GEMCITABINE IMPLANT

Clinical Criteria Summary

BCG-Unresponsive, non–muscle invasive bladder cancer
Formulary agents for BCG-unresponsive disease are contraindicated or not medically advisable
Not a candidate for radical cystectomy or patient prefers bladder preservation

Care is provided by a VA/VA Community Care oncology provider
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Goals of care and role of Palliative Care consult have been discussed and documented
For females who can become pregnant and males with partners who can become pregnant: Counseling on treatment risks vs benefits and use of effective contraception during and for 6 months after last treatment for women and 3 months for men

BCG unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
High-risk NMIBC (high-grade Ta, any T1)

Intravesical instillation: 225 mg once every 3 weeks for up to 8 doses (6 months)
Followed by 225 mg once every 12 weeks for up to 6 doses (18 months), or until persistent/recurrent NMIBC, disease progression, or unacceptable toxicity
Implant must be inserted into the bladder via urinary catheter and stylet; removed after 3 weeks with cystoscope

Verify pregnancy status prior to treatment initiation
Evaluate bladder mucosal integrity prior to intravesical instillation
Monitor for progression of bladder cancer
Monitor for signs/symptoms of urinary tract infection (UTI)
Patients who could become pregnant must use effective contraception during treatment and for 6 months after final gemcitabine removal from the bladder
Patients with partners who could become pregnant must use effective contraception during treatment and for 3 months after final gemcitabine removal
Breastfeeding is not recommended during treatment and for at least 1 week after gemcitabine removal from the bladder

Hypersensitivity (including anaphylaxis) to gemcitabine or any component of the formulation
Perforation of the bladder
Caution regarding delaying cystectomy in patients with BCG unresponsive CIS, as it could lead to muscle-invasive or metastatic bladder cancer
Precaution for use with MRI; gemcitabine for injection and gemcitabine intravesical are not interchangeable

Considered an option for patients desiring bladder-sparing therapy or who are unable to undergo radical cystectomy
VA clinical pathways recommend shared decision making among alternative options including pembrolizumab, gemcitabine/docetaxel, nadofaragene firadenovec, or nogapadekin alfa + BCG