Kyntheum 210 mg solucion inyectable en jeringa precargada

Patient Information Leaflet

Kyntheum210mg pre-filled syringe solution for injection

brodalumab

Read this 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Kyntheum is and what it is used for

2. What you need to know before you start using Kyntheum

3. How to use Kyntheum

4. Possible side effects

5. Storage of Kyntheum

6. Contents of the pack and additional information

Kyntheum contains the active ingredient brodalumab. Brodalumab is a monoclonal antibody, a type of differentiated protein that recognizes and binds to certain proteins in the body.

Brodalumab belongs to a group of medications known as interleukin (IL) inhibitors. This medication 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 condition called "plaque psoriasis", which causes skin inflammation and the formation of scaly plaques. Kyntheum is indicated for adults with moderate to severe plaque psoriasis affecting extensive areas of the body.

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

Do not use Kyntheum

• If you are allergic to brodalumab or any of the other components of this medication (listed in section6). If you suspect you are allergic, consult your doctor before using Kyntheum.
• If you have active Crohn's disease.
• If you have an infection that your doctor considers important (for example, active tuberculosis).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Kyntheum:

• If you have an inflammatory bowel disease called Crohn's disease.
• If you have an inflammation of the large intestine called ulcerative colitis.
• If you have ever had or have suicidal thoughts, depression, anxiety, or emotional instability.
• If you have any current infection or are prone to infections.
• If you have any chronic infection.
• If you have tuberculosis (TB), have tested positive for TB, or have been in direct contact with someone with TB. You may need to be treated with a TB medication before starting treatment with Kyntheum.
• If you have recently received any vaccine or have a scheduled vaccination. Certain types of vaccines (live vaccines) 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, consult your doctor before vaccinating your baby.
• If you are receiving any other treatment for psoriasis, such as another immunosuppressant or ultraviolet (UV) light therapy.

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

• If your doctor has told you that you have developed Crohn's disease.
• If you feel depressed or nervous, have suicidal thoughts, or exhibit unusual emotional changes.
• If you have any infection or exhibit any of the signs of infection listed in section4, “Possible side effects”.
• If you have been informed that you have tuberculosis.

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

Stop taking Kyntheum and inform your doctor or seek medical assistance immediately if you notice abdominal pain, cramps, diarrhea, weight loss, or blood in your stool (any sign of intestinal problems).

Watch for allergic reactions

Kyntheum may potentially cause severe side effects, including allergic reactions. You must watch for the appearance of these signs and symptoms while using Kyntheum.

Interrupt treatment with Kyntheum and inform yourdoctor or seek medical assistance immediately if you notice any of thesigns indicating a possible allergic reaction.These signs are listed in section 4 “Severe side effects”.

Children and adolescents

Kyntheum is not recommended for children and adolescents (under18years), as it has not been studied in this age group.

Other medications and Kyntheum

Inform your doctor or pharmacist:

• If you are taking, have recently taken, or may need to take any other medication.
• If you have recently received a vaccine or are scheduled to receive a vaccine; consult “Warnings and precautions” in section2. “What you need to know before starting to use Kyntheum”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Kyntheum has not been studied in pregnant women and its potential harm to the fetus is unknown. Therefore, it is preferable to avoid using Kyntheum during pregnancy. If you are fertile, it is recommended that you avoid becoming pregnant and use an appropriate contraceptive while using Kyntheum and for at least12weeks after the last dose of Kyntheum.

The passage of brodalumab into breast milk is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor. In this case, your doctor will help you decide whether to stop breastfeeding or stop using Kyntheum. Together, you will weigh the benefits of breastfeeding for the baby and the benefits of Kyntheum for you.

Driving and operating machinery

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again.

What amount of Kyntheum is administered

• Your doctor will decide the amount of Kyntheum you need and the duration of treatment. The recommended dose is210mg (one injection).
• After the first dose, you will need to administer an injection weekly in week1(one week after the first dose) and in week2(two weeks after the first dose). After that, you will need to administer an injection every two weeks.
• Kyntheum is a long-term treatment medication. Your doctor will monitor your condition periodically to ensure that the treatment has the desired effect. Inform your doctor if you believe that the psoriasis symptoms do not improve after using Kyntheum.

How Kyntheum is administered

Kyntheum is administered through an injection under the skin (denominated subcutaneous injection).

Self-administration instructions

Consult the detailed “Usage Instructions”provided with this medication to know how to store, prepare and administer the injections correctly at home.

• If your doctor decides that you or a caregiver can administer the injections at home, you will be instructed on how to prepare and inject Kyntheum correctly. Do not attempt to inject Kyntheum until your doctor or nurse has indicated to you or your caregiver how to administer the Kyntheum injections.
• Do not shake the pre-filled syringe before use.
• You or your caregiver can administer Kyntheum injections in the upper part of your legs (thighs) or in the abdomen. The caregiver can also administer the injection in the upper outer part of the arm.
• Do not inject the medication in a sensitive, irritated, red, hardened or psoriasis-affected skin area.

If you use more Kyntheum than you should

Inform your doctor if you use more medication than prescribed or if the dose is administered before the scheduled time.

If you forgot to use Kyntheum

If you forgot to inject a dose of Kyntheum, inject the next dose as soon as possible after the missed dose. Then, ask your doctor when to inject the next dose. Do not administer a double dose to compensate for the missed doses.

If you interrupt the Kyntheum treatment

Do not stop using Kyntheum without first discussing it with your doctor. If you interrupt the treatment, psoriasis symptoms may reappear.

If you have any other doubts about using this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Stop treatment with Kyntheum and inform your doctor or seek immediate medical attention if you notice any of the following side effects. Your doctor will decide whether you should and when you should restart treatment.

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 lightheadedness
• Swelling of the face, lips, tongue, or throat
• Intense itching of the skin accompanied by rash or blisters.

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

• Fever, flu-like symptoms, night sweats
• Feeling tired or difficulty breathing, persistent cough
• Hot, red, and painful skin, or painful rash with blisters

Other side effects

Frequent (may affect up to 1in 10people)

• Diarrhea
• Nausea
• Redness, pain, itching, irritation, or bleeding at the injection site
• Tiredness
• Sore throat or mouth
• Skin infections caused by fungi (including feet and groin)
• Influenza (flu)
• Headache
• Joint pain
• Muscle pain

Rare (may affect up to 1in 100people)

• Candida infection (fungus) in the mouth, throat, or genitals
• Eye secretion 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 seem severe, inform your doctor, pharmacist, or nurse.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through theAppendix Vnational notification system included in thelink. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on theouter packaging and on the pre-filled syringe label after EXP. The expiration date is the last day of the month indicated.

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

Store in the refrigerator (between2°C and8°C). Do not freeze.

Kyntheum can be stored at room temperature up to25°C in the outer packaging for14days. Dispose of Kyntheum if it is not used within a maximum period of14days of storage at room temperature.

Do not use this medication if you observe that the solution is cloudy, has lost color, or contains lumps, flakes, or particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Kyntheum

• The active ingredient is brodalumab. Each pre-filled syringe contains210mg of brodalumab in1.5ml of solution.
• The other components are proline, glutamate, polisorbate20and water for injection.

Appearance of the product and contents of the pack

Kyntheum is a transparent or slightly opalescent, colourless or slightly yellowish solution that does not contain particles.

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

Marketing Authorisation 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 about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for use:

Kyntheum (brodalumab)

Pre-filled syringe solution for injection

Subcutaneous administration

Kyntheum is presented in a single-use pre-filled syringe. Each pre-filled syringe contains a dose of Kyntheum of210mg.Your doctor, pharmacist or nurse will tell you how often you should inject the medicine.Each pre-filled syringe ofKyntheumcan only be used once.

If your doctor decides that you or a carer can administer the injections at home, you will be trained on how to prepare and inject Kyntheum correctly. Do not try to inject the medicine until your doctor has told you how to administer the injections correctly.

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

Important:The needle is inside

Important

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

Storage of pre-filled syringesKyntheum

• Maintain out of the sight and reach of children.
• Store in the original packaging to protect it from light or physical damage.
• Store in a refrigerator (between2°C and8°C).
• If necessary, pre-filled syringes of Kyntheum can be stored at room temperature (up to25°C) for a maximum of14days. Dispose of Kyntheum pre-filled syringes that have been stored at room temperature for more than14days.
• Do notfreeze.

Use of pre-filled syringesKyntheum

• Do notuse the syringe after the expiry date stated on the label.
• Do notshake the syringe.
• Do notremove the needle cap until you are ready to administer the injection.
• Do notuse the pre-filled syringe of Kyntheum if it has fallen onto a hard surface. This is done in case the syringe has been broken.

Step1: Preparation

A.Remove the pre-filled syringeKyntheumfrom the pack

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

If there are any syringes left unused, store the pack in the refrigerator.

For safety reasons:

• Do nothold the syringe by the plunger.
• Do nothold the syringe by the needle cap.
• Do notremove the needle cap until you are ready to administer the injection.
• Do notremove the finger supports. They are part of the syringe.

Leave the syringe at room temperature for at least30minutes before injecting the medicine.

• Do notput the syringe back in the refrigerator if it has reached room temperature.
• Do nottry to heat the syringe using a heat source, such as hot water or a microwave.
• Do notexpose the syringe to direct sunlight.
• Do notshake the syringe.

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

B.Examine the pre-filled syringeKyntheum

Always hold the syringe by the barrel.

Make sure the medicine in the syringe is transparent or slightly opalescent and colourless or slightly yellowish.

• Do notuse the syringe if:
• • The medicine is cloudy, has lost its colour or contains lumps or particles.
  • It appears to be broken or cracked in some area.

C.Gather all the necessary materials

Wash your hands thoroughly with soap and water.

On a clean and well-lit work surface, place:

• The new syringe.
• Alcohol wipes.
• Cotton balls or gauze.
• Bandages.
• A sharps container (the colour and appearance of this container may vary depending on national requirements).

D.Prepare and clean the injection site

You or your carer can administer the injection in:

• The thigh.
• The abdomen (except the area around the navel (diameter of5cm)).

Only the carer can administer the injection in:

• The upper outer area of the arm.
  

• Do notinject the medicine in areas where the skin is sensitive, irritated, red or indurated.
• Avoid injecting the medicine in areas with scars or stretch marks.
• Avoid injecting the medicine directly into thick, red, scaly or bumpy skin or lesions.

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

• Do nottouch this area again before injecting the medicine.
• Make sure to use a different injection site if you want to use the same area again.

Step2: Preparation for injection

E. When you are ready to inject the medicine, remove the needle cap with a straight motion in the direction away from your body

Dispose of the needle cap in the sharps container.

• Do nottwist or bend the needle cap.
• Do notput the needle cap back on.

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

F. Pinch the skin to create a firm surface

Hold the skin firmly with your thumb and fingers and create an area of about5cm wide.

Important:Keep holding the skin until you have injected the medicine.

Step3: Injection

G. Hold the skin. Once you have removed the needle cap, insert the syringe into the skin at an angle of between45and90degrees

Do notput your finger on the plunger while inserting the needle.

H. Apply slow but constant pressure to the plunger until it stops moving

I. When you have finished, remove your finger. Then, carefully withdraw the syringe from the skin

Important:If, when withdrawing the syringe, you see that there is still medicine in the syringe barrel, the full dose has not been administered. Call your doctor, pharmacist or nurse immediately.

Step4: Completion

J. Dispose of the used syringe

• Dispose of the used pre-filled syringe in a sharps container immediately after use.
• Do notuse the syringe again.
• Do notrecycle the syringe or the sharps container or throw them away.

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

K. Check the injection site

Press the injection site with a cotton ball or gauze if there is bleeding.Do notrub the injection site. Cover it with a bandage if necessary.