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Anktiva (nogapendekin alfa inbakicept-pmln)
nogapendekin alfa inbakicept intravesical
Adult Dosing .
Dosage forms: SOLUTION
Special Note
- [drug name clarification]
- Info: nonproprietary name = nogapendekin alfa inbakicept-pmln
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing
non-muscle invasive bladder CA in situ, BCG-unresponsive
- [induction tx]
- Dose: 400 mcg intravesically qwk x6wk; Info: for patients with or without papillary tumors; use with BCG; may repeat induction tx x1 if complete response not achieved at month 3
- [maintenance tx, patients in complete response after 1st induction tx]
- Dose: 400 mcg intravesically qwk x3wk at months 4, 7, 10, 13, and 19; Info: for patients with or without papillary tumors; use with BCG; if continued complete response, may give additional 400 mcg intravesically qwk x3wk at months 25, 31, and 37 for max tx duration of 37mo
- [maintenance tx, patients in complete response after 2nd induction tx]
- Dose: 400 mcg intravesically qwk x3wk at months 7, 10, 13, and 19; Info: for patients with or without papillary tumors; use with BCG; if continued complete response, may give additional 400 mcg intravesically qwk x3wk at months 25, 31, and 37 for max tx duration of 37mo
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: patients of childbearing potential
Drug Interactions .
Overview
nogapendekin alfa inbakicept intravesical
IL-15 agonist intravesical
- immunomodulatory effects
Monitor/Modify Tx
- avian influenza vaccine
- COVID-19 vaccine
- ebola vaccine, live
Adverse Reactions .
Serious Reactions
- hematuria
Common Reactions
- dysuria
- hematuria
- urinary frequency
- urinary urgency
- UTI
- musculoskeletal pain
- rigors
- fever
- fatigue
- bladder irritation
- diarrhea
- nocturia
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though risk of fetal harm not expected based on minimal systemic absorption; possible risk of fetal harm based on drug's mechanism of action if systemic absorption occurs
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x1wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for nogapendekin alfa inbakicept: other; CYP450: unknown
Excretion: for nogapendekin alfa inbakicept: unknown; Half-life: unknown
Subclass: Immunotherapy, Interleukin-15
Mechanism of Action
for nogapendekin alfa inbakicept: binds and activates IL-15 receptors, resulting in proliferation and activation of NK, CD8+, and memory T cells
Formulary .
No Formulary Selected
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