JELMYTO

AbsorptionThe systemic exposure of mitomycin following instillation of up to 60 mg of mitomycin as JELMYTO into the pyelocalyceal system was evaluated pre-instillation and hourly for up to six hours post-instillation in six patients. The concentrations of mitomycin in plasma were variable and ranged from 2.43 to 12.80 ng/mL over the course of treatment; the mean C max was 6.24 ng/mL, which is estimated to be less than 1% of the expected C max after intravenous administration.

EliminationFollow...

The efficacy of JELMYTO is based on the results of the Olympus study (NCT02793128), an open-label, single-arm, multicenter trial that enrolled 71 patients with treatment-naïve or recurrent non-invasive low-grade upper tract urothelial cancer (LG-UTUC) with at least one measurable papillary tumor 5 to ≤ 15 mm located above the ureteropelvic junction; patients who had larger tumors could have had tumor debulking prior to treatment, in order to meet the criteria. Patients were excluded from the trial for a history of carcinoma in situ (CIS) in the urinary tract, invasive urothelial carcinoma with...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Ureteric Obstruction [see Warnings and Precautions (5.1) ] Bone Marrow Suppression [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 20%) are ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, nausea, abdominal pain, fatigue, dysuria, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Phar...

JELMYTO is contraindicated in patients with perforation of the bladder or upper urinary tract. Perforation of the bladder or upper urinary tract. ( 4 )

Ureteric Obstruction: Ureteric obstruction may occur. Monitor patients for signs and symptoms of ureteric obstruction. Transient or long-term ureteral stents or alternative procedures may be required. Withhold or permanently discontinue JELMYTO based on the severity of the ureteric obstruction. ( 5.1 ) Bone Marrow Suppression: Thrombocytopenia and neutropenia may occur. Monitor blood counts. Withhold or permanently discontinue JELMYTO based on the severity. ( 5.2 ) Embryo-Fetal Toxicity: Can cau...