Active Ingredient: Nogapendekin alfa
Nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
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.
For induction: nogapendekin alfa inbakicept is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3.
For maintenance: After BCG and nogapendekin alfa inbakicept induction therapy, nogapendekin alfa inbakicept is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses). For patients with an ongoing complete response at month 25 and later, maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations.
The recommended duration of treatment is until disease persistence after second induction, disease recurrence or progression, unacceptable toxicity, or a maximum of 37 months.
For intravesical use only. Do NOT administer by subcutaneous or intravenous or intramuscular routes.
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