Active Ingredient: Nogapendekin alfa
Nogapendekin alfa in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravesical, 400 micrograms nogapendekin alfa, once weekly, 6 doses in total, over the duration of 3 months. Afterwards, intravesical, 400 micrograms nogapendekin alfa, once weekly, 3 doses in total, over the duration of 3 months. Afterwards, intravesical, 400 micrograms nogapendekin alfa, once weekly, 3 doses in total, over the duration of 3 months. Afterwards, intravesical, 400 micrograms nogapendekin alfa, once weekly, 3 doses in total, over the duration of 3 months. Afterwards, intravesical, 400 micrograms nogapendekin alfa, once weekly, 3 doses in total, over the duration of 6 months. Afterwards, intravesical, 400 micrograms nogapendekin alfa, once weekly, 3 doses in total, over the duration of 6 months. Afterwards, in case that there is very good treatment response, intravesical, 400 micrograms nogapendekin alfa, once weekly, 3 doses in total, over the duration of 6 months. This step is repeated 3 times.
Nogapendekin alfa is recommended at a dose of 400 micrograms; administered intravesically as a mixture with BCG recommended at a dose of 50 mL once a week for 6 weeks. A second induction course (re-induction) may be administered in case of residual CIS +/- High grade Ta at the first assessment after induction (at week 12).
After BCG and nogapendekin alfa induction therapy, for patients with lack of disease or low-grade Ta, continued treatment is recommended at a dose of 400 micrograms administered intravesically with BCG once a week for 3 consecutive weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses).
Presence of a low-grade Ta will require a transurethral resection of bladder tumour (TURBT) procedure prior to instillation. Treatment may be delayed by up to 28 days after TURBT procedure if required. For patients with an ongoing complete response as defined by negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology at month 25 and later, maintenance instillations with nogapendekin alfa and BCG may be administered once a week for 3 consecutive weeks at months 25, 31, and 37 for a maximum of 9 additional instillations. Assessment of tumour status should be performed every 3 months for up to 24 months. Assessment for ongoing response beyond month 24 is per local community standards.
The recommended duration of treatment is until disease persistence after the last induction cycle (initial, or if administered, second induction) disease recurrence or progression (new CIS and/or any T1 disease or greater), unacceptable toxicity, or a maximum treatment duration of 37 months.
Nogapendekin alfa is administered intravesically with BCG into the bladder via a catheter. Connect a catheter to the suspension container directly or using a 50-mL syringe connected to an appropriate size needle/connecter, withdraw the 50 mL nogapendekin alfa with BCG mixture and attach to a urinary catheter. Instil the mixture through the urinary catheter and into the bladder.
After instillation is complete, the catheter is removed. The nogapendekin alfa in combination with BCG admixture is retained in the bladder for 2 hours and then voided. Patients unable to retain the suspension for 2 hours should be allowed to void sooner, if necessary. The dose should not be repeated if the patient voids before 2 hours.
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