What Should Nurses Know: Gemcitabine Intravesical System’s Approval

Patients should receive regular urinalyses and urine cultures while being treated with gemcitabine intravesical system.

With the approval of gemcitabine intravesical system (Inlexzo) for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) on September 9, it’s essential that nurses have familiarity with the device’s safety signals as well as how to monitor them. In an interview with Oncology Nursing News, Gary Steinberg, MD, a bladder cancer specialist at Rush Medical Group in Chicago, Illinois, outlined consideration for nurses using the newly approved treatment.

The treatment is administered at 225 mg via catheter inserted every 3 weeks for as long as 6 months (8 doses), then once every 12 weeks for as long as 18 months (6 doses).¹

According to data from cohort 2 of the single-arm, multicenter phase 2b SunRISe-1 trial (NCT04640623) published in the Journal of Urology, most patients (83.5%) experienced treatment-related adverse effects (TRAEs). Most were low-grade lower urinary tract AEs, with 11 patients (12.9%) experiencing grade 3 or higher TRAEs.² Five patients (5.9%) had serious TRAEs, and 3 (3.5%) discontinued treatment due to unacceptable toxicity.

Steinberg mentioned that monitoring for AEs with the pretzel-shaped device must include regular urinalyses and urine cultures. He added that overactive bladder medication may not be the right fit for managing patients on gemcitabine intravesical system.

Additionally, Steinberg noted that patients may need to acidify or alkalize their urine, depending on their individual needs.

Oncology Nursing News: What monitoring should patients continue to have with gemcitabine intravesical system?

Steinberg: Patients are going to have symptoms with various treatments. They’re going to have a significant number of complaints with TAR-200 [gemcitabine intravesical system]. It’s going to be important that patients get urinalyses and urine cultures. It’s important that that they avoid constipation or anything that may exacerbate their lower urinary tract symptoms.

There will be attempts at using overactive bladder medication, but there are AEs, and I’ve never been convinced how effective they are, especially in an elderly patient with a foreign body being instrumented in their bladder continuously for 6 months.

What should nurses educate patients to do to avoid AEs while undergoing treatment with gemcitabine intravesical system?

You want patients to be hydrated and potentially even try to acidify their urine to decrease some of their symptoms and so forth, or alkalize their urine, depending [on the patient]. It’s going to be individualized patient to patient depending on their symptoms. I suspect there will be phone calls, as well as a learning curve for the office to learn how to manage some of the adverse effects.

What resources or other education should nurses give to patients?

There is a 10-page handout that describes the process of putting in the “pretzel” (the TAR-200 device) and taking it out again. It’s important for nurses to think about how when this patient calls, it’s not your routine patient calling with urinary symptoms, but it’s your patient that also has this foreign [object in their system]. Nurses have to keep that in the back of their mind and recognize that their typical advice and treatments may not necessarily work as well because of this foreign body.

This transcript has been edited for clarity and conciseness.

References

1. FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer. FDA. September 9, 2025. Accessed September 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer
2. Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. J Urol. 2025;213(5S2):e2. doi:10.1097/01.JU.0001111604.90306.91.03