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Nogapendekin Alfa Inbakicept

Published: July 26, 2026Updated: July 26, 2026

Nogapendekin alfa inbakicept-pmln is an IL-15 receptor agonist classified as an immunostimulant. It works by activating the IL-15 signaling pathway, which plays a crucial role in immune system regulation and the proliferation of natural killer (NK) cells and T lymphocytes. This medication is being investigated for use in cancer immunotherapy, where it aims to enhance the body's immune response against tumor cells.

Quick summary

An IL-15 receptor agonist immunostimulant being developed for cancer immunotherapy that activates and expands immune cells.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
L03AC03
RxNorm
2682678
Generic
Nogapendekin Alfa Inbakicept
Class
atc-l03
Brands
Anktiva
Availability
rx
Lactation
unknown
Routes
—
Forms
solution
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)intravesical solution
Usual dose
400 mcg once weekly
Maximum
consult physician
Frequency
weekly for 12 weeks induction, then maintenance
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (not_established)intravesical solution
Usual dose
not established
Maximum
consult physician
Frequency
not applicable
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)intravesical solution
Usual dose
400 mcg once weekly
Maximum
consult physician
Frequency
weekly for 12 weeks induction, then maintenance
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Dose exceeding recommended maximum may lead to severe immune-mediated toxicity
Chronic overdose: Cumulative dosing above recommended regimen may result in sustained immune activation
Immediate actions
Discontinue drug administration, supportive care, monitor vital signs, intravenous fluids
Antidote
No specific antidote available(Supportive care is primary management; no targeted antidote)
Poison Control: 1-800-222-1222

Special Populations

12 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits significantly outweigh risks

Monitor

regular fetal monitoring and ultrasound assessments

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

use only if benefits outweigh risks

Key Recommendations

use only when clearly needed with careful risk-benefit assessment

Monitor

routine prenatal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

use only if benefits outweigh risks

Key Recommendations

use only when clearly needed, consider timing of administration

Monitor

fetal monitoring and assessment of labor

Use with caution and monitor for adverse effects.

?

lactation

n a
unknown
FDA Category
N
Dose Adjustment

avoid or discontinue breastfeeding

Key Recommendations

discontinue breastfeeding during treatment and for at least 30 days after last dose

Monitor

monitor infant for signs of immune system effects

⚠

geriatric

n a
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required but monitor closely

Key Recommendations

use with caution due to potential age-related decline in immune function

Monitor

monitor renal function and overall treatment response

Use with caution and monitor for adverse effects.

✗

pediatric_age

children under 18
contraindicated
FDA Category
N
Dose Adjustment

not applicable

Key Recommendations

not approved for use in pediatric patients

Monitor

n_a

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

mild
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution, monitor renal function

Monitor

baseline and periodic renal function monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

moderate
caution
FDA Category
N
Dose Adjustment

consider dose adjustment based on clinical response

Key Recommendations

use with caution, more frequent monitoring recommended

Monitor

regular monitoring of renal function and treatment response

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

consider dose reduction and extended dosing intervals

Key Recommendations

use with caution in severe impairment, individualize therapy

Monitor

frequent renal function monitoring and adverse event assessment

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution, monitor hepatic function

Monitor

baseline and periodic liver function tests

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate
caution
FDA Category
N
Dose Adjustment

consider dose adjustment based on clinical response

Key Recommendations

use with caution, monitor liver function tests more frequently

Monitor

regular hepatic function monitoring

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with significant dose reduction

Key Recommendations

use with extreme caution in severe hepatic impairment

Monitor

frequent hepatic function monitoring and adverse event assessment

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2024

Drug class

Value:IL-15 receptor agonist

Immunotherapy agent classification

prescribingFDA
2024

FDA approval year

Value:2024

FDA approval date for Anktiva

usageFDA
2024

Indication

Value:Non-muscle invasive bladder cancer (NMIBC)

Therapeutic indication for Anktiva with BCG

mechanismFDA
2024

Mechanism of action

Value:IL-15 receptor agonist

Immunomodulatory mechanism

Investigational use in cancer immunotherapy, particularly being studied for the treatment of certain malignancies where immune stimulation may provide therapeutic benefit.

As an IL-15 receptor agonist, this medication binds to and activates the IL-15 receptor complex (composed of the common gamma chain, beta chain, and IL-15 receptor alpha subunit), triggering intracellular signaling that promotes the activation, proliferation, and survival of NK cells and T lymphocytes, thereby enhancing immune responses against cancer cells.

As an immunostimulant, it may cause immune-related adverse effects. Patients should be monitored for cytokine release syndrome and other immune-mediated reactions. Clinical monitoring and appropriate management of immune-related toxicities is essential during treatment.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy