KIMMTRAK (tebentafusp) 200 micrograms/ mL concentrate for solution for infusion

Patient Leaflet Updated 21-Apr-2026 | Immunocore Limited

KIMMTRAK (tebentafusp) 200 micrograms/ mL concentrate for solution for infusion

Package leaflet: Information for the patient

KIMMTRAK 200 micrograms/mL concentrate for solution for infusion

tebentafusp

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What KIMMTRAK is and what it is used for
2. What you need to know before you are given KIMMTRAK
3. How KIMMTRAK is given
4. Possible side effects
5. How KIMMTRAK is stored
6. Contents of the pack and other information

1. What KIMMTRAK is and what it is used for

KIMMTRAK contains the active substance ‘tebentafusp’. KIMMTRAK is used to treat a rare eye cancer called ‘uveal melanoma’.

Tebentafusp is an anticancer medicine, made from two different proteins that are fused together.

One of these proteins recognises and attaches to an antigen (a target protein) called ‘gp100’. Gp100 is found at high levels in uveal melanoma cancer cells. The other protein recognises and attaches to a protein called CD3. CD3 is found on certain cells of the body’s immune system. By binding to gp100 and CD3, KIMMTRAK activates your immune system to recognise and destroy the cancer cells.

KIMMTRAK is used when the uveal melanoma has grown despite local treatment, or has spread to other parts of the body.

2. What you need to know before you are given KIMMTRAK

Do not use KIMMTRAK if you are allergic to tebentafusp or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic to any of the ingredients, talk to your doctor or nurse before you are given KIMMTRAK.

Warnings and precautions

Talk to your doctor or nurse before you are given KIMMTRAK, about all of your medical conditions, particularly if you have following:

  • heart problems including a change in the electrical activity of your heart (QT interval prolongation)

Your doctor may give you a HLA genotyping blood test before treatment to determine if KIMMTRAK is suitable for you.

Tell your doctor or nurse immediately if you have any of the following during or after your treatment:

  • fever, extreme tiredness, vomiting, chills, dizziness, light headedness, shortness of breath, rapid heart rate, or coughing which may be symptoms of a condition known as ‘cytokine release syndrome’.
  • itchy skin, rash, severe hives, peeling or flaking skin, or swelling of body and/or skin around the eyes which may be symptoms of skin reactions.
  • heart problems such as rapid or irregular heart beat or a change in the electrical activity of the heart that can cause serious irregular heart rhythms which can manifest as palpitations, shortness of breath, light headedness or dizziness, or chest pain.

Your doctor or nurse will monitor you for signs and symptoms of these reactions during and after each dose. If you have any severe problems, your treatment may be temporarily stopped and started again when you feel better.

Before KIMMTRAK treatment

Tell you doctor before being given KIMMTRAK if you are taking corticosteroid medication to treat adrenal insufficiency (also known as ‘Addison’s disease’). Your doctor may need to adjust your corticosteroid dose while you are being treated with KIMMTRAK.

Children and adolescents

KIMMTRAK should not be used in children under age of 18 years. This is because there is limited information on how well it works in this age group.

Other medicines and KIMMTRAK

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

KIMMTRAK should not be used in pregnancy unless you and your doctor agree the benefit of taking this medicine outweighs any potential risks. There is no data on the use of KIMMTRAK in pregnant women. Your doctor or nurse will give you a test for pregnancy before you start treatment with KIMMTRAK. If you become pregnant during KIMMTRAK treatment, inform your doctor or nurse immediately.

Contraception

If you are female and of child-bearing age, you must use effective birth control to avoid becoming pregnant during KIMMTRAK treatment and for at least 1 week after your last dose. Discuss with your doctor the most appropriate methods of birth control.

Breastfeeding

You should not breast-feed during treatment with KIMMTRAK. It is not known if KIMMTRAK passes into your breast milk.

Driving and using machines

KIMMTRAK is unlikely to affect your ability to drive or use machines. If you feel unwell whilst being treated with this medicine you should not drive or operate machinery until you feel well again.

3. How KIMMTRAK is given

This medicine will be given to you by a healthcare professional in a hospital or clinic.

The recommended dose of KIMMTRAK is:

  • 1st dose: 20 micrograms
  • 2nd dose: 30 micrograms
  • 3rd dose: 68 micrograms
  • All further doses: 68 micrograms

You may be given fluids by infusion before each KIMMTRAK infusion to help prevent low blood pressure from cytokine release syndome (see section 2 and 4).

Your doctor or nurse will give you KIMMTRAK through an infusion (drip) into your vein (intravenous) over 15-20 minutes. You will be given KIMMTRAK once a week, for as long your doctor thinks treatment is benefitting you.

The first three doses will be given to you in hospital. You will be monitored for any side effects during treatment and for at least 16 hours after each dose.

If the first three doses do not cause any serious or unmanageable side effects, your next doses may be given in a clinic. You will be monitored for any side effects during treatment and for at least 30 minutes after each dose.

If you miss an appointment for your next KIMMTRAK dose contact your doctor or nurse as soon as possible to reschedule your appointment.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately or seek urgent medical attention if you experience any of the following very common side effects during or after treatment:

  • Fever, dizziness, light headedness. These may be symptoms of a serious condition called ‘cytokine release syndrome’. Other symptoms of cytokine release syndrome are difficulty breathing, nausea, vomiting, fatigue, muscle pain, joint pain, swelling, low blood pressure, rapid heart rate, or headache.
  • Itchy skin, rash, severe hives, peeling or flaking skin, swelling of body and/or skin around the eyes which may be symptoms of skin reactions.
  • Heart problems such as rapid or irregular heart beat or a change in the electric activity of the heart that can cause serious irregular heart rhythms which can manifest as palpitations, shortness of breath, light headedness or dizziness, or chest pain.

These symptoms mostly occur after the first three infusions.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people)

  • Decreased appetite
  • Prickling, tingling or numbness in any section of the body
  • Cough
  • Diarrhoea
  • Stomach pain
  • Chills
  • Trouble sleeping
  • Indigestion
  • Flu-like symptoms
  • Flushing
  • Elevated blood pressure
  • Constipation
  • Dry skin
  • Redness of skin
  • Changes to the colour of the skin
  • Pain in back or limbs

Very common abnormalities in blood tests that can cause side effects (may affect more than 1 in 10 people)

  • Increased levels of aspartate aminotransferase and alanine aminotransferase in the blood, which may be a sign of liver problems
  • Increased levels of bilirubin in the blood, which may be a sign of liver problems
  • Low level of phosphate in the blood
  • Increased level of digestive enzyme, lipase in the blood
  • Decreased level of white blood cells in the blood (neutropenia)
  • Decreased level of magnesium in the blood
  • Decreased level of sodium in the blood
  • Decreased level of calcium in the blood
  • Decreased level of potassium in the blood
  • Decreased hemoglobin in the blood (anaemia)

Common side effects (may affect up to 1 in 10 people)

  • Infection of nasal passages
  • Mouth pain
  • Hair loss
  • Excessive sweating during the night
  • Unusual mood changes including anxiety
  • Irregular heart beat
  • Shortness of breath
  • Spasms of the muscles

Common abnormalities in blood tests that can cause side effects (may affect up to 1 in 10 people)

  • Elevated level of digestive enzyme, amylase in the blood
  • Elevated level of creatinine in the blood, which may be a sign of kidney problems
  • Increased level of gamma glutamyltransferase and alkaline phosphatase in the blood, which may be a sign of liver problems
  • Increased level of white blood cells in the blood

Uncommon side effects (may effect up to 1 in 100 people)

  • Dying cells release large amounts of potassium, phosphate, and uric acid into the blood
  • Chest discomfort or pain as a result of coronary heart disease

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How KIMMTRAK is stored

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.

Unopened vial: Store at 4 °C to 8 °C

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not use this medicine if you notice visible signs of deterioration (i.e. particles, discolouration).

If not used immediately, the prepared infusion may be stored for up to 4 hours below 30 °C or for 24 hours at 2 °C to 8 °C from the time of preparation/dilution until the end of administration.

Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What KIMMTRAK contains
  • The active substance is tebentafusp. Each vial contains 100 micrograms of tebentafusp in 0.5 mL of concentrate.
  • The other ingredients are citric acid monohydrate, di-sodium hydrogen phosphate, mannitol, trehalose, polysorbate 20, water for injections.

What KIMMTRAK looks like and contents of the pack

KIMMTRAK concentrate for solution for infusion is a clear, colourless to slightly yellowish solution in a single-dose vial.

The pack size is 1 glass vial per carton.

Marketing Authorisation Holder
Immunocore Limited
92 Park Drive
Abingdon
Oxfordshire
OX14 4RY
United Kingdom

Manufacturer
ProPharma Group The Netherlands B.V.
Schipholweg 59
2316 ZL Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in March 2026

Detailed information on this medicine is available on the website of the Medicines and Healthcare Regulatory Agency (MHRA) https://www.gov.uk/guidance/find-product-information-about-medicines and other websites https://www.medicines.org.uk/emc/

Company Contact Details
Immunocore Limited
Address

92 Park Drive, Milton Park, Abingdon, Oxon, OX14 4RY, UK

Medical Information Direct Line

+44 (0)20 3996 7074

WWW

https://www.immunocore.com/

Telephone

+44 (0)1235 438600

Medical Information e-mail