INLEXZO

The systemic exposure of gemcitabine and the inactive uracil metabolite (2´-deoxy-2´,2´-difluorouridine [dFdU]), were evaluated between Days 2 and 7 during the indwelling period. The plasma gemcitabine concentrations were below the lower limit of quantification (0.1 µg/mL) in all patients at all time points. Eighteen patients (17%) had at least one quantifiable plasma dFdU concentration above the lower limit of quantification (0.1 µg/mL) and the maximum observed plasma dFdU concentration was 0.4...

14.1 BCG-unresponsive NMIBC The efficacy of INLEXZO was evaluated in Cohort 2 of SunRISe-1 (NCT04640623), a single-arm, multi-center trial in 83 adults with BCG-unresponsive, NMIBC with CIS, with or without papillary tumors (T1, or high-grade Ta) following transurethral resection. BCG-unresponsive NMIBC CIS was defined as persistent or recurrent CIS alone or with Ta/T1 disease within 12 months of adequate BCG therapy. Adequate BCG therapy was defined as a minimum administration of at least five of six doses of an initial induction course plus either of: at least two of three doses of maintenan...

The most common (>15%) adverse reactions, including laboratory abnormalities, are urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088...

INLEXZO is contraindicated in patients with: Perforation of the bladder [see Warnings and Precautions (5.1) ] . Prior hypersensitivity reactions to gemcitabine or any component of the product. Perforation of the bladder ( 4 , 5.1 ) Prior hypersensitivity reaction to gemcitabine or any component of the product ( 4 )

Risks in Patients with Perforated Bladder : Evaluate the bladder before the intravesical insertion of INLEXZO. Do not administer to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised. ( 4 , 5.1 ) Risk of Metastatic Bladder Cancer with Delayed Cystectomy : Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal. ( 5.2 ) Magnetic Resonance Imaging (MRI) Safety : INLEXZO can only be safely scanned with MRI...