Gemcitabine Intravesical

1 INDICATIONS AND USAGE INLEXZO is 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. 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. ( 1 )

6 ADVERSE REACTIONS 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 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, INLEXZO can cause fetal harm when administered to a pregnant woman if systemic exposure occurs [see Clinical Pharmacology (12.1) ] . There are no available data on the use of INLEXZO in pregnant women to inform a drug-associated risk. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S.

5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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 )