UpToDate خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده:
4
September 2025
Dosage guidance:
Safety: Administer by intravesical instillation only; do not administer by pyelocalyceal instillation or by any other route. Do not administer mitomycin (intravesical gel) if mucosal integrity of bladder has been compromised or bladder perforation is present; delay treatment until restoration of bladder integrity.
Dosage forms information: Do NOT substitute mitoMYcin (intravesical gel) with or for other mitoMYcin products or formulations. MitoMYcin is available in various formulations: mitoMYcin for injection, mitoMYcin (intravesical gel), mitoMYcin (ureteral gel), and mitoMYcin (ophthalmic); the products are different and are NOT interchangeable. Refer to the MitoMYcin (systemic) monograph for off-label intravesical use of mitomycin injection for bladder instillation.
Bladder cancer, non–muscle invasive, recurrent, low grade, intermediate risk:
Intravesical instillation: 75 mg instilled once weekly into the bladder (via a urinary catheter) for 6 weeks (Ref).
eGFR 60 to <90 mL/minute: No dosage adjustment necessary.
eGFR 30 to <60 mL/minute: No dosage adjustment necessary; a higher incidence of hematuria and urinary tract infections has been observed with eGFR 30 to <60 mL/minute; monitor for increased adverse reactions.
eGFR <30 mL/minute: Avoid use.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Increased serum potassium (26%)
Genitourinary: Dysuria (23%), urinary tract infection (12%)
Hematologic & oncologic: Decreased hemoglobin (17%; grades 3/4: <1%), eosinophilia (15%), lymphocytopenia (14%; grades 3/4: <1%)
Hepatic: Increased serum alanine aminotransferase (15%), increased serum aspartate aminotransferase (15%)
Renal: Increased serum creatinine (29%)
1% to 10%:
Genitourinary: Balanoposthitis (<10%), genital edema (<10%), genital pain (<10%), genital pruritus (<10%), genital rash (<10%), hematuria (10%), nocturia (<10%), urethral stricture (<10%), urethritis (<10%), urinary frequency (<10%), urinary incontinence (<10%), urinary retention (<10%), urinary urgency (<10%)
Hematologic & oncologic: Decreased neutrophils (10%; grades 3/4: <1%)
Nervous system: Fatigue (<10%)
Renal: Acute kidney injury (<10%)
Hypersensitivity to mitomycin or any component of the formulation; perforation of the bladder.
Disease-related concerns:
• Perforated bladder: Mitomycin (intravesical gel) may lead to systemic mitomycin exposure and severe adverse reactions if administered to patients with a perforated bladder or in patients with compromised bladder mucosal integrity.
Other warnings/precautions:
• Product selection: Mitomycin is available as mitomycin (intravesical gel), 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.
Zusduri intravesical solution: FDA approved June 2025; availability anticipated on or around July 1, 2025.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravesical [preservative free]:
Zusduri: Mitomycin 2 x 40 mg (1 ea) [contains polyethylene glycol (macrogol)]
No
Mitomycin (intravesical gel) is available through specialty distributors; information from the manufacturer may be found at: https://www.zusduri.com/hcp/pdf/urogen-account-set-up-form.pdf.
Intravesical instillation: Administer via intravesical instillation only. Do not administer via pyelocaliceal installation or by any other route. When ready to instill, place dispensed vial in a plastic bag and seal, and place plastic bag in an ice bath for ~20 minutes, ensuring the vial is completely immersed in the ice bath, allowing for mitomycin (intravesical gel) conversion to a viscous liquid. Remove vial from ice bath and verify admixture has liquified (if not liquified, place back in bag in the ice bath). Gently swirl the upright vial to uniformly mix; do not invert or shake the vial. Refer to manufacturer's detailed instructions on how to withdraw final administration product (4 administration 20 mL syringes with 14 mL each [total dose volume: 56 mL]); place capped, filled syringes back into the plastic bag in the ice bath and completely immerse for at least 2 minutes; keep each filled syringe in the ice bath until instillation. Using a 12 to 16 French urinary catheter with a fixed Luer lock connector, drain bladder and instill contents of each syringe over ~30 seconds in rapid succession (without delay to avoid solidification); after all 4 syringes have been instilled, flush urinary catheter with 3 mL sterile water. Once inside the bladder, mitomycin (intravesical gel) will convert to a semisolid gel for prolonged exposure. Wait 15 minutes before removing the urinary catheter from the patient.
Advise patients to avoid skin contact with the urine, to void sitting on a toilet, to wash hands and genital area with soap and water after each urination, and to flush toilet several times after use for at least 24 hours after instillation. Any clothing soiled with urine should be promptly washed separately from other clothing. Patients should be aware that mitomycin (intravesical gel) is a violet to blue color and may discolor urine following instillation.
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 (Ref).
Bladder cancer, non–muscle invasive, recurrent, low grade, intermediate risk: Treatment of recurrent, low-grade, intermediate-risk, non–muscle invasive bladder cancer (LG-IR-NMIBC) in adults.
MitoMYcin (Intravesical Gel) may be confused with MitoMYcin (Ureteral Gel), MitoMYcin (Ophthalmic), MitoMYcin (Systemic), mitotane, mitoXANTRONE.
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.
MitoMYcin is available as mitoMYcin for injection, mitoMYcin (intravesical gel), mitoMYcin (ureteral gel), 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.
There are no known significant interactions.
Verify pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 6 months after the last mitomycin (intravesical gel) dose.
Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last mitomycin (intravesical gel) dose.
Based on the mechanism of action and data from animal reproduction studies, mitomycin (intravesical gel) may cause fetal harm.
It is not known if mitomycin (intravesical gel) is present in human milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment or for 1 week after the final mitomycin (intravesical gel) dose.
Verify pregnancy status prior to treatment initiation (in patients who could become pregnant). Evaluate bladder mucosal integrity prior to intravesical instillation. Monitor for increased adverse reactions in patients with moderate kidney impairment.
Mitomycin inhibits DNA synthesis; the guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations, cellular RNA and protein synthesis are also suppressed. Mitomycin (intravesical gel) is a reverse thermal hydrogel formulation, which is a viscous liquid when chilled and solidifies at body temperature, creating a semisolid gel in the bladder for prolonged exposure; the gel slowly disintegrates for up to 6 hours, allowing prolonged exposure at tumor sites and adjacent areas (Ref).
Absorption: Following a 75 mg instillation into the bladder, the mean Cmax of mitomycin (intravesical gel) measured hourly for up to 6 hours following bladder instillation is <1% of the expected Cmax following IV administration.
Metabolism: Primarily hepatic, although metabolism may also occur in other tissues.
Excretion: Urine (primarily); following instillation into the bladder, mitomycin (intravesical gel) forms a semisolid gel that dissolves in the urine. Visible gel was reported in the urine for a median of 5 hours (range: up to 24 hours) after instillation; mitomycin is eliminated unchanged in the urine. Approximately 10% of systemically absorbed mitomycin is excreted unchanged in the urine.
Molecular weight: 334.33.
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