumonia, and urinary tract pain1
  • Fatal ARs occurred in 1.2% of patients (n=1) who received INLEXZO™, including cognitive disorder1

Most common ARs occurring in >15% of patients1

Adverse ReactionINLEXZO™
(N=85*)
All Grades
(%)		Grades 3 or 4
(%)
Urinary frequency480
Urinary tract infection446
Dysuria420
Micturition urgency340
Urinary tract pain267
Hematuria242.4
Bladder irritation160
Other clinically significant ARs (<15%) included fatigue (14%), genital pain (12%), diarrhea (11%), urinary incontinence (9%), urinary retention (7%), and nocturia (4.7%).1

Select laboratory abnormalities (>15%) that worsened from baseline1

Laboratory AbnormalityINLEXZO™†
All Grades
(%)		Grades 3 or 4
(%)
Hematology
Decreased hemoglobin311.2
Decreased lymphocytes244.8
Chemistry
Increased lipase2812
Increased creatinine240
Increased potassium221.2
Increased AST171.2
Decreased sodium164.8
Increased ALT161.2

Additional safety information2

  • ARs resolved after a median of ~2.5 weeks (range: 1-126.7+ weeks)

Duration of ARs was defined as the time from onset of ARs to resolution of event or clinical cutoff date if event was ongoing.

This was an analysis of ARs occurring in >15% of patients.

Disclaimer: This information is not in the Prescribing Information. It is being provided for descriptive purposes; results require cautious interpretation.

BCG, Bacillus Calmette–Guérin; CIS, carcinoma in situ; NMIBC, non–muscle invasive bladder cancer.

*The safety of INLEXZO™ monotherapy was evaluated in Cohort 2 of SunRISe-1, a multi-center, open-label study in 85 adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.1

†The denominator used to calculate the rate varied from 82 to 83 based on the number of patients with a baseline value and at least one posttreatment value.1

7% of patients permanently discontinued due to ARs1

ARs which resulted in permanent treatment discontinuation (>1%) included1:

  • Bladder irritation
  • Hydronephrosis
  • Urinary frequency
  • Urinary tract disorder
  • Cognitive disorder
  • Bladder irritation
  • Urinary frequency
  • Cognitive disorder
  • Hydronephrosis
  • Urinary tract disorder

41% of patients experienced dosage interruptions due to ARs1

  • ARs requiring dosage interruption in >3% of patients included UTI, urinary tract pain, hematuria, urinary frequency, micturition urgency, dysuria, and genital pain

The median number of doses of INLEXZO™ administered to patients was 9 doses (range: 1-14 doses)

The median duration of exposure to INLEXZO™ was 41 weeks (range: 1-108 weeks)

Additional information for patients1

Fluid intake

Instruct patients to drink approximately 1500 mL/6-7 cups of fluid per day during therapy with INLEXZO™ to ensure adequate urine production for drug release.

Prophylactic antibiotics

Prophylactic antibiotics may be used at the discretion of the treating healthcare provider with each INLEXZO™ insertion and removal.

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References: 1. INLEXZO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.