nogapendekin alfa inbakicept-pmln (Anktiva)

Indications: - for use with BCG for the treatment of aduls with BCG-unresponsive nonmuscle invasive bladder cancer Contraindications: - pregnancy - major birth defects 2-4% - miscarriage 15-20% - lactation: - no data on presence of Anktiva in human milk - estimated risk is low Dosage: - for intravesicular dosing - induction: 400 ug intravesicular with BCG once a week for 6 weeks - maintenance: 400 ug intravesicular with BCG once a week for 3 weeks at months 4, 7, 10, 13 & 19 - if complete response at >= 25 month 25 months, additional maintenance doses with BCG once a week for 3 weeks at months 25, 31, & 37 (optional) * instill intravesically only after dilution * total time from vial to instillation completion should be < 2 hours Adverse effects: - >= 15% - increased serum creatinine, increased serum potassium - dysuria, hematuria, urinary frequency, urinary urgency, urinary tract infection - musculoskeletal pain, chills, pyrexia Mechanism of action: - IL-15 receptor agonist

References

) Highlights of Prescribing Information nogapendekin alfa inbakicept-pmln (Anktiva) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf