Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kimmtrak

Document Subject

Generated Narrative: MedicinalProductDefinition mp1e954682407ee7d7521ef7ec82e30f79

identifier: http://ema.europa.eu/identifier/EU/1/22/1630/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: KIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1e954682407ee7d7521ef7ec82e30f79

identifier: http://ema.europa.eu/identifier/EU/1/22/1630/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kimmtrak

Attesters

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 to store KIMMTRAK
6. Contents of the pack and other information

KIMMTRAK contains the active substance tebentafusp.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 to treat adults with a rare eye cancer called uveal melanoma . The medicine is used when the uveal melanoma has grown despite local treatment, or has spread to other parts of the body.

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 blood test called HLA genotyping before treatment to determine if KIMMTRAK is suitable for you.

Tell your 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. Tell your doctor or nurse immediately or seek urgent medical attention if you have any of the following side effects during or after your 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 (itchy swellings under the skin), 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.

Children and adolescents Do not give this medicine to children under the 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. If you are a woman who can become pregnant, your doctor or nurse will give you a pregnancy test 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 (contraception) 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.

Breast-feeding 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 while being treated with this medicine you should not drive or operate machinery until you feel well again.

KIMMTRAK contains sodium This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially sodium- free .

This medicine will be given to you by a doctor or nurse in a hospital or an outpatient setting.

You may be given fluids by infusion (drip) before each KIMMTRAK infusion to help prevent low blood pressure due to 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 to 20 minutes. You will be given KIMMTRAK once a week, for as long your doctor thinks you are benefitting from the treatment.

The recommended dose of KIMMTRAK is:

• Day 1: 20 micrograms
• Day 8: 30 micrograms
• Day 15: 68 micrograms Once every week thereafter: 68 micrograms

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 an outpatient setting. You will be monitored for any side effects during treatment and for at least 60 minutes after each dose. If you have received KIMMTRAK treatment in an outpatient setting for at least 3 months without a break lasting longer than 2 weeks, then monitoring may be decreased after each dose to at least 30 minutes.

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.

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. These symptoms mostly occur after the first three infusions.
• Itchy skin, rash, severe hives(itchy swellings under the skin, peeling or flaking skin, swelling of the body and/or skin around the eyes, which may be symptoms of skin reactions.These symptoms mostly occur after the first three infusions.
• 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.

Other side effects Tell your doctor if you notice any of the following side effects:

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

• Decreased appetite
• Prickling, tingling or numbness in any part of the body
• Cough
• Diarrhoea
• Constipation
• Indigestion
• Stomach pain
• Chills
• Trouble sleeping (insomnia)
• Flu like symptoms
• Inability to sleep
• Flushing of the skin
• High blood pressure
• Dry skin
• Changes in skin colour
• Redness of skin
• Decreased level of phosphate in the blood
• 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 haemoglobin in the blood
• Increased levels of liver enzymes 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
• Increased level of the pancreatic enzyme lipasein the blood, which may be a sign of pancreas problems
• Decreased level of white blood cells in the blood
• Pain in back, arms or legs

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

• Infection of the nose and throat
• Pain in the mouth and throat
• Hair loss
• Excessive sweating during the night
• Anxiety
• Changes in ability to taste
• Changed or irregular heart beat
• Shortness of breath
• Muscle spasms
• Increased level of the pancreatic enzyme, amylase in the blood
• Increased level of creatinine in the blood, which may be sign of the kidney problems
• Increased level of the liver enzyme gamma glutamyltransferase in the blood
• Increased level of white blood cells in the blood
• Increased level of liver enzymes in the blood
• Increased level of alkaline phosphatase in the blood
• Increased level of blood glucose in the blood

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

• Increased levels of potassium, phosphate, and uric acid in the blood, which are signs of cancer cells dying
• Chest discomfort or pain, which may be a sign of heart problems
• Heart failure (shortness of breath, chest discomfort, swelling of legs and ankles)
• Changes in the electrical activity of the heart that can lead to serious irregular heart rhythms.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 label and carton after EXP. The expiry date refers to the last day of that month.

Unopened vials should be stored at 2 C to 8 C.

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

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

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

Do not store any unused medicine for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements. These measures will help protect the environment.

What KIMMTRAK contains

• The active substance is tebentafusp. One vial of 0.5 mL concentrate contains 100 micrograms of tebentafusp.
• The other ingredients are citric acid monohydrate (E330), di-sodium hydrogen phosphate (E339), mannitol (E421), trehalose, polysorbate 20 (E432), and water for injections (see section 2).

What KIMMTRAK looks like and contents of the pack KIMMTRAK concentrate for solution for infusion (sterile concentrate) 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 Ireland Limited Unit 1, Sky Business Centre Dublin 17, D17 FYIreland

Manufacturer Baxter Oncology GmbH Kantstra e 2 33790 Halle/Westfalen Germany

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

BE, BG, CZ, DE. DK, EE, IE, FR, HR, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, RO, SI, SK, FI, SE, UK-NI: Immunocore Ireland Limited EL:

Medison Pharma Greece

: +30 210 0100 /Irsko/Irland/ /Iirimaa/Irlanti/Irl ande/Irska/ rorsz g/ rland/Irlanda/Airija/ rija/L- Irlanda/Ierland/Irlandia/ rsko/Irska T l/Tel/Tel./Te ./Tlf/ /S mi/Puh: +3531 5This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: