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