Expanding kidney-sparing options for patients with low-grade upper tract urothelial cancer

Expanding kidney-sparing options for patients with low-grade upper tract urothelial cancer

Question and Answer

JELMYTO® HCP Important Safety Information

INDICATIONS AND USAGE

JELMYTO® (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

Contraindications

JELMYTO is contraindicated in patients with perforation of the bladder or upper urinary tract.

Ureteric Obstruction

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.

Bone Marrow Suppression

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.

Embryo-Fetal Toxicity

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.

Common Adverse Reactions

The most common adverse reactions in ≥ 20% of patients treated with JELMYTO were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting.

Additional Adverse Reactions Information

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.

Use in Specific Populations
Lactation

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.

Preparation and Administration Information

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 cytotoxic drug. Follow applicable special handling and disposal procedures.

Please see accompanying Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration.

©2020 UroGen Pharma, Inc. All rights reserved.

JEL-HCP-ISI-001

Meet the Speakers

Gordon Brown D.O.

Gordon Brown D.O.

Program Director of Urologic Surgery
Rowan University
School of Osteopathic Medicine
New Brunswick, NJ

Phillip M. Pierorazio, M.D.

Phillip M. Pierorazio, M.D.

Associate Professor of Urology and Oncology
Johns Hopkins University
Baltimore, MD

Program Objectives

Discuss the recent guidelines updates that have expanded the recommended use of kidney-sparing procedures

Review the results of the OLYMPUS trial that evaluates the efficacy and safety of a primary tumor therapy for low-grade upper tract urothelial cancer (LG-UTUC)1

Explain the current limitations of radical nephroureterectomy and endoscopic management

Describe the first and only FDA-approved chemoablative treatment for LG-UTUC, that uses a novel reverse thermal hydrogel technology

Reference

  • Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol. 2020;21(6):776-785. doi:10.1016/S1470-2045(20)30147-9

Please click here for Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration.

UroGen Pharma

JELMYTO is a trademark of UroGen Pharma, Ltd.
© 2020 UroGen Pharma, Inc. All rights reserved.
US-JEL-00258 9/20