Jelmyto Generic Name & Formulations
Mitomycin 40mg/vial; lyophilized pwd for pyelocalyceal soln after reconstitution; contains mannitol.
Single-dose carton—1 (2 vials + 1 vial vehicle gel)
Treatment of low-grade upper tract urothelial cancer.
Jelmyto Dosage and Administration
Prior to each instillation, instruct patient to take 1.3g of oral sodium bicarbonate the evening prior to, the morning of, and 30mins before the procedure (total of 3.9g). Instill 4mg/mL via ureteral catheter or a nephrostomy tube as a chilled soln once weekly for 6 weeks. Total instillation volume (based on pyelography measurements): max 15mL (60mg). For those with a complete response 3 months after initiation, may administer Jelmyto once a month for a max of 11 additional instillations.
Perforation of the bladder or upper urinary tract.
Jelmyto Boxed Warnings
For pyelocalyceal use only. Monitor for ureteric obstruction, flank pain, fever, renal function changes. Withhold or permanently discontinue based on severity of ureteric obstruction. Bone marrow suppression. Obtain platelets, WBC with differential, hemoglobin prior to each treatment. Withhold for Grade 2 thrombocytopenia or neutropenia; permanently discontinue if Grade ≥3 develops. Severe renal impairment (GFR <30mL/min): avoid. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Jelmyto Adverse Reactions
Ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, vomiting; lab abnormalities.
Jelmyto Clinical Trials
Jelmyto Patient Counseling