Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kyntheum

Document Subject

Generated Narrative: MedicinalProductDefinition mp32bfd365b84c64d962132c327f20aa6e

identifier: http://ema.europa.eu/identifier/EU/1/16/1155/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kyntheum 210 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-32bfd365b84c64d962132c327f20aa6e

identifier: http://ema.europa.eu/identifier/EU/1/16/1155/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - kyntheum

Attesters

What is in this leaflet

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

Kyntheum contains the active substance brodalumab. Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body.

Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of IL-17 proteins, which are present at increased levels in diseases such as psoriasis.

Kyntheum is used to treat a skin condition called plaque psoriasis , which causes inflammation and scaly plaque formation on the skin. Kyntheum is used in adults with moderate to severe plaque psoriasis affecting large areas of the body.

Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain.

Do not use Kyntheum

• if you are allergic to brodalumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using Kyntheum
• if you have active Crohn s disease
• if you have an infection which your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Kyntheum:

• if you have an inflammatory disease affecting the gut named Crohn s disease

• if you have an inflammation of the large intestine named ulcerative colitis

• if you have ever had or are having suicidal thoughts or actions, depression, anxiety, or mood problems

• if you have an infection now or often get infections eDoc-000624731 - Version 28. 0

• if you have a long-term (chronic) infection

• if you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB. You may be treated with another medicine for TB before you begin treatment with Kyntheum

• if you have recently received or are scheduled to receive a vaccination. You should not be given certain types of vaccines (called live vaccines ) while being treated with Kyntheum

• if you have used Kyntheum during the last three months of your pregnancy, you should talk to your doctor before vaccinating your baby

• if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.

After starting Kyntheum, tell your doctor, pharmacist or nurse immediately:

• if you have been told by your doctor that you have developed Crohn s disease
• if you feel depressed, anxious, or have thoughts of suicide, or have unusual mood changes
• if you have an infection or have any signs of infection listed in Section 4 Possible side effects
• if you have been told you have tuberculosis.

Inflammatory bowel disease (Crohn s disease or ulcerative colitis) Stop using Kyntheum and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (any signs of bowel problems).

Look out for allergic reactions Kyntheum can potentially cause serious side effects, including allergic reactions. You must look out for signs of these conditions while you are taking Kyntheum.

Stop using Kyntheum and tell your doctor or seek medical help immediately if you notice any signs indicating an allergic reaction. Such signs are listed under Serious side effects in section 4. Children and adolescents Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group.

Other medicines and Kyntheum Tell your doctor or pharmacist:

• if you are taking, have recently taken or might take any other medicines.
• if you have recently had or you or your baby are going to have a vaccination, see "Warnings and precautions" in section 2 "What you need to know before using Kyntheum".

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Kyntheum has not been tested in pregnant women and it is not known if this medicine can harm your unborn baby. It is therefore preferable to avoid the use of Kyntheum during pregnancy. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use adequate contraception while using Kyntheum and for at least 12 weeks after the last dose of Kyntheum.

It is not known whether brodalumab passes into breast milk. Tell your doctor if you are breast-feeding or plan to breast-feed. Your doctor will then help you decide whether to stop breast-feeding or stop using Kyntheum. Together you will consider the benefit of breast-feeding to the baby and the benefit of Kyntheum to you.

Driving and using machines Kyntheum is unlikely to affect your ability to drive and use machines.

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Kyntheum should be prescribed to you by a doctor with experience in diagnosing and treating psoriasis.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much Kyntheum is given

• Your doctor will decide how much Kyntheum you need and for how long. The recommended dose is 210 mg (one injection).
• After the first dose you will need to have a weekly injection at Week 1 (one week after the first dose) and Week 2 (two weeks after the first dose). After that, you will need to have an injection every two weeks.
• Kyntheum is for long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. Tell your doctor if you think your signs and symptoms of psoriasis are not improving after using Kyntheum.

How is Kyntheum given Kyntheum is given as an injection under the skin (known as a subcutaneous injection).

Self-administration instructions See the detailed Instructions for Use that comes with this medicine for information on the right way to store, prepare, and give your injections at home.

• If your doctor decides that you or a caregiver can give the injections at home, you or your caregiver should receive training on the right way to prepare and inject Kyntheum. Do not try to inject Kyntheum until you or your caregiver have been shown how to inject Kyntheum by your doctor or nurse.
• Do not shake the pre-filled syringe before use.
• Kyntheum is injected in your upper legs (thighs) or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection in your upper, outer arm.
• Do not inject into an area of the skin that is tender, bruised, red, hard or in an area of skin that is affected by psoriasis.

If you use more Kyntheum than you should If you use more of this medicine than prescribed or take the dose sooner than required, tell your doctor.

If you forget to use Kyntheum If you have forgotten to inject a dose of Kyntheum, inject the next dose as soon as you can after the missed dose. Then, talk to your doctor about when you should inject the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Kyntheum You should not stop using Kyntheum without speaking to your doctor first. If you stop treatment, symptoms of psoriasis may come back.

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

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

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Serious side effects

Stop using Kyntheum and tell your doctor or seek medical help immediately if you get any of the following side effects. Your doctor will decide if and when you may restart the treatment:

Serious allergic reaction (may affect up to 1 in 1,000 people), the signs may include:

• difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or light-headedness
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps.

Possible serious infections (may affect up to 1 in 100 people), the signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, cough which will not go away
• warm, red and painful skin, or a painful skin rash with blisters.

Other side effects

Common (may affect up to 1 in 10 people)

• diarrhoea
• feeling sick
• redness, pain, itching, bruising, or bleeding at injection site
• tiredness
• mouth or throat pain
• tinea (fungal) skin infections (including on feet and groin)
• flu (influenza)
• headache
• joint pain
• muscle pain.

Uncommon (may affect up to 1 in 100 people)

• candida (fungal) infection in the mouth, throat or genitals
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• low white blood cell count.

Most of these side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, nurse, or pharmacist.

Abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems) have also been reported with IL-17 inhibitors, such as Kyntheum.

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 outer carton and label of the pre- filled syringe after EXP. The expiry date refers to the last day of that month.

Keep the pre-filled syringe in the outer carton in order to protect from light.
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Store in a refrigerator (2 C to 8 C). Do not freeze.

Kyntheum can be kept at room temperature up to 25 C in the outer carton for 14 days. Throw away Kyntheum if it is not used within 14 days of storage at room temperature.

Do not use this medicine if you notice the solution is cloudy or discoloured or contains lumps, flakes or particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Kyntheum contains

• The active substance is brodalumab. Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
• The other ingredients are proline, glutamate, polysorbate 20 and water for injections.

What Kyntheum looks like and contents of the pack Kyntheum is a solution for injection that is a clear to slightly pearly, colourless to slightly yellow liquid, with no particles.

Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks comprising 3 cartons, each containing 2 pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder LEO Pharma A/S Industriparken DK-2750 Ballerup Denmark

Manufacturer Laboratoires LEO
39 route de Chartres 28500 Vernouillet France

LEO Pharma A/S Industriparken DK-2750 Ballerup Denmark

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

Belgi /Belgique/Belgien LEO Pharma N.V./S.A T l/Tel: +32 3 740 7Lietuva LEO Pharma A/S Tel: +45 44 94 58
LEO Pharma A/S Te .: +45 44 94 58 Luxembourg/Luxemburg LEO Pharma N.V./S.A T l/Tel: +32 3 740 7eDoc-000624731 - Version 28. 0

esk republika LEO Pharma s.r.o. Tel: +420 734 575 Magyarorsz g LEO Pharma A/S Tel: +45 44 94 58 Danmark LEO Pharma AB Tlf: +45 70 22 49 Malta LEO Pharma A/S Tel: +45 44 94 58 Deutschland LEO Pharma GmbH Tel: +49 6102 2Nederland LEO Pharma B.V. Tel: +31 205104Eesti LEO Pharma A/S Tel: +45 44 94 58 Norge LEO Pharma AS Tlf: +47 22514
LEO Pharmaceutical Hellas S.A. : +30 210 68 34 sterreich LEO Pharma GmbH Tel: +43 1 503 6Espa a Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3Polska LEO Pharma Sp. z o.o. Tel.: +48 22 244 18 France Laboratoires LEO
T l: +33 1 3014 4Portugal LEO Farmac uticos Lda.
Tel: +351 21 711 0Hrvatska LEO Pharma A/S Tel: +45 44 94 58 Rom nia LEO Pharma A/S Tel: +45 44 94 58 Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8Slovenija LEO Pharma A/S Tel: +45 44 94 58 sland Vistor hf. S mi: +354 535 7Slovensk republika LEO Pharma s.r.o. Tel: +420 734 575 Italia LEO Pharma S.p.A Tel: +39 06 52625Suomi/Finland LEO Pharma Oy Puh/Tel: +358 20 721 8
The Star Medicines Importers Co. Ltd. : +357 2537 1Sverige LEO Pharma AB Tel: +46 40 3522 Latvija LEO Pharma A/S Tel: +45 44 94 58 United Kingdom (Northern Ireland) LEO Laboratories Ltd Tel: +44 (0) 1844 347This leaflet was last revised in

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Other sources of information

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