Limitations to the study include its retrospective nature and sample size. The complications and adverse event profile of the antegrade administration of Jelmyto were contingent on patient reporting, and thus may have been underreported. While the multi-institutional nature of the study may support generalizability of the safety profile, varying practice patterns and pathologic analysis may have contributed to confounding. Similarly, the tertiary urologic oncology centers administering Jelmyto percutaneously may have missed adverse events if patients presented to community hospitals for complications. Compared to the OLYMPUS Study, in which the safety analysis group contained 71 patients, this study is smaller in that it only includes the findings from 4 tertiary institutions that were administering Jelmyto through the antegrade method. Larger-scale clinical trials are needed to inform clinical decision-making concerning patients with UTUC.
In Jelmyto's phase 3 OLYMPUS Study, ureteric stenosis was observed in 44% of patients, all of whom received Jelmyto via the retrograde route of administration.
Jelmyto is approved for the treatment of adults with low-grade UTUC (LG-UTUC). The authors report that the study included 3 patients with high-grade UTUC (HG-UTUC), and the authors also note potential adjuvant use of Jelmyto in the treatment of LG-UTUC. UroGen Pharma does not recommend Jelmyto for any use other than in adults with LG-UTUC. The safety and efficacy of Jelmyto for the treatment of HG-UTUC, or as an adjuvant to a different primary therapy for the treatment of LG-UTUC, have not been established.
Jelmyto® (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
Jelmyto is contraindicated in patients with perforation of the bladder or upper urinary tract.
Ureteric obstruction, including ureteral stenosis and hydronephrosis, occurred in patients receiving Jelmyto. Monitor patients for signs and symptoms of ureteric obstruction, including flank pain, and fever, and for changes in renal function. Patients who experience obstruction may require transient or long-term ureteral stents or alternative procedures. Withhold or permanently discontinue Jelmyto based on the severity of ureteric obstruction.
The use of Jelmyto can result in bone marrow suppression, particularly thrombocytopenia and neutropenia. The following tests should be obtained prior to each treatment: Platelet count, white blood cell count differential and hemoglobin. Withhold JELMYTO for Grade 2 thrombocytopenia or neutropenia. Permanently discontinue for Grade 3 or greater thrombocytopenia or neutropenia.
Based on findings in animals and mechanism of action, Jelmyto can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with Jelmyto and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Jelmyto and for 3 months following the last dose.
The most common adverse reactions in ≥ 20% of patients treated with Jelmyto were ureteric obstruction, flank pain, urinary tract infection, hematuria, abdominal pain, fatigue, renal dysfunction, nausea, dysuria, and vomiting.
Selected clinically relevant adverse reactions in < 10% and ≥ 2% of patients who received Jelmyto include urinary tract inflammation, bladder spasm, urosepsis, hypersensitivity, and instillation site pain.
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Jelmyto and for 1 week following the last dose.
Jelmyto is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration. Jelmyto must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the Jelmyto Instructions for Pharmacy and administration instructions found in the Jelmyto Instructions for Administration.
Jelmyto may discolor urine to a violet to blue color following the instillation procedure. Advise patients to avoid contact with urine for at least six hours post-instillation, to void urine sitting on a toilet, and to flush the toilet several times after use.
Jelmyto is a hazardous drug. Follow applicable special handling and disposal procedures.
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