Kyndacel 210 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Kyntheum 210 mg solution for injection in a pre-filled syringe

Brodalumab

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Kyntheum is and what it is used for

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

Brodalumab belongs to a group of medicines known as interleukin (IL) inhibitors. This medicine blocks the activity of IL-17 proteins, which are present at elevated levels in diseases such as psoriasis.

Kyntheum is used to treat a skin disease called "plaque psoriasis", which causes inflammation of the skin and the formation of scaly plaques. Kyntheum is indicated in adults with moderate to severe plaque psoriasis with extensive body surface involvement.

Using Kyntheum will help you achieve improved skin clearance and reduce the signs and symptoms of psoriasis, such as itching, redness, scaling, burning, stinging, cracking, flaking, and pain.

2. What you need to know before using Kyntheum

Do not use Kyntheum

• if you are allergic to brodalumab or to any of the other ingredients of this medicine (listed in section 6). If you suspect you may be allergic, consult your doctor before using Kyntheum.
• if you have active Crohn’s disease.
• if you have an infection that your doctor considers significant (e.g., active tuberculosis).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Kyntheum:

• if you have an inflammatory bowel disease called Crohn’s disease.
• if you have inflammation of the large intestine called ulcerative colitis.
• if you have ever had or currently have suicidal thoughts or ideation, depression, anxiety, or emotional instability.
• if you currently have an infection or are prone to frequent infections.
• if you have a long-term (chronic) infection.
• if you have tuberculosis (TB), tested positive for TB, or have had close contact with someone who has TB. You may need to be treated for TB before starting Kyntheum.
• if you have recently received any vaccine or are scheduled to receive one. Certain types of vaccines (those made with live microorganisms) should not be administered while you are being treated with Kyntheum.
• if you used Kyntheum during the last three months of pregnancy; in this case, you should consult your doctor before vaccinating your baby.
• if you are receiving any other treatment for psoriasis, such as another immunosuppressant or ultraviolet (UV) light phototherapy.

After starting treatment with Kyntheum, inform your doctor, pharmacist, or nurse immediately:

• if your doctor has diagnosed you with Crohn’s disease.
• if you feel depressed or anxious, have suicidal thoughts, or experience unusual emotional changes.
• if you develop any infection or experience any of the signs of infection listed in section 4, “Possible side effects”.
• if you have been diagnosed with tuberculosis.

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)

Stop taking Kyntheum and inform your doctor or seek immediate medical attention if you experience abdominal pain and cramping, diarrhea, weight loss, or blood in your stool (any signs of intestinal problems).

Watch for allergic reactions

Kyntheum may potentially cause serious adverse effects, including allergic reactions. You should monitor for these signs and symptoms while using Kyntheum.

Discontinue treatment with Kyntheum and contact your doctor or seek immediate medical help if you notice any signs of a possible allergic reaction. These signs are listed in section 4, “Serious side effects”.

Children and adolescents

Kyntheum is not recommended for children and adolescents (under 18 years of age), as it has not been studied in this age group.

Other medicines and Kyntheum

Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might need to take any other medicines.
• if you have recently received a vaccine or are scheduled to receive one, either for yourself or your baby; see “Warnings and precautions” in section 2, “What you need to know before using Kyntheum”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Kyntheum has not been studied in pregnant women, and it is unknown whether this medicine could harm the unborn baby. Therefore, it is advisable to avoid using Kyntheum during pregnancy. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use an effective contraceptive method while using Kyntheum and for at least 12 weeks after the last dose.

It is unknown whether brodalumab passes into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor. In such cases, your doctor will help you decide whether to discontinue breastfeeding or stop using Kyntheum, weighing the benefits of breastfeeding for the baby against the benefits of Kyntheum for you.

Driving and using machines

It is unlikely that Kyntheum will affect your ability to drive or operate machinery.

3. How to use Kyntheum

Kyntheum must be prescribed by a doctor experienced in the diagnosis and treatment of psoriasis.

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

How much Kyntheum to administer

• Your doctor will decide how much Kyntheum you need and how long the treatment should last. The recommended dose is 210 mg (one injection).
• After the first dose, you will need to administer one injection in week 1 (one week after the first dose) and in week 2 (two weeks after the first dose). After that, you will need to administer one injection every two weeks.
• Kyntheum is a long-term treatment. Your doctor will monitor your condition periodically to ensure the treatment is having the desired effect. Inform your doctor if you feel that the signs and symptoms of psoriasis are not improving after using Kyntheum.

How Kyntheum is administered

Kyntheum is administered by injection under the skin (called subcutaneous injection).

Instructions for self-administration

Refer to the detailed “Instructions for use” provided with this medicine for information on how to properly store, prepare, and administer the injections at home.

• If your doctor decides that you or a caregiver may administer the injections at home, you will be trained on how to properly prepare and inject Kyntheum. Do not attempt to self-inject Kyntheum until your doctor or nurse has instructed you or your caregiver on how to administer Kyntheum injections.
• Do not shake the pre-filled syringe before use.
• You or your caregiver may inject Kyntheum into the upper legs (thighs) or into the abdomen (abdominal area). A caregiver may also administer the injection into the outer upper arm.
• Do not inject the medicine into areas of skin that are hypersensitive, irritated, red, hardened, or affected by psoriasis.

If you use more Kyntheum than you should

Inform your doctor if you use more medicine than prescribed or if you administered the dose earlier than scheduled.

If you forget to use Kyntheum

If you forget to inject a dose of Kyntheum, inject the next dose as soon as possible after the missed dose. Then, consult your doctor to determine when you should inject the following dose. Do not administer a double dose to make up for missed doses.

If you stop using Kyntheum

You should not stop using Kyntheum without first discussing it with your doctor. If you discontinue treatment, psoriasis symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Stop treatment with Kyntheum and inform your doctor or seek immediate medical help if you notice any of the following adverse effects. Your doctor will decide whether and when treatment should be restarted.

Severe allergic reaction (may affect up to 1 in 1,000 people); symptoms may include:

• difficulty breathing or swallowing
• low blood pressure, which may cause dizziness or mild lightheadedness
• swelling of the face, lips, tongue, or throat
• intense itching (pruritus) of the skin accompanied by rash or blisters

Possible serious infections (may affect up to 1 in 100 people); symptoms may include:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, persistent cough
• skin that is hot, red, and painful, or painful rash with blisters

Other adverse effects

Common (may affect up to 1 in 10 people)

• diarrhoea
• nausea
• redness, pain, itching, irritation, or bleeding at the injection site
• fatigue
• sore throat or mouth
• fungal skin infections (including athlete’s foot and fungal groin infection)
• flu (influenza)
• headache
• joint pain
• muscle pain

Uncommon (may affect up to 1 in 100 people)

• Candida (fungal) infection of the mouth, throat, or genitals
• itchy, red, and swollen eyes with discharge (conjunctivitis)
• low white blood cell count

Frequency not known (cannot be estimated from available data)

• Painful swelling and ulceration of the skin (pyoderma gangrenosum)

Most of these adverse effects are mild to moderate. If any of these adverse effects appear severe, inform your doctor, pharmacist, or nurse.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Kyntheum

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

Do not use this medicine after the expiry date stated on the outer packaging and on the label of the pre-filled syringe after EXP. The expiry date refers to the last day of the month indicated.

Store the pre-filled syringe in the outer packaging to protect it from light.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Kyntheum may be stored at room temperature up to 25 °C, in the outer packaging, for up to 14 days. Discard Kyntheum if not used within 14 days of storage at room temperature.

Do not use this medicine if you notice that the solution is cloudy, has lost its colour, or contains clumps, flakes, or particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kyntheum

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

Nature of the product and contents of the container

Kyntheum is a clear or slightly opalescent, colourless or slightly yellow, injectable solution free from particles.

Kyntheum is available in single packs containing 2 pre-filled syringes and multiple packs containing 3 boxes, each box containing 2 pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorization Holder

LEO Pharma A/S

Industriparken 55

DK‑2750 Ballerup

Denmark

Manufacturer

Laboratoires LEO

39 route de Chartres

28500 Vernouillet

France

LEO Pharma A/S

Industriparken 55

DK‑2750 Ballerup

Denmark

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium LEO Pharma N.V./S.A Tel/Tel: +32 3 740 7868	Lithuania LEO Pharma A/S Tel: +45 44 94 58 88
	Luxembourg/Luxembourg LEO Pharma N.V./S.A Tél/Tel: +32 3 740 7868
Czech Republic LEO Pharma s.r.o Tel: +420 734 575 982	Hungary LEO Pharma A/S Tel.: +45 44 94 58 88
Denmark LEO Pharma AB Tlf.: +45 70 22 49 11	Malta LEO Pharma A/S Tel: +45 44 94 58 88
Germany LEO Pharma GmbH Tel: +49 6102 2010	Netherlands LEO Pharma B.V. Tel: +31 205104141
Estonia LEO Pharma A/S Tel: +45 44 94 58 88	Norway LEO Pharma AS Tlf: +47 22514900
Greece LEO Pharmaceutical Hellas S.A. Tel: +30 212 222 5000	Austria LEO Pharma GmbH Tel: +43 1 503 6979
Spain Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3366	Poland LEO Pharma Sp. z o.o. Tel.: +48 22 244 18 40
France Laboratoires LEO Tél: +33 1 3014 4000	Portugal LEO Farmacêuticos Lda. Tel: +351 21 711 0760
Croatia LEO Pharma A/S Tel: +45 44 94 58 88	Romania LEO Pharma A/S Tel: +45 44 94 58 88
Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8924	Slovenia LEO Pharma A/S Tel: +45 44 94 58 88
Iceland Vistor hf. Tel: +354 535 7000	Slovakia LEO Pharma s.r.o. Tel: +420 734 575 982
Italy LEO Pharma S.p.A. Tel: +39 06 52625500	Finland LEO Pharma Oy Puh/Tel: +358 20 721 8440
Cyprus The Star Medicines Importers Co. Ltd. Tel: +357 2537 1056	Sweden LEO Pharma AB Tel: +46 40 3522 00
Latvia LEO Pharma A/S Tel: +45 44 94 58 88	United Kingdom (Northern Ireland) LEO Laboratories Ltd Tel: +44 (0) 1844 347333

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for use:

Kyntheum (brodalumab)

injectable solution in pre-filled syringe

brodalumab

Administration by subcutaneous injection

Kyntheum is supplied in a single-use pre-filled syringe. Each syringe contains a dose of Kyntheum of 210 mg. Your doctor, pharmacist, or nurse will inform you how often you should inject the medicine. Each pre-filled syringe of Kyntheum can only be used once.

If your doctor decides that you or a caregiver may administer the injections at home, you will be trained on how to properly prepare and inject Kyntheum. Do not attempt to inject the medicine until your doctor has instructed you on how to correctly administer the injections.

Read all instructions before using the pre-filled syringe Kyntheum. Contact your doctor, pharmacist, or nurse if you or your caregiver have any questions about how to correctly inject Kyntheum.

Important: The needle is inside

Before using a pre-filled syringe Kyntheum, read the following instructions:

Storage of pre-filled syringes Kyntheum

• Keep out of the sight and reach of children.
• Store in the original packaging to protect from light or physical damage.
• Store in the refrigerator (between 2°C and 8°C).
• If necessary, pre-filled syringes of Kyntheum may be stored at room temperature (up to 25°C) for a maximum of 14 days. Pre-filled syringes of Kyntheum that have been stored at room temperature for more than 14 days must be discarded.
• Do not freeze.

Use of pre-filled syringes Kyntheum

• Do not use the syringe after the expiry date stated on the label.
• Do not shake the syringe.
• Do not remove the needle cap until you are ready to administer the injection.
• Do not use the pre-filled syringe Kyntheum if it has fallen on a hard surface. This precaution is in place in case the syringe is broken.

Step 1: Preparation

A. Remove the pre-filled syringe Kyntheum from the carton

Hold the syringe by the barrel to remove it from the tray.

If any syringes remain unused, store the carton in the refrigerator.

For safety reasons:

• Do not hold the syringe by the plunger.
• Do not hold the syringe by the needle cap.
• Do not remove the needle cap until you are ready to administer the injection.
• Do not remove the finger grips. They are part of the syringe.

Allow the syringe to reach room temperature for at least 30 minutes before injecting the medicine.

• Do not return the syringe to the refrigerator once it has reached room temperature.
• Do not try to warm the syringe using a heat source such as hot water or a microwave.
• Do not expose the syringe to direct sunlight.
• Do not shake the syringe.

Important: Always hold the pre-filled syringe by the barrel.

B. Examine the pre-filled syringe Kyntheum

Make sure the medicine in the syringe is clear or slightly opalescent and colourless or slightly yellow.

• Do not use the syringe if:
  • the medicine is cloudy, discoloured, or contains flakes or particles.
  • the syringe appears broken or cracked.

C. Gather all necessary materials

Wash your hands thoroughly with soap and water.

On a clean work surface with good lighting, place:

• the new syringe.
• alcohol wipes.
• cotton balls or gauze pads.
• adhesive bandages.
• a sharps disposal container (the colour and appearance of this container may vary depending on national requirements).

D. Prepare and clean the injection site

You or your caregiver may administer the injection in:

• the thigh
• the abdomen (except the area around the navel, within a 5 cm diameter).

Only the caregiver may administer the injection in:

• the outer upper arm.

About the injection site:

• Do not inject the medicine into areas where the skin is tender, irritated, red, or hardened.

• Avoid injecting the medicine into areas with scars or stretch marks.

• Avoid injecting the medicine directly into thick, red, scaly, or bumpy skin areas or lesions.

• Clean the area where you will inject the medicine with an alcohol wipe. Allow the skin to dry.

• Do not touch this area again before injecting the medicine.

• If you wish to use the same injection site, ensure you do not use exactly the same spot as your previous injection.

Step 2: Preparation for injection

• When ready to inject the medicine, remove the needle cap by pulling it straight off, away from your body.

Dispose of the needle cap in the sharps disposal container.

• Do not bend or twist the needle cap.
• Do not recap the needle.

You may see small air bubbles in the syringe or a drop of liquid at the tip of the needle. Both are normal and do not need to be removed.

• Pinch the skin to create a firm surface.

Firmly grasp the skin with your thumb and fingers to create an area about 5 cm wide.

Important: Continue to hold the skin pinched until the medicine has been injected.

Step 3: Injection

• Hold the skin. After removing the needle cap, insert the syringe into the skin at an angle between 45 and 90 degrees.

Do not place your finger on the plunger while inserting the needle.

• Apply slow but steady pressure on the plunger until it stops moving.

• When finished, remove your thumb. Then carefully withdraw the syringe from the skin.

Important: If, upon removing the syringe, you see that some medicine remains in the syringe barrel, the full dose has not been administered. Contact your doctor, pharmacist, or nurse immediately.

Step 4: Completion

• Dispose of the used syringe.

• Immediately after use, dispose of the used pre-filled syringe in a sharps disposal container that is puncture-resistant.
• Do not reuse the syringe.
• Do not recycle the syringe or the sharps disposal container, or throw them in the household waste.

Important: Keep the sharps disposal container out of the sight and reach of children.

• Check the injection site.

If there is blood, press the injection site with a cotton ball or gauze pad. Do not rub the injection site. Cover with an adhesive bandage if needed.