Tebentafusp
Tebentafusp is a bispecific T-cell engager immunotherapy designed to treat uveal melanoma, a rare and aggressive cancer of the eye that can spread to other parts of the body. It works by redirecting the body's own T-cells to recognize and destroy melanoma cells that express the gp100 protein, offering a targeted approach for patients with this difficult-to-treat condition.
Tebentafusp is an immunotherapy for unresectable or metastatic uveal melanoma that activates T-cells to target and kill cancer cells.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XX75
- RxNorm
- 2590743
- Generic
- Tebentafusp
- Class
- atc-l01
- Brands
- Kimmtrak
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- 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
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; tebentafusp may cause harm to the developing fetus based on its mechanism of action as a bispecific T-cell engager
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
discontinue therapy if pregnancy occurs; consider risks versus benefits carefully
fetal growth monitoring and regular obstetric assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near delivery; consider timing of last dose
fetal monitoring and assessment for preterm labor
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot established
avoid breastfeeding during treatment and for at least 4 months after last dose; tebentafusp is a protein molecule that may be excreted in breast milk
no specific monitoring requirements established
pediatric_age
children adolescentsnot established
safety and efficacy not established in patients under 18 years of age; use only in clinical trials if appropriate
no established pediatric dosing or monitoring guidelines
geriatric
elderly 65 and olderno specific dose adjustment required
use with caution; no overall differences in efficacy observed but elderly patients may have increased susceptibility to immune-mediated adverse events
monitor for signs of cytokine release syndrome and immune-related adverse events
Use with caution and monitor for adverse effects.
renal_impairment
mild renal impairmentno dose adjustment required
no dose adjustment needed for mild renal impairment (CrCl 60-89 mL/min); tebentafusp is a protein therapeutic not renally excreted
routine renal function monitoring
renal_impairment
moderate severe renal impairmentuse with caution
limited data in moderate to severe renal impairment; use with caution and monitor closely
increased monitoring of renal function and adverse events
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno specific dose adjustment established
use with caution in mild hepatic impairment; limited clinical data available
monitor liver function tests and for signs of hepatotoxicity
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severe hepatic impairmentuse with caution
use with caution in moderate to severe hepatic impairment; limited data available; consider risks versus benefits
frequent monitoring of liver function tests and clinical status
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Immunotherapy drug class classification
FDA approval year
FDA approval date for Tebentafusp (Kimmtrak)
Indication
FDA-approved therapeutic indication
First-line therapy status
First therapy approved for this rare cancer type
Tebentafusp is indicated for the treatment of unresectable or metastatic uveal melanoma in HLA-A*02:01 positive adult patients, a rare form of eye cancer that has limited treatment options when it spreads.
As a bispecific T-cell receptor-CD3 engager, tebentafusp binds simultaneously to the gp100 peptide-HLA-A*02:01 complex on melanoma tumor cells and to the CD3 receptor on T-cells, forming a bridge that activates T-cells to recognize and destroy the cancer cells.
HLA-A*02:01 testing is required prior to treatment initiation. Cytokine release syndrome (CRS) is common and typically occurs early in treatment. Patients should be monitored closely during and after infusion. Other common adverse reactions include rash, pyrexia, and pruritus.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
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