Version July 2025
Note: Do NOT substitute mitomycin (ureteral gel) for mitomycin injection or mitomycin (ophthalmic) or vice versa; the products are different and are NOT interchangeable. Mitomycin (ureteral gel) is not for intravesicular use, refer to the Mitomycin (systemic) monograph for information on intravesicular use (off-label route) of mitomycin for injection.
Prior to instillation: Premedicate prior to each instillation with a total of 3.9 g sodium bicarbonate (1.3 g orally the evening prior to, 1.3 g the morning of, and 1.3 g 30 minutes prior to the instillation). Local or general anesthesia, sedation, prophylactic antibiotics, and/or antihistamines may be used as clinically necessary. If anesthesia is to be used, do not administer the final sodium bicarbonate dose. Consider withholding diuretics 1 day prior to instillation until 4 hours post instillation.
Urothelial cancer, low-grade upper tract: Pyelocalyceal instillation: Instill mitomycin (ureteral gel) dose once weekly for 6 weeks via ureteral catheter or nephrostomy tube. In patients with a complete response 3 months after therapy initiation, may then administer mitomycin (ureteral gel) once monthly for a maximum of 11 additional instillations.
Total instillation volume is based on volumetric measurements using pyelography, and should not exceed 15 mL (60 mg of mitomycin). The concentration of reconstituted mitomycin (ureteral gel) is 4 mg/mL.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
GFR ≥30 mL/minute: There are no dosing adjustments provided in the manufacturer's labeling.
GFR <30 mL/minute: Avoid use.
There are no dosing adjustments provided in the manufacturer's labeling.
Hematologic toxicity:
Neutropenia or thrombocytopenia, grade 2: Withhold mitomycin (ureteral gel).
Neutropenia or thrombocytopenia, ≥ grade 3: Permanently discontinue mitomycin (ureteral gel).
Ureteric obstruction: Withhold or permanently discontinue mitomycin (ureteral gel) based on the severity of the obstruction.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Pruritus (13%), skin rash (14%)
Endocrine & metabolic: Hyperkalemia (13%), hypernatremia (11%), hyperuricemia (16%), hypoalbuminemia (28%), hypocalcemia (16%)
Gastrointestinal: Abdominal pain (24%), nausea (25%; grades 3/4: 1%), vomiting (20%; grades 3/4: 4%)
Genitourinary: Dysuria (23%), hematuria (34%), pollakiuria (14%), urethral stricture (44%), urinary tract infection (34%)
Hematologic & oncologic: Anemia (14% to 38%; grades 3/4: 1%), lymphocytopenia (21%; grades ≥3: 3%), thrombocytopenia (21%; grades ≥3: 3%)
Nervous system: Chills (11%), fatigue (24%)
Renal: Decreased estimated GFR (eGFR) (38%), flank pain (41%), hydronephrosis (18%), increased serum creatinine (34%), kidney impairment (25%)
Miscellaneous: Fever (13%)
1% to 10%:
Cardiovascular: Hypertension (10%)
Gastrointestinal: Decreased appetite (10%)
Genitourinary: Bladder spasm (2% to 10%), obstructive uropathy (1%), ureteral obstruction (3%; pelvi-ureteric: 6%), urinary tract abnormality (inflammation: 2% to 10%), urinary tract infection with sepsis (2% to 10%), urinary tract obstruction (7%)
Hematologic & oncologic: Neutropenia (grade 3: 1%)
Hypersensitivity: Hypersensitivity reaction (2% to 10%)
Local: Application-site pain (2% to 10%)
Perforation of the bladder or upper urinary tract.
Concerns related to adverse effects:
• Bone marrow suppression: Mitomycin (ureteral gel) may cause bone marrow suppression, particularly neutropenia and thrombocytopenia (including grade 3 events). In a clinical study, gross extravasation of mitomycin (ureteral gel) through urinary tract perforation or impaired mucosa was not observed in patients experiencing bone marrow suppression. Monitor blood counts prior to each instillation (platelet count, WBC count with differential, and hemoglobin); withhold for grade 2 and permanently discontinue for grade 3 or greater neutropenia or thrombocytopenia.
• Ureteric obstruction: Ureteric obstruction has been reported with mitomycin (ureteral gel), including ureteral stenosis and hydronephrosis. In a small clinical trial, ureteric obstruction was observed in close to 60% of patients; grade 3 obstruction was noted in some patients. The median time to first onset of ureteric obstruction was 72 days (range: 15 to 462 days). Ureteral stent placement, balloon dilation, or nephroureterectomy were required in some patients; in those who required ureteral stent placement, the median duration of indwelling stents was 51 days (range: 1 to 292 days). Ureteric obstruction did not resolve (or resolved with sequelae) in ~50% of patients; some patients experienced grade 1 or 2 serum creatinine increases. Monitor for signs/symptoms of ureteric obstruction, including flank pain and fever, and for changes in renal function. Withhold or permanently discontinue mitomycin (ureteral gel) based on the severity of ureteral obstruction.
Other warnings/precautions:
• Product selection: Mitomycin is available as mitomycin (ureteral gel), mitomycin for injection, and mitomycin (ophthalmic); the products are different and are NOT interchangeable. Verify product label prior to reconstitution and administration to prevent medication errors. Mitomycin (ureteral gel) is not for intravesicular use; refer to the Mitomycin (systemic) monograph for information on intravesicular use (off-label route) of mitomycin for injection.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Ureteral:
Jelmyto: 80 (2 x 40) MG (1 ea) [contains polyethylene glycol (macrogol)]
No
Solution (reconstituted) (Jelmyto Ureteral)
80 (2 x 40) mg (per each): $29,376.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Refer to manufacturer's labeling for administration details. Mitomycin (ureteral gel) is for pyelocalyceal instillation only (via ureteral catheter or nephrostomy tube). Do not administer IV, topically, or orally. When instilling mitomycin (ureteral gel), the entire syringe must be emptied within 1 minute. Reconstituted mitomycin (ureteral gel) must be instilled within 1 hour after it is converted to a viscous liquid.
Premedicate with oral sodium bicarbonate prior to each instillation (refer to Dosing for details). Mitomycin (ureteral gel) may discolor urine to a violet to blue color following instillation. Patients should avoid contact with urine for at least 6 hours post-instillation, void urine sitting on a toilet, and flush the toilet several times after use.
Note: Mitomycin (ureteral gel) is not for intravesicular use, refer to the Mitomycin (systemic) monograph for information on off-label intravesicular use of mitomycin for injection.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Urothelial cancer, low-grade upper tract : Treatment of low-grade upper tract urothelial cancer in adults.
MitoMYcin (Ureteral gel) may be confused with MitoMYcin (Ophthalmic), MitoMYcin (Systemic), mitotane, mitoXANTRONE.
MitoMYcin is available as mitoMYcin (ureteral gel), mitoMYcin for injection, and mitoMycin (ophthalmic); the products are different and are NOT interchangeable. Verify product label prior to reconstitution and administration to prevent medication errors.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
BCG (Intravesical): Myelosuppressive Agents may decrease therapeutic effects of BCG (Intravesical). Myelosuppressive Agents may increase adverse/toxic effects of BCG (Intravesical). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Evaluate pregnancy status prior to use in females of reproductive potential. Females of reproductive potential should use effective contraception during therapy and for 6 months after the last mitomycin (ureteral gel) dose.
Males with female partners of reproductive potential should use effective contraception during therapy and for 3 months after the last dose of mitomycin (ureteral gel).
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to mitomycin (ureteral gel) may cause fetal harm.
It is not known if mitomycin (ureteral gel) is present in breast milk following administration.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 1 week after the last mitomycin (ureteral gel) dose.
Monitor blood counts (WBC count with differential, platelet count, hemoglobin) prior to each instillation; serum creatinine. Evaluate pregnancy status prior to use in females of reproductive potential. Monitor for signs/symptoms of ureteric obstruction (eg, flank pain, fever, changes in renal function).
Mitomycin alkylates DNA to produce DNA cross-linking (primarily with guanine and cytosine pairs) and inhibits DNA and RNA synthesis. Mitomycin is not cell cycle specific but has its maximum effect against cells in late G and early S phases (Perry 2012). Following instillation into the pyelocalyceal system, mitomycin (ureteral gel) forms a semisolid gel that dissolves from normal kidney urine flow, releasing mitomycin.
Absorption: Following a 60 mg instillation into the pyelocalyceal system, the mean Cmax mitomycin plasma concentration was estimated to be <1% of the expected Cmax following IV administration.
Excretion: Urine (primarily); following instillation into the pyelocalyceal system, mitomycin (ureteral gel) forms a semisolid gel that dissolves from normal kidney urine flow (releasing mitomycin) for up to 4 to 6 hours; mitomycin is eliminated unchanged in the urine. ~10% of systemically absorbed mitomycin is excreted unchanged in the urine.
