Tebentafusp injection
Tebentafusp injection (Kimmtrak) is a targeted cancer therapy used to treat unresectable or metastatic uveal melanoma in adults with a specific genetic marker (HLA-A*02:01).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Tebentafusp (Kimmtrak), brand-only since about 2022, is a specialist IV drug for adults with uveal melanoma (a rare eye cancer) that has spread or cannot be removed, but only if they carry the HLA-A*02:01 immune marker. One end grabs the gp100 protein on tumor cells and the other grabs your immune T cells, which then attack the cancer. The first infusions are rough for most people, with fever, chills, rash and itching common on treatment days, and these tend to ease after the first few doses. The thing to watch is cytokine release syndrome (CRS), a boxed-warning immune overreaction that can turn life-threatening, so the first three infusions each need at least 16 hours of monitoring.
Clinical pearls
- Plan for an overnight stay, since each of the first three infusions needs at least 16 hours of monitoring.
- Expect regular liver blood tests, and report yellow skin or eyes or dark urine, since liver enzyme rises are common.
- Bring a full medication list, because the cytokine surge can slow the liver enzymes that break down other drugs.
- Use effective birth control during treatment and for one week after the last dose, and do not breastfeed during that time.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Kimmtrak carries a serious boxed warning about cytokine release syndrome (CRS) — a potentially life-threatening immune reaction. CRS occurred in patients receiving Kimmtrak and can range from mild (fever, chills) to severe (dangerously low blood pressure, difficulty breathing). Because of this risk, you must be monitored in a healthcare setting for at least 16 hours after each of your first three infusions. After that, monitoring requirements are based on how you tolerate the medication. Signs of CRS include fever, low blood pressure, low blood oxygen, nausea, vomiting, rash, and extreme fatigue — seek medical attention immediately if these occur.
Patient information guide A plain-language walkthrough of Tebentafusp injection, written from its FDA label.
What Tebentafusp injection is used for
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Tebentafusp (Kimmtrak) is approved for one specific cancer indication at the ingredient level:
- Kimmtrak is indicated for the treatment of adults with unresectable or metastatic uveal melanoma — a form of eye cancer that cannot be surgically removed or has spread to other parts of the body — who test positive for the HLA-A*02:01 genetic marker on a blood test
How Tebentafusp injection works
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Kimmtrak is what's called a bispecific T cell engager — a molecule with two distinct targeting arms. One arm recognizes a protein called gp100, which is displayed on the surface of uveal melanoma tumor cells in people who carry the HLA-A*02:01 immune marker. The other arm latches onto T cells, which are your immune system's natural cancer-fighting cells. By physically connecting T cells to tumor cells, Kimmtrak activates those T cells to release toxic proteins that destroy the cancer cells directly.
After dosing, immune signaling proteins called cytokines spike in the blood — especially with the first three doses — which is why side effects like fever and low blood pressure are common early on. These cytokine levels tend to return to baseline before each next dose, and the reactions are usually less intense with later doses.
Tebentafusp injection dosage
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Kimmtrak is given as an intravenous (IV) infusion — not as a pill or self-injection. The dose is stepped up gradually over the first two weeks to help your body adjust, then given once every week after that. Each infusion runs for about 15–20 minutes. There are no food restrictions tied to dosing, but your care team may have preparation instructions.
- First three infusions require monitoring in a healthcare facility for at least 16 hours after each infusion
- Later infusions may be given in an outpatient (ambulatory) setting with shorter monitoring, if the earlier infusions were well tolerated
- Treatment continues until the cancer progresses or side effects become unacceptable — follow your oncology team's schedule exactly
Dosing details from the FDA-approved label
From the Tebentafusp injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Unresectable or metastatic uveal melanoma (HLA-A*02:01 positive patients)
- 20 mcg intravenously on Day 1, 30 mcg on Day 8, 68 mcg on Day 15, and 68 mcg once every week thereafter
- Administered by intravenous infusion over 15-20 minutes
- Treat patients until unacceptable toxicity or disease progression occur
- Administer the first three infusions in an appropriate healthcare setting and monitor for at least 16 hours after the infusion; no dosage reduction is recommended.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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) during or after the third infusion, administer subsequent doses in an appropriate ambulatory care setting, and monitor patients for a minimum of 30 minutes following each of these infusions [see Warnings and Precautions (5.1) ] . 2.3 Dosage Modifications for Adverse Reactions No dosage reduction for KIMMTRAK is recommended. Dosage modifications for KIMMTRAK for adverse reactions are summarized in Table 1 . Table 1: Dose Modifications for Adverse Reactions a Based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (NCI CTCAEv4.03).
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Tebentafusp injection side effects
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Most people treated with Kimmtrak experience side effects, especially early in treatment. The most common ones include:
Common side effects
- Cytokine release syndrome (immune reaction causing fever, chills, low blood pressure)
- Rash or skin redness
- Itching (pruritus)
- Fever (pyrexia)
- Fatigue
- Nausea or vomiting
- Swelling (edema)
- Headache
- Cytokine release syndrome (CRS) — fever, chills, low blood pressure, low oxygen
- Abdominal pain
- Dry skin
When to get medical help
- Get emergency help immediately if you have high fever, severe low blood pressure, difficulty breathing, or feel very unwell during or after your infusion — these may be signs of cytokine release syndrome (CRS), which can be life-threatening
- Call your doctor right away if you develop a severe skin rash, widespread redness, or significant skin swelling
- Tell your doctor if you notice yellowing of the skin or eyes, dark urine, or severe tiredness — these may signal liver enzyme problems
- If you are pregnant or become pregnant during treatment, tell your doctor immediately — this drug may harm an unborn baby
Serious reactions — including severe CRS, significant skin reactions, or major liver enzyme elevations — require immediate medical attention. Call your care team right away or go to the emergency room if you experience high fever, difficulty breathing, severe rash, or signs of liver problems such as yellowing of the skin or eyes.
Tebentafusp injection warnings and precautions
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- Cytokine release syndrome (CRS): The biggest risk with Kimmtrak. It happened in the large majority of patients in trials and can be life-threatening. Symptoms include fever, low blood pressure, low blood oxygen, chills, nausea, and fatigue. The first three infusions require at least 16 hours of monitored observation afterward. Treatment may need to be paused, and corticosteroids (anti-inflammatory drugs) may be given to manage CRS.
- Skin reactions: Rash, itching, redness, and swelling of the skin occurred in most patients. These usually begin the day of infusion. Mild cases are managed with antihistamines or topical steroids; severe cases may require IV steroids or stopping treatment.
- Elevated liver enzymes: Most patients experienced some rise in liver enzymes, especially during the first three doses. Your care team will monitor your liver function with regular blood tests. Severe elevations may require holding or stopping treatment.
- Fetal harm: Kimmtrak may harm an unborn baby. Effective contraception is required during treatment and for 1 week after the last dose. Pregnancy should be ruled out before starting treatment.
Tebentafusp injection interactions
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Kimmtrak has a limited but important drug interaction profile based on how it affects the body:
- Drugs processed by CYP450 liver enzymes: The surge of inflammatory cytokines triggered by Kimmtrak can suppress these enzymes, which are responsible for breaking down many common medications. This could cause other drugs in your system to build up or behave differently — tell your oncologist and pharmacist about everything you take.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tebentafusp injection
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- HLA-A*02:01 testing required: You must have a confirmed positive result from an FDA-approved blood test for this marker before starting Kimmtrak — it will not work otherwise
- Pregnancy: Kimmtrak may harm a fetus. A pregnancy test is required before starting. Use effective contraception during treatment and for 1 week after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for at least 1 week after the last dose — the drug may pass into breast milk and harm a nursing infant
- Children: Safety and effectiveness have not been established in pediatric patients
- Older adults (65+): Included in clinical trials — no significant differences in safety or effectiveness were observed compared to younger adults
- Kidney impairment: Mild to moderate kidney disease did not meaningfully affect how Kimmtrak works in the body; severe kidney impairment has not been studied
- Liver impairment: Mild liver impairment did not significantly affect drug levels; moderate to severe liver impairment has not been studied — discuss with your doctor if this applies to you
What Tebentafusp injection does in the body
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After each of the first three Kimmtrak doses, immune signaling proteins called cytokines — including IFN-γ, TNFα, IL-2, and IL-6 — spike in the blood, typically peaking 8 to 24 hours after the infusion and returning to baseline before the next dose. White blood cell counts (lymphocytes) also dip the day after those early doses and recover before the next treatment. With later doses, these immune reactions tend to be less intense and occur in fewer patients, suggesting the body partially adapts to the treatment over time.
How your body processes Tebentafusp injection
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Kimmtrak is given directly into the bloodstream by IV infusion, so absorption is immediate. It distributes into a relatively small volume in the body and has a short half-life of about 7.5 hours — meaning it clears fairly quickly. The drug is broken down into small peptides and amino acids (the building blocks of proteins) rather than processed by the liver in the traditional way. Weight, sex, age, and mild-to-moderate kidney or mild liver impairment do not significantly affect how the drug behaves in the body. The drug does not accumulate with weekly dosing.
How to store Tebentafusp injection
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Store KIMMTRAK vials in the original carton refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Tebentafusp injection
50 supplements and herbal products have documented interactions with Tebentafusp injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 9
- Moderate · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Tebentafusp injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Tebentafusp injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Kimmtrak and why do I have to get a genetic test before starting it?
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I keep hearing about 'cytokine release syndrome.' What does that actually feel like and when should I go to the hospital?
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Will the side effects get better over time, or will every infusion be this rough?
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Why do I need to have my liver checked regularly while on this drug?
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Is it safe to take my other medications while on Kimmtrak?
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Can I get pregnant or breastfeed while on Kimmtrak?
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Is Tebentafusp injection available over the counter?
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When was Tebentafusp injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tebentafusp injection on HelloPharmacist
Tebentafusp injection forms and strengths (how it comes)
Tebentafusp injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tebentafusp injection inactive ingredients by manufacturer.
Injection
How this form is used
- Kimmtrak is used intravenously to treat HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma who have not received prior systemic therapy
- Kimmtrak is administered by intravenous infusion over 15–20 minutes in a healthcare setting
- Kimmtrak requires a two-step dilution process before infusion — preparation must be done using aseptic technique by trained healthcare staff
- For the first three infusions, Kimmtrak must be given in an appropriate healthcare facility with monitoring during the infusion and for at least 16 hours afterward
- Kimmtrak must not be mixed with other medications or infused through the same IV line as other drugs
Tebentafusp injection on the U.S. market: products, makers and brands
How Tebentafusp injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Tebentafusp injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2022. Brand names on the directory include Kimmtrak; the rest are generics.
How widely Tebentafusp injection is used (Medicaid data)
A general measure of how commonly Tebentafusp injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tebentafusp injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tebentafusp injection prescribed? Of the 1,601 medications we measure, Tebentafusp injection ranks #1,448 by Medicaid prescriptions — more than 10% of them.
Utilization by Tebentafusp injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
0.5 ML tebentafusp-tebn 0.2 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2590748
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tebentafusp injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Tebentafusp injection NDCs with Medicaid activity.
Compare Tebentafusp injection products
A representative set of FDA-listed product records for Tebentafusp injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 100 mcg/0.5 mL | Intravenous | Immunocore Commercial LLC | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Tebentafusp injection NDCs →
Tebentafusp injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tebentafusp injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tebentafusp injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Tebentafusp injection FDA approval history
How Tebentafusp injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Tebentafusp injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Tebentafusp recalls since July 2021.
✅No Tebentafusp recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2590743 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2590747In current FDA listingsClinical drug / strength (SCD) 0.5 ML tebentafusp-tebn 0.2 MG/MLRxCUI 2590748
Look up RxCUI 2590743 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Tebentafusp injection supply and shortage status
Whether Tebentafusp injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Tebentafusp injection brand names
Tebentafusp injection is sold under one brand name in the FDA directory — Kimmtrak. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tebentafusp injection: manufacturers and labelers
One company lists Tebentafusp injection products with the FDA. By number of product records, the largest are Immunocore Commercial LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Tebentafusp injection drug class (RxNorm)
Tebentafusp injection belongs to the Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Tebentafusp injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Immunocore Commercial LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →