Home › NDC Lookup › Ingredients › Tebentafusp › 80446-0401-01
💉image loading
(from DailyMed)

KIMMTRAK TEBENTAFUSP 100 ug/.5mL Injection, Solution, Concentrate, 1 vial — NDC 80446-401-01 (Billing 80446-0401-01)

by Immunocore Commercial LLC · 1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS

This is a package of 1 vial of KIMMTRAK TEBENTAFUSP 100 ug/.5mL Injection, Solution, Concentrate from Immunocore Commercial LLC, marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 80446-0401-01
🏷️ FDA NDC (as labeled) 80446-401-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 80446-401-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
80446 labeler · 401 product · 01 package
Package marketed since
Jan 26, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0380446401013
Medicaid fills, this package
170 prescriptions in the last four reported quarters
FDA record last changed
Sep 3, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80446-401-01
Product NDC 80446-401
11-digit billing NDC 80446040101
NCPDP billing unit ML — per mL (volume)
RxCUI 2590748, 2590754
UNII N658GY6L3E
UPC 0380446401013
Application # BLA761228
SPL Set ID 24a49f57-d2fc-4ffe-9eb1-fe0460c6b067
Established class (EPC) Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager
Mechanism of action Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions; CD3-directed Antibody Interactions; CD3 Receptor Agonists
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance TEBENTAFUSP
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 083006
GCN 49664
HICL code 047779
Ingredient (HICL) Tebentafusp-Tebn
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V17
Therapeutic class — specific (HIC3) Antineoplastic - Immunotherapy, T-Cell Engager
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name KIMMTRAK 100 MCG/0.5 ML VIAL
FDB brand name Kimmtrak
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083006
  • GCN: 49664
  • HICL (First Databank): 047779
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2590748
Why two NDCs? The FDA registers this code as 80446-401-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 80446-0401-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager class.

Pharmacologic class Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager
Drug family (ATC) Other antineoplastic agents
How it works CD3-directed Antibody Interactions, CD3 Receptor Agonists, Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name KIMMTRAK 100 MCG/0.5 ML VIAL Ingredient Tebentafusp-Tebn
📗 Our plain-language guide HelloPharmacist
  • Kimmtrak is a targeted cancer treatment that works by connecting your own immune cells to the tumor cells to destroy them. The thing is, it can only do that job if your tumor cells...
  • What exactly is Kimmtrak and why do I have to get a genetic test before starting it?
  • Cytokine release syndrome — CRS — is an immune overreaction that happens because Kimmtrak activates your immune system in a big way. It usually feels like a sudden, intense flu: fe...
  • I keep hearing about 'cytokine release syndrome.' What does that actually feel like and when should I go to the hospital?
📖 Read our full Tebentafusp injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $43,860.76 $21,930.38 / 0.5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9274 $228.006 / J9274 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)80446-401-01
11-digit billing NDC80446-0401-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9274
DescriptorInjection, tebentafusp-tebn, 1 microgram
Billing units / pkg100 units
How the units are derivedThis package is 0.5; the HCPCS unit is 1 MCG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$24,057,545 · 997 claims · $24,129.93 per claim (all NDCs under J9274)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80446-0401-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS 2022-01-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kimmtrak 100 ug/.5mLthis 80446-0401-01 Immunocore 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2022
First FDA approval
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2034. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 25, 2022 ⏳ ~7.3 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Kimmtraktebentafusp-tebn
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2022 2024 2026 2028 2030 2032 2034
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJan 25, 2034
Common questions
Is there a biosimilar for KIMMTRAK 100 MCG/0.5 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Tebentafusp injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerImmunocore Commercial LLC
FDA applicationBLA761228 (BLA)
Labeler code80446
First marketedJan 2022
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 87 words ▾

BOXED WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK.

Monitor for at least 16 hours following first three infusions and then as clinically indicated ( 2.2 , 5.1 ).

🎯 Indications and Usage 49 words ▾

1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).

⏱️ Dosage and Administration ~3 min read ▾

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 ).

2.1Patient 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 .

2.2Recommended 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) ] .

2.3Dosage 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).

Adverse Reaction Severity KIMMTRAK Dosage Modifications Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1) ] Moderate defined as temperature ≥ 38°C with Hypotension that responds to fluids (does not require vasopressors) or Hypoxia requiring low flow nasal canula (≤ 6 L/min) or blow-by oxygen If hypotension and hypoxia do not improve within 3 hours or CRS worsens, escalate care and manage according to next higher level of severity For moderate CRS that is persistent (lasting 2-3 hours) or recurrent, administer corticosteroid premedication (e.g. dexamethasone 4 mg or equivalent) at least 30 minutes prior to next dose Severe defined as temperature ≥ 38°C with Hemodynamic instability requiring a vasopressor (with or without vasopressin) or Worsening hypoxia or respiratory distress requiring high flow nasal canula (> 6 L/min oxygen) or face mask Withhold KIMMTRAK until CRS and sequelae have resolved Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent) Resume KIMMTRAK at same dose level (i.e., do not escalate if severe CRS occurred during initial dose escalation; resume escalation once dosage is tolerated) For severe CRS, administer corticosteroid premedication (e.g. dexamethasone 4 mg or equivalent) at least 30 minutes prior to next dose Life threatening defined as temperature ≥ 38°C with Hemodynamic instability requiring multiple vasopressors (excluding vasopressin) Worsening hypoxia or respiratory distress despite oxygen administration requiring positive pressure Permanently discontinue KIMMTRAK Administer intravenous corticosteroid (e.g., 2 mg/kg/day methylprednisolone or equivalent) Skin Reactions [see Warnings and Precautions (5.2) ] Grade 2 or 3 a Withhold KIMMTRAK until ≤ Grade 1 or baseline Resume KIMMTRAK at same dose level (i.e., do not escalate if Grade 3 skin reactions occurred during initial dose escalation; resume escalation once dosage is tolerated) For persistent reactions not responding to oral… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 31 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 mcg/0.5 mL clear, colorless to slightly yellowish solution in a single-dose vial Injection: 100 mcg/0.5 mL solution in a single-dose vial ( 3 ).

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Skin reactions : Rash, pruritus, and cutaneous edema occurred in patients treated with KIMMTRAK. If skin reactions occur, treat based on persistence and severity of symptoms ( 2.3 , 5.2 ). Elevated liver enzymes : Elevations in liver enzymes occurred in patients treated with KIMMTRAK.

Monitor ALT, AST, and total bilirubin ( 2.3 , 5.3 ). Embryo-Fetal toxicity : May cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.4 , 8.1 , 8.3 ).

5.1Cytokine Release Syndrome Cytokine release syndrome (CRS), which may be life threatening, occurred in patients receiving KIMMTRAK. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS (≥ Grade 2) occurred in 77% of patients in Study IMCgp100-202 who received KIMMTRAK [see Adverse Reactions (6.1) ] .

Among patients who received KIMMTRAK, 23% received systemic corticosteroids for at least 1 infusion, 8% received supplemental oxygen during at least 1 infusion, and 0.8% received a vasopressor for at least 1 infusion. CRS led to permanent discontinuation in 1.2% of patients. In Study IMCgp100-202, 60% of patients experienced ≥ Grade 2 CRS with more than 1 infusion, with the median number of events being 2 (range 1 - 12).

The majority (84%) of episodes of CRS started the day of infusion. Among cases that resolved, the median time to resolution of CRS was 2 days. Ensure that healthcare providers administering KIMMTRAK have immediate access to medications and resuscitative equipment to manage CRS.

Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK [see Dosage and Administration (2.2) ] . Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy.

Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS [see Dosage and Administration (2.3) ] .

5.2Skin Reactions Skin reactions, including rash, pruritus, and cutaneous edema occurred in patients treated with KIMMTRAK. In study IMCgp100-202, skin reactions occurred in 91% of patients treated with KIMMTRAK, including Grade 2 (44%) and Grade 3 (21%) events. Skin reactions included rash (83%), pruritus (69%), erythema (25%), and cutaneous edema (27%) [see Adverse Reactions (6.1) ] .

The median time to onset of skin reactions was 1 day (range: 1 – 55 days). The median time to improvement to ≤ Grade 1 was approximately 6 days. Monitor patients for skin reactions.

If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions [see Dosage and Administration (2.3) ] .

5.3Elevated Liver Enzymes In Study IMCgp100-202, increases in alanine aminotransferase or aspartate aminotransferase were observed in 65% of patients treated with KIMMTRAK. In patients experiencing ALT/AST elevations, 73% initially occurred within the first 3 infusions with KIMMTRAK. Most patients experiencing Grade 3 or 4 ALT/AST elevations had improvement to ≤ Grade 1 within 7 days.

For events that were observed outside the setting of CRS, the median time to onset was 129 days. Grade 3 or greater elevations in liver enzymes outside the setting of CRS occurred in approximately 8% of patients. Elevations in liver enzymes led to permanent discontinuation in 0.4% of patients receiving KIMMTRAK.

Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity [see Dosage and Administration (2.3) ] .

5.4Embryo-Fetal Toxicity Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to t… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 .

6.1Clinical 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 received prior systemic therapy for metastatic or advanced uveal melanoma [see Clinical Studies (14) ] .

Patients received either KIMMTRAK administered at 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 (N=245) or investigator’s choice treatment (N=111). The median duration of exposure was 5.3 months (range: 0.3 to 33 months) in patients treated with KIMMTRAK. Serious adverse reactions occurred in 28% of patients who received KIMMTRAK.

Serious adverse reactions occurring in ≥ 2% of patients were cytokine release syndrome (10%), rashes (4.5%), pyrexia (2.4%), and hypotension (2%). One patient (0.4%) experienced a fatal adverse reaction (pulmonary embolism). Adverse reactions led to permanent discontinuation in 3.3% of patients who received KIMMTRAK.

Adverse reactions that led to permanent discontinuation of KIMMTRAK were anaphylactic reaction, brain edema, cytokine release syndrome, fatigue, hepatotoxicity, hypotension, and nausea (each 0.4%). Adverse reactions resulting in dosage interruption occurred in 25% of patients who received KIMMTRAK. Adverse reactions which required dosage interruption in ≥ 2% of patients included fatigue (3.7%), lipase increased (2.9%), pyrexia (2.4%), alanine aminotransferase increase (2%), and aspartate aminotransferase increase (2%).

Adverse reactions leading to dose reduction occurred in 5% of patients who received KIMMTRAK. Adverse reactions which required dosage reduction in ≥ 2% of patients were cytokine release syndrome (2.4%), and rashes (2%). The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting.

The most common (≥50%) laboratory abnormalities in patient who received KIMMTRAK were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate. Table 4 summarizes the adverse reactions observed in study IMCgp100-202. Table 4: Adverse Reactions (≥20%) in Patients with Metastatic Uveal Melanoma Who Received KIMMTRAK in Study IMCgp100-202 a Represents algorithmic identification of CRS cases based on ASTCT grading criteria (Lee et al.

2019). b Represents a composite of multiple related terms. Adverse Reactions KIMMTRAK (N=245) Investigator’s Choice (pembrolizumab, or ipilimumab, or dacarbazine) (N=111) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (% )… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK.

Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of tebentafusp-tebn in human milk, the effect on the breastfed child, or the effects on milk production. Because tebentafusp-tebn may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with KIMMTRAK and for at least 1 week after the last dose.

8.3Females and Males of Reproductive Potential KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating KIMMTRAK treatment. Contraception Females Advise female of reproductive potential to use effective contraception during treatment and for 1 week following the last dose of KIMMTRAK [see Use in Specific Populations (8.1) ] .

8.4Pediatric Use Safety and efficacy of KIMMTRAK have not been established in pediatric patients.

8.5Geriatric Use Of the 245 patients with metastatic uveal melanoma treated with KIMMTRAK on IMCgp100-202, 47% were 65 years of age and older and 9% were 75 years of age and older. No overall differences in safety or efficacy were observed between patients ≥ 65 years of age compared to younger adult patients.

🤰 Pregnancy 95 words ▾

8.1Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK.

Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and efficacy of KIMMTRAK have not been established in pediatric patients.

🧓 Geriatric Use 54 words ▾

8.5Geriatric Use Of the 245 patients with metastatic uveal melanoma treated with KIMMTRAK on IMCgp100-202, 47% were 65 years of age and older and 9% were 75 years of age and older. No overall differences in safety or efficacy were observed between patients ≥ 65 years of age compared to younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells. In vitro, tebentafusp-tebn bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumor cells.

12.2Pharmacodynamics Lymphocyte counts declined the day after the first 3 doses and returned to baseline prior to subsequent doses. Serum levels of cytokines (IFN-γ, TNFα, IL-2, IL-6, IL-10 and IL-1RA) and chemokines (CXCL9, CXCL10, CXCL11, hepatocyte growth factor, and monocyte chemoattractant protein-1) were increased during the first three doses of KIMMTRAK with peak levels between 8 to 24 hours after treatment with KIMMTRAK and levels returned to baseline prior to subsequent doses. In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the first 3 doses.

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of KIMMTRAK have not been fully characterized.

12.3Pharmacokinetics After a single dose administration, tebentafusp-tebn C max and AUC 0-7d increased in an approximately dose proportional manner from 20 to 68 mcg (0.3 to 1 times the approved recommended dose). Following administration of the approved recommended dosage in patients with metastatic uveal melanoma, the steady-state geometric mean (% CV) C max of tebentafusp-tebn is 13 ng/mL (34.6%) and AUC 0-7d is 4.6 ng.day/mL (23%) with no accumulation. Distribution Tebentafusp-tebn geometric mean (% CV) steady-state volume of distribution is

7.56L (24%). Elimination The geometric mean clearance of tebentafusp-tebn is

16.4L/d (CV: 24.5%) and median terminal half-life is 7.5 hours (range: 6.8-7.5 hours). Metabolism Tebentafusp-tebn is expected to be catabolized into small peptides and amino acids. Specific Populations No clinically significant difference in the pharmacokinetics of tebentafusp-tebn were identified based on weight (43 to 163 kg), sex (48% female), age (23 to 91 years), or mild to moderate renal impairment based on creatinine clearance (CL cr ) estimated by C-G formula (CL cr 30 to 89 mL/min) or mild hepatic impairment as measured by total bilirubin (TB) and aspartate aminotransferase (AST) (TB ≤ upper limit of normal (ULN) and AST > ULN or TB > 1 to 1.5x ULN and any AST).

Tebentafusp-tebn has not been studied in patients with severe (CL cr < 30 mL/min) renal impairment or in patients with moderate (TB >1.5 to 3x ULN, any AST) to severe (TB > 3 to 10x ULN, any AST) hepatic impairment. Drug Interaction Elevation of certain proinflammatory cytokines may suppress CYP450 enzyme activities.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other products or studies, including those of KIMMTRAK. In studies IMCgp100-102 and IMCgp100-202, 36% (47/131) and 28% (67/240) of patients who were treated with tebentafusp-tebn at the recommended dosing regimen for up to 29 cycles and 45 cycles, respectively, developed anti-tebentafusp-tebn antibodies (ADA).

Among the patients who developed ADAs, neutralizing antibodies (NAb) against tebentafusp-tebn were detected in 57% (27/47) and 63% (42/67), respectively, in studies IMCgp100-102 and IMCgp100-202. The median onset time to ADA formation was 8 and 12 weeks and 15 and 16 weeks for NAb formation after tebentafusp-tebn treatment in studies IMCgp100-102 and IMCgp100-202, respectively. Tebentafusp-tebn exposure was lower in the pres… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 72 words ▾

12.1Mechanism of Action Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells. In vitro, tebentafusp-tebn bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumor cells.

📦 How Supplied / Storage and Handling 77 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Each KIMMTRAK (tebentafusp-tebn) injection carton (NDC 80446-401-01) contains: One single-dose vial containing 100 mcg of tebentafusp-tebn in 0.5 mL of sterile, preservative-free, clear, colorless or slightly yellowish solution. The vial stopper is not made with natural rubber latex. Storage and Handling 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. Do not shake.

📋 Description 95 words ▾

11 DESCRIPTION Tebentafusp-tebn is a bispecific gp100 peptide-HLA-directed T cell receptor CD3 T cell engager. Tebentafusp-tebn has an approximate molecular weight of 77 kDa. Tebentafusp-tebn is produced by recombinant DNA technology in Escherichia coli cells.

KIMMTRAK (tebentafusp-tebn) injection is supplied in a single-dose vial as a sterile, preservative-free, clear, colorless or slightly yellowish solution for intravenous administration by infusion. Each single-dose vial contains tebentafusp-tebn (100 mcg), citric acid monohydrate (0.95 mg), di-sodium hydrogen phosphate (2.91 mg), mannitol (5 mg), polysorbate 20 (0.1 mg) trehalose (25 mg), and water for injection, with a pH of 6.5.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Cytokine Release Syndrome (CRS) Inform patients of the risk of CRS, and to immediately contact their healthcare provider for signs and symptoms associated with CRS (e.g., pyrexia, hypotension, hypoxia, chills, nausea, vomiting, fatigue, or headache) [see Warnings and Precautions (5.1) ] . Skin Reactions Inform patients that rashes and skin reactions have occurred in patients who have received KIMMTRAK.

Advise patients to contact their healthcare provider for signs and symptoms of progressive or intolerable skin reactions [see Warnings and Precautions (5.2) ] . Elevated Liver Enzymes Inform patients that elevations in liver enzymes have occurred in patients who have received KIMMTRAK. Advise patients to contact their healthcare provider for signs and symptoms of liver toxicity (e.g., right sided abdominal pain, jaundice, scleral icterus) [see Warnings and Precautions (5.3) ] .

Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform females of the risk to a fetus [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception while on KIMMTRAK and for 1 week after the last dose [see Use in Specific Populations (8.1) and (8.3) ] .

Lactation Advise patients not to breastfeed during treatment with KIMMTRAK and for 1 week after the last dose [see Use in Specific Populations (8.2) ] . Manufactured by: Immunocore Limited 92 Park Drive, Milton Park Abingdon, Oxfordshire United Kingdom, OX144RY License no: 2239 At: Simtra Deutschland GmbH Kantstraβe 2 33790 Halle/Westfalen Germany For: Immunocore Commercial LLC 100 Matsonford Road, 1 Radnor Corporate Center Suite 100 Radnor, PA US

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics After a single dose administration, tebentafusp-tebn C max and AUC 0-7d increased in an approximately dose proportional manner from 20 to 68 mcg (0.3 to 1 times the approved recommended dose). Following administration of the approved recommended dosage in patients with metastatic uveal melanoma, the steady-state geometric mean (% CV) C max of tebentafusp-tebn is 13 ng/mL (34.6%) and AUC 0-7d is 4.6 ng.day/mL (23%) with no accumulation. Distribution Tebentafusp-tebn geometric mean (% CV) steady-state volume of distribution is

7.56L (24%). Elimination The geometric mean clearance of tebentafusp-tebn is

16.4L/d (CV: 24.5%) and median terminal half-life is 7.5 hours (range: 6.8-7.5 hours). Metabolism Tebentafusp-tebn is expected to be catabolized into small peptides and amino acids. Specific Populations No clinically significant difference in the pharmacokinetics of tebentafusp-tebn were identified based on weight (43 to 163 kg), sex (48% female), age (23 to 91 years), or mild to moderate renal impairment based on creatinine clearance (CL cr ) estimated by C-G formula (CL cr 30 to 89 mL/min) or mild hepatic impairment as measured by total bilirubin (TB) and aspartate aminotransferase (AST) (TB ≤ upper limit of normal (ULN) and AST > ULN or TB > 1 to 1.5x ULN and any AST).

Tebentafusp-tebn has not been studied in patients with severe (CL cr < 30 mL/min) renal impairment or in patients with moderate (TB >1.5 to 3x ULN, any AST) to severe (TB > 3 to 10x ULN, any AST) hepatic impairment. Drug Interaction Elevation of certain proinflammatory cytokines may suppress CYP450 enzyme activities.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Lymphocyte counts declined the day after the first 3 doses and returned to baseline prior to subsequent doses. Serum levels of cytokines (IFN-γ, TNFα, IL-2, IL-6, IL-10 and IL-1RA) and chemokines (CXCL9, CXCL10, CXCL11, hepatocyte growth factor, and monocyte chemoattractant protein-1) were increased during the first three doses of KIMMTRAK with peak levels between 8 to 24 hours after treatment with KIMMTRAK and levels returned to baseline prior to subsequent doses. In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the first 3 doses.

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of KIMMTRAK have not been fully characterized.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other products or studies, including those of KIMMTRAK. In studies IMCgp100-102 and IMCgp100-202, 36% (47/131) and 28% (67/240) of patients who were treated with tebentafusp-tebn at the recommended dosing regimen for up to 29 cycles and 45 cycles, respectively, developed anti-tebentafusp-tebn antibodies (ADA).

Among the patients who developed ADAs, neutralizing antibodies (NAb) against tebentafusp-tebn were detected in 57% (27/47) and 63% (42/67), respectively, in studies IMCgp100-102 and IMCgp100-202. The median onset time to ADA formation was 8 and 12 weeks and 15 and 16 weeks for NAb formation after tebentafusp-tebn treatment in studies IMCgp100-102 and IMCgp100-202, respectively. Tebentafusp-tebn exposure was lower in the presence of ADAs and NAbs.

In Studies IMCgp100-102 and IMCgp100-202, tebentafusp-tebn treated patients who developed ADAs had tebentafusp-tebn concentrations (C max ) that were 50% to 99% lower compared to patients who did not develop ADAs. Tebentafusp-tebn clearance was higher in patients with high titer ADAs (titers > 8192), resulting in a lower exposure (AUC 0-7 days ) by 97% compared to patients who did not develop ADA, and terminal half-life decreased to 10-14 minutes. Development of high titer Nabs (titers >100 in Study IMCgp100-102 or >640 in Study IMCgp100-202) resulted in lower C max of tebentafusp-tebn by 85% to 99% compared to patients who did not develop NAbs, and the tebentafusp-tebn concentrations (C max ) became undetectable in 43.5% (30/69) of patients who developed NAbs in both studies.

The effect of ADA and NAb on pharmacodynamics, safety, or effectiveness of tebentafusp-tebn has not been fully characterized.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Study IMCgp100-202: First line metastatic uveal melanoma KIMMTRAK was evaluated in IMCgp100-202, a randomized, open-label, multicenter trial (NCT03070392) that enrolled patients with metastatic uveal melanoma (N=378). Patients were required to be HLA-A*02:01 genotype positive identified by a central assay. Patients were excluded if they received prior systemic therapy for metastatic or advanced uveal melanoma or localized liver-directed therapy.

Prior surgical resection of oligometastatic disease was permitted. Patients with clinically significant cardiac disease or the presence of symptomatic or untreated brain metastasis were excluded. Patients were randomized (2:1) to receive KIMMTRAK weekly by intravenous infusion administered at 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 (N=252) or Investigator’s choice (N=126) of pembrolizumab, ipilimumab, or dacarbazine.

Randomization was stratified by lactate dehydrogenase (LDH) level at study entry. Across both arms, patients stopped treatment for disease progression, unless the patient was otherwise deriving benefit, or for unacceptable toxicity. The major efficacy outcome was overall survival (OS).

Additional efficacy outcomes were investigator-assessed progression free survival (PFS) and objective response rate (ORR) per RECIST 1.1. The median age was 64 years (range 23 to 92 years); 50% were female; 87% were White, and 12% were unreported or unknown race. The reported ethnicity was Hispanic or Latino in 2.4% of patients.

Baseline ECOG performance status was 0 (73%), 1 (21%), or 2 (0.3%); 36% had elevated LDH level; and 94% had liver metastasis. The efficacy results are summarized in Table 6 and Figure 1 . Table 6: Efficacy Results in Study IMCgp100-202 CI= Confidence Interval, HR= Hazard Ratio 1 Based on prespecified interim analysis 2 Hazard ratio is from a cox proportional hazards model stratified by LDH status 3 Two-sided p-value based on log rank test stratified by LDH 4 Compared to the interim efficacy boundary of 0.006 5 Final PFS analysis 6 Compared to the efficacy boundary of 0.05.

7 Not formally tested KIMMTRAK (N=252) Investigator’s Choice (pembrolizumab, or ipilimumab, or dacarbazine) (N=126) Overall Survival (OS) 1 Number of deaths 87 (34.5%) 63 (50%) Median in months (95% CI) 21.7 (18.6, 28.6) 16 (9.7, 18.4) HR (95% CI) 2 0.51 (0.37, 0.71) p-value 3, 4 <0.0001 Progression-free Survival 5 Number (%) of patients with event 198 (78.6%) 97 (77%) Median in months (95% CI) 3.3 (3, 5) 2.9 (2.8, 3) HR (95% CI) 2 0.73 (0.58, 0.94) p-value 3, 6 0.0139 Objective Response Rate (95% CI) 7 9.1% (5.9, 13.4) 4.8% (1.8, 10.1) Complete Response 1 (0.4%) 0 Partial Response 22 (8.7%) 6 (4.8%) Figure 1: Kaplan-Meier Curves of Overall Survival in Study IMCgp100-202 Figure 1

🧪 Nonclinical Toxicology 32 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with tebentafusp-tebn. No studies have been conducted to evaluate the effects of tebentafusp-tebn on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 29 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with tebentafusp-tebn. No studies have been conducted to evaluate the effects of tebentafusp-tebn on fertility.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Revised August 2026 PATIENT INFORMATION KIMMTRAK ® (KIM-track) (tebentafusp-tebn) Injection What is the most important information I should know about KIMMTRAK? KIMMTRAK can cause serious side effects that can be severe or, life threatening, and usually happens within the first three infusions.

These side effects include: Cytokine Release Syndrome (CRS). Tell your healthcare provider right away if you get any of the following symptoms: fever tiredness or weakness vomiting chills nausea low blood pressure dizziness and light headedness headache wheezing and trouble breathing rash Your healthcare provider will check for these problems during treatment with KIMMTRAK. Your healthcare provider may temporarily stop or completely stop your treatment with KIMMTRAK, if you have severe side effects.

See “ What are the possible side effects of KIMMTRAK? ” for more information about side effects. What is KIMMTRAK? KIMMTRAK is a prescription medicine used to treat HLA-A*02:01-positive adults with uveal melanoma that cannot be removed by surgery or has spread.

Your healthcare provider will test you for a presence of HLA-A*02:01 gene to make sure KIMMTRAK is right for you. It is not known if KIMMTRAK is safe and effective in children. Before you receive KIMMTRAK, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.

KIMMTRAK may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with KIMMTRAK. For females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with KIMMTRAK.

Use an effective form of birth control during treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK. are breastfeeding or plan to breastfeed. It is not known if KIMMTRAK passes into your breast milk. Do not breastfeed during the treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive KIMMTRAK? KIMMTRAK will be given to you by intravenous (IV) infusion into your vein for 15 to 20 minutes.

KIMMTRAK is usually given every week. Your healthcare provider will decide how many treatments you need. Your healthcare provider will keep you under observation for at least 16 hours following the first three KIMMTRAK treatments and for at least 30 minutes after future treatments.

Your healthcare provider may delay your treatment of KIMMTRAK if you have certain side effects. Your healthcare provider may do blood tests regularly during treatment with KIMMTRAK. What are the possible side effects of KIMMTRAK?

KIMMTRAK can cause serious side effects, including: See " What is the most important information I should know about KIMMTRAK? ”. Skin reactions . KIMMTRAK may cause skin reactions that require treatment.

Tell your healthcare provider if you get symptoms of skin reactions, such as rash, itching, or skin swelling, that are severe and do not go away. Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start KIMMTRAK and during treatment with KIMMTRAK.

Tell your healthcare provider if you get symptoms of liver problems such as right-sided abdominal pain or yellowing of the skin or eyes. The most common side effects of KIMMTRAK include: cytokine release syndrome (CRS) rash fever itching tiredness nausea chills stomach pain swelling low blood pressure (symptoms may include dizziness or light headedness) dry skin headache vomiting abnormal liver blood tests These are not all the possible side effects of KIMMTRAK. Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. General information about safe and effect… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 38 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 80446-401-01 - 100 mcg/0.5 mL Carton Label 80446-401-01 - 100 mcg/0.5 mL Carton Label

PRINCIPAL DISPLAY PANEL - NDC: 80446-401-01 - 100 mcg/0.5 mL Vial Label 80446-401-01 - 100 mcg/0.5 mL Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
170
Units reimbursed last 4 qtrs
42
Gross reimbursed last 4 qtrs
$1.84M
Avg / prescription
$10,836.19
Avg / unit
$43,503.41
Latest quarter Q1 2026
28Rx
Fee-for-service vs managed care ⓘ
54% FFS 46% MCO
Fee-for-service · 92 Rx Managed care · 78 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 6 units · 0.1 per 100k residents MI New York: 3 units · 0.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 5 units · 0.1 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 23 units · 0.7 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5 units · 0.1 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arkansas 0.7 /100k
2 Louisiana 0.1 /100k
3 Indiana 0.1 /100k
4 Michigan 0.1 /100k
5 New York 0.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for KIMMTRAK (this brand).

Top reported reactions

Cytokine Release Syndrome115
Pyrexia104
Disease Progression72
Rash68
Hypotension67
Malignant Neoplasm Progression60
Chills57

Age at onset

Adult28
Elderly6

Reporter sex

581 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization195
Life-threatening30
Disabling3
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 139 100
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Immunocore Commercial LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Immunocore Commercial LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9274 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 80436-0077-01 · RMT 80447-0649-12 · Fact →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.