The Complete Solution For Mitomycin Bladder Instillation

 

Edge Pharma offers compounded Mitomycin bladder instillation syringe kits that include a 40mg/40mL pre-filled unit-dose syringe of Mitomycin, a closed system transfer device (CSTD), and catheter tip. The CSTD is attached by Edge in an ISO 5 environment according to CGMP. This solution solves the USP 800 hazardous compounding challenge many hospitals and clinics now face when trying to administer Mitomycin. Since the product comes ready-to-administer, you do not need to compound a hazardous drug in your facility. Edge specializes in offering hazardous compounding services for organizations, making the transition to USP 800 compliance easier.

See Also:
Mitomycin Ophthalmic Solution syringes

 

Mitomycin C Bladder Instillation Kit


Mitomycin C sterile intravesical solution, preservative free. Closed system transfer device (CSTD) and catheter tip included with kit.

Available Dosage = 40 mg*
Syringe Volume = 40 mL

*Custom dosages available upon request 

 

Since it is in final dosage form, the kit does not need to be separated during storage from other medications, according to USP 800 standards. Please see below: 

From USP 800 Hazardous Drugs – Handling in Health Care Settings 5.2

"Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Nonantineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy."

 

Mitomycin C Bladder Instillation Kit Pending Pending

 

Literature Review

 

Intravesical chemotherapy is commonly administered after transurethral resection of the bladder (TURBT). Generally, the bladder instillation is done within a day of the TURBT procedure, with the goal of killing any cancer cells that may be left in the bladder.(1)

Mitomycin-C is the most frequently used chemotherapy agent administered intravesically. Other agents used to treat bladder carcinoma include:

  • Gemcitabine
  • Doxorubicin
  • Valrubicin
  • Thiotepa
  • Cisplatin
  • Nano-particle albumin-bound paclitaxel(2)

Intravesical therapy is used to treat non-invasive (Stage 0) and minimally invasive (Stage 1) cancers. In these cases, one treatment may be used. Intermediate cancers may be treated with induction therapy, followed by maintenance treatments.(1) Bacillus Calmette-Guerin (BCG) intravesical immunotherapy is also used to treat early stage bladder cancer.(3)

The American Urological Association reports that studies show the use of Mitomycin-C reduces the rate of recurrence of cancer by 10-15 percent.(4)
Bladder cancer is the sixth most common cancer in the U.S., according to the American Cancer Society, which estimates that 81,400 new cases of bladder cancer will be seen in the U.S. in 2020.(5)



(1) American Cancer Society, Intravesical Therapy for Bladder Cancer, https://www.cancer.org/
(2) Brosman, S. MD, Schwartz, D. MO, Medscape, Treatment of Bladder Carcinoma In Situ, https://www.cancer.org/
(3) National Institute of Health, National Cancer Institute, Bladder Cancer Treatment, https://www.cancer.gov
(4) American Urological Association, Non-muscle Invasive Bladder Cancer: Intravesical Therapy, https://www.urologyhealth.org/
(5) American Cancer Society, Key Statistics for Bladder Cancer, https://www.cancer.org

 


References

Mian, Badar. "Immediate Post-TURBT Mitomycin Instillation Reduces Recurrence Risk." Urology Times, Vol. 45 Issue 12, Nov. 2017: p. 9.

"Mitomycin C (MMC) instillation within 24 hours after transurethral resection (TURBT) of non-muscle invasive bladder cancer (NMIBC) significantly reduces the risk of recurrence and delays the time to recurrence."

"The recurrence risk in the entire cohort was significantly lower at 27% in the immediate instillation group compared to 36% in the delayed instillation group (p<.001)."

 

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