Gemcitabine Bladder Instillation Syringe

 

Gemcitabine Bladder Instillation

 

Edge Pharma offers compounded Gemcitabine Bladder Instillation Syringe kits that include a 1g / 50mL pre-filled unit-dose syringe of Gemcitabine, 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 Gemcitabine. 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.

 

Gemcitabine Bladder Instillation Kit

Gemcitabine intravesical solution, sterile, preservative free.

Available Dosage = 1 g
Syringe Volume = 50 mL
Closed system transfer device (CSTD) and catheter tip included with kit.

 

Literature Review

 

Hemorrhagic Cystitis and Alum

“Severe hemorrhagic cystitis often arises from anticancer chemotherapy or radiotherapy for pelvic malignancies. Infectious etiologies are less common causes except in immunocompromised hosts. These cases can be challenging problems for the urologist and a source of substantial morbidity and sometimes mortality for the patients.”(1)

Hemorrhagic cystitis is defined as diffuse bladder mucosal bleeding. When caused by radiation, hemorrhagic cystitis can appear as late as two decades after treatment. Patients with hemorrhagic cystitis generally present with the following symptoms: hematuria, anemia, urinary frequency, dysuria and incontinence secondary to blood clots obstructing the urethra. “As for all treatment pathways, beginning treatment with minimally invasive therapies is always recommended. As long as the patient is hemodynamically stable, clot removal and urinary drainage are the basis for initial treatment.”(2)

“Most of the time hematuria is controlled by continuous irrigation with 0.9 percent normal saline.  This method may fail many a time and one may need to resort to transurethral fulguration of bleeding points. However, in selected cases there is a simple and safe method of continuous irrigation of the bladder with 1 percent alum solution without anesthesia, which may prevent the need for fulguration of the bleeding points or delay it for some time. Reports of toxicity due to systemic absorption of aluminum following alum irrigation are rare.”(3)

A study conducted at the Department of Urology, Mayo Clinic, identified 40 patients with hemorrhagic cystitis treated with intravesical alum. “All patients had failed continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation.” The study found the alum use decreased patients’ transfusion requirement. Without alum, 82 percent of patients required a transfusion within 30 days, and with alum instillation, 59 percent of patients required a transfusion.  The study concluded: “Intravesical alum therapy is well-tolerated, with resolution of hemorrhagic cystitis in approximately 60 percent of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with hemorrhagic cystitis.”(4) 


(1) Manikandan, R., Kumar, Santosh, Dorairajan, Lalgudi N., Indian Journal of Urologoy, online article, Hemorrhagic Cystitis: A Challenge to the Urologist,https://www.ncbi.nlm.nih.gov/
(2) Alesawa, Anwar M., El-Hakim, Assaad, Zorn, Kevin C., Saad, Fred, Current Opinion in Supportive and Palliative Care, online article, Radiation-Induced Hemorrhagic Cystitis, https://journals.lww.com/
(3) Barua, Sasanka Kumar, Das, Nabajeet, Barua, S.J. Rajeev, T.P. Bagchi, Pushal Kumar, Sarma, Debanga, Phukan, Mandeep, International Journal of Advances in Medicine, article, Management of Late Hemorrhagic Radiation in Patients of Carcinoma Cervix with Special Reference to 1 percent Alum Irrigation and Its Safety: A Clinical Study in a Tertiary Care Centre, International Journal of Advances in Medicine Barua SK et al. Int J Adv Med. 2019 Jun;6(3):599-604 http://www.ijmedicine.com 
(4) Westerman, Mary E., Boorjiam, Stephen A., Linder, Brian J., Department of Urology, Mayo Clinic, Safety and Efficacy of Intravesical Alum for Intractable Hemorrhagic Cystitis: A Contemporary Evaluation https://www.ncbi.nlm.nih.gov/pmc/

 

References

1. Mary E. Westerman, Stephen A. Boorjian, Brian J. Linder. Department of Urology, Mayo Clinic, Rochester, Minnesota, USA. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: a contemporary evaluation. (2016);42(6):1144 1149. https://www.ncbi.nlm.nih.gov/

"Intravesical alum therapy is well-tolerated, with resolution of HC in approximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC."

2. The management of intractable haematuria. S.K.S. CHOONG, M. WALKDEN and R. K IRBY, St. George's Hospital, Blackshaw Road, London, UK. BJU International (2000), 86, 951±959 http://urology.iupui.edu/

"There are various treatment options for intractable haematuria arising from several conditions applicable when more conservative measures have failed and before major surgery is contemplated or deemed unsuitable. The decision to use a particular treatment depends on the fitness of the patient and the anaesthetic requirement, the severity of the haematuria, the treatments available, the risks and severity of complications, and the prognosis of the condition. Intravesical formalin is effective in controlling intractable haematuria, but because it has potential serious complications it should be used with great caution and only after more conservative measures have failed."

"In contrast, intravesical 1% alum irrigation for intractable haematuria can be used with no spinal or general anaesthesia or elaborate radiological procedures, is generally safe,effective and well tolerated, and is suitable as a first-line treatment." 

3. Hemorrhagic cystitis in cancer patients.  Oct 07, 2019 Brian J Linder, MD, Nelson J Chao, MD, Mrinal M Gounder, MD. http://uptodate.com

"Alum — Given the efficacy and tolerable side effect profile of intravesical alum instillation, it is commonly the first intravesical therapy utilized when other more conservative measures have failed."

 

Call (802-992-1178) or email us () to learn more about this great new product and to have it added to your online ordering account. We are now taking preorders! 

 

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