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Mitomycin for pyelocalyceal instillation (ureteral gel): Drug information

Mitomycin for pyelocalyceal instillation (ureteral gel): Drug information
(For additional information see "Mitomycin for pyelocalyceal instillation (ureteral gel): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Jelmyto
Pharmacologic Category
  • Antineoplastic Agent, Antibiotic
Dosing: Adult

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

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.

Dosing: Kidney Impairment: Adult

GFR ≥30 mL/minute: There are no dosing adjustments provided in the manufacturer's labeling.

GFR <30 mL/minute: Avoid use.

Dosing: Hepatic Impairment: Adult

There are no dosing adjustments provided in the manufacturer's labeling.

Dosing: Adjustment for Toxicity: Adult

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.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Pruritus (13%)

Endocrine & metabolic: Hyperkalemia (13%), hypernatremia (11%), hyperuricemia (16%), hypoalbuminemia (28%), hypocalcemia (16%)

Gastrointestinal: Abdominal pain (28%), nausea (25%), vomiting (20%)

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 (27%), flank pain (41%)

Renal: Decreased estimated GFR (eGFR) (38%), hydronephrosis (18%), increased serum creatinine (34%), renal insufficiency (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%)

Frequency not defined: Hematologic & oncologic: Bone marrow depression

Contraindications

Perforation of the bladder or upper urinary tract.

Warnings/Precautions

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.

Dosage Forms: US

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)]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Jelmyto Ureteral)

80 (2 x 40) mg (per each): $28,404.00

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.

Administration: Adult

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 Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 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 2016; USP-NF 2020).

Use: Labeled Indications

Urothelial cancer, low-grade upper tract : Treatment of low-grade upper tract urothelial cancer in adults.

Medication Safety Issues
Sound-alike/look-alike issues:

MitoMYcin (Ureteral gel) may be confused with MitoMYcin (Ophthalmic), MitoMYcin (Systemic), mitotane, mitoXANTRONE.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

Other safety concerns:

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.

Metabolism/Transport Effects

None known.

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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

Reproductive Considerations

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).

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to mitomycin (ureteral gel) may cause fetal harm.

Breastfeeding Considerations

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.

Monitoring Parameters

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).

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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.

  1. <800> Hazardous Drugs–Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Jelmyto (mitomycin) [prescribing information]. Princeton, NJ: UroGen Pharma Inc; September 2022.
  3. Perry MC, ed. Chemotherapeutic agents: mitomycin. The Chemotherapy Source Book. 5th ed. Philadelphia, PA: 2012.
  4. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed May 5, 2020.
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