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Jelmyto Generic Name & Formulations
Legal Class
Rx
General Description
Mitomycin 40mg/vial; lyophilized pwd for pyelocalyceal soln after reconstitution; contains mannitol.
Pharmacological Class
Alkylating agent.
How Supplied
Single-dose carton—1 (2 vials + 1 vial vehicle gel)
Manufacturer
Generic Availability
NO
Jelmyto Indications
Indications
Treatment of low-grade upper tract urothelial cancer.
Jelmyto Dosage and Administration
Adult
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.
Children
Not established.
Jelmyto Contraindications
Contraindications
Perforation of the bladder or upper urinary tract.
Jelmyto Boxed Warnings
Not Applicable
Jelmyto Warnings/Precautions
Warnings/Precautions
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 Pharmacokinetics
See Literature
Jelmyto Interactions
Not Applicable
Jelmyto Adverse Reactions
Adverse Reactions
Ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, vomiting; lab abnormalities.
Jelmyto Clinical Trials
See Literature
Jelmyto Note
Not Applicable
Jelmyto Patient Counseling
See Literature
