Tebentafusp-Tebn: uses, dosing, side effects & brands
Tebentafusp-Tebn is a medicine sold in the U.S. under one brand, for uveal melanoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Uveal Melanoma
- Available as
- Injectable
- Sold as
- Kimmtrak
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How tebentafusp-tebn is dosed
From the FDA label for Kimmtrak (application BLA761228). Other tebentafusp-tebn products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage: 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter ( 2.2 ). Dilute and administer by intravenous infusion over 15-20 minutes ( 2.2 , 2.4 ). See Full Prescribing Information for instructions on preparation and administration of the diluted solution for intravenous infusion ( 2.2 , 2.4 ). Dosage interruption or permanent discontinuation may be required based on individual safety and tolerability ( 2.3 ). 2.1 Patient Selection Select patients for treatment of unresectable or metastatic uveal melanoma with KIMMTRAK based on a positive HLA-A*02:01 genotyping test of a whole blood sample [see Clinical Studies (14) ] . Information on FDA-approved tests is available at http://www.fda.gov/companiondiagnostics . 2.2 Recommended Dosage The recommended dosage of KIMMTRAK administered intravenously is: 20 mcg on Day 1 30 mcg on Day 8 68 mcg on Day 15 68 mcg once every week thereafter Treat patients until unacceptable toxicity or disease progression occur. Administer the first three infusions of KIMMTRAK in an appropriate healthcare setting by intravenous infusion over 15-20 minutes. Monitor patients during the infusion and for at least 16 hours after the infusion is complete. If the patient does not experience Grade 2 or worse hypotension (requiring medical intervention)…
Tebentafusp-Tebn side effects
The following serious adverse reactions are discussed in greater detail in other sections of the label: Cytokine Release Syndrome [ see Boxed Warning , Warnings and Precautions (5.1) ] Skin Reactions [ see Warnings and Precautions (5.2) ] Elevated Liver Enzymes [ see Warnings and Precautions (5.3) ] The most common adverse reactions (occurring in ≥ 30%) are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting ( 6.1 ). The most common laboratory abnormalities (occurring in ≥50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased aspartate aminotransferase, increased alanine aminotransferase, decreased hemoglobin, and decreased phosphate ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Immunocore at 1-844-IMMUNO1 (1-844-466-8661) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. First line metastatic uveal melanoma The safety of KIMMTRAK was evaluated in study IMCgp100-202, a randomized (2:1), open-label, active-controlled trial in patients who had not…
Who shouldn’t take tebentafusp-tebn
None. None ( 4 ).
Every tebentafusp-tebn product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Kimmtrak.
Tebentafusp-Tebn recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
What people report to the FDA about tebentafusp-tebn
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4 reports naming tebentafusp-tebn, and the FDA flagged 50% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- cytokine release syndrome4 reports
- chills1 reports
- confusional state1 reports
- erythema1 reports
- hypotension1 reports
- lactic acidosis1 reports
- livedo reticularis1 reports
- muscle swelling1 reports
Read these as a signal, not a rate. A report does not mean tebentafusp-tebn caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is tebentafusp-tebn?
Kimmtrak (Tebentafusp-Tebn) is a medication used to treat Uveal Melanoma.
Can you take tebentafusp-tebn with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tebentafusp-tebn against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does tebentafusp-tebn come in?
Across the brands we track, tebentafusp-tebn is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tebentafusp-tebn?
We do not currently list a generic-labelled tebentafusp-tebn product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has tebentafusp-tebn been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions tebentafusp-tebn. The most recent: KIMMTRAK (tebentafusp-tebn) Injection (Jun 10, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tebentafusp-Tebn: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tebentafusp-tebn
- MLA
- “Tebentafusp-Tebn: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tebentafusp-tebn.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tebentafusp-tebn on DailyMed (NIH) ↗ — including its boxed warning in full.