INLEXZO
Generic Name/API: gemcitabine intravesical system
Manufacturer: Janssen Biotech, Inc
Dosage Forms & Strength & Pack Size:
One single-dose 225 mg gemcitabine intravesical system
Storage:
Store in the original carton at 20 °C to 25 °C (68 °F to 77 °F); with excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].
INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer
(NMIBC) with carcinoma in situ(CIS) with or without papillary tumors.
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 under certain conditions. ( 5.3)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.4, 8.1, 8.3)
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