Skyrizi 150 mg solution for injection in pre-filled pen

This leaflet has been written for the person taking the medicine. If you are the parent or caregiver who will give Skyrizi to a child or adolescent, please read this information carefully.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Plaque psoriasis in adults

Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Plaque psoriasis in children and adolescents

Skyrizi is used to treat children and adolescents from 6 to less than 18 years of age with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Psoriatic arthritis

Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis.

Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.

• if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
• if you have an infection, including active tuberculosis, which your doctor thinks is important.

Talk to your doctor, pharmacist, or nurse before and during the use of Skyrizi:

• if you currently have an infection or if you have an infection that keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.

Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions

Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).

Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:

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

Skyrizi is not recommended for children under 6 years of age with plaque psoriasis.

Skyrizi is not recommended for children and adolescents under 18 years of age with psoriatic arthritis.

This is because Skyrizi has not been studied in this age group.

Tell your doctor, pharmacist, or nurse:

• if you are using, have recently used or might use any other medicines.
• if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist, or nurse before and during the use of Skyrizi.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Skyrizi is not likely to affect your driving and use of machines.

This medicine contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per pre-filled pen, that is to say essentially ‘sodium-free’.

Plaque psoriasis in adults

Adults

How much and how often to take?

Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks.

Plaque psoriasis in children and adolescents

Age and body weight

Children and adolescents 6 to less than 18 years of age weighing at least 40 kg

How much and how often to take?

Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks.

Age and body weight

Children and adolescents 6 to less than 18 years of age weighing less than 40 kg

How much and how often to take?

Each dose is 55 mg given as a single injection. A 55 mg pre-filled syringe is available.

After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks.

Psoriatic arthritis in adults

Adults

How much and how often to take?

Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks.

You and your doctor, pharmacist, or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist, or nurse. A caregiver may also give your injection after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.

If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.

Symptoms of a serious infection such as:

• 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

Your doctor will decide if you can keep using Skyrizi.

Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people

• upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people

• feeling tired
• fungal skin infection
• injection site reactions (such as redness or pain)
• itching
• headache
• rash
• eczema

Uncommon: may affect up to 1 in 100 people

• small raised red bumps on the skin
• hives (urticaria)

If you get any side effects, talk to your doctor or pharmacist. 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.

• The active substance is risankizumab. Each pre-filled pen contains 150 mg of risankizumab in 1 mL solution.
• The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

Skyrizi is a clear and colourless to yellow liquid in a pre-filled pen. The liquid may contain tiny white or clear particles.

Each pack contains 1 pre-filled pen.

• You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
  • In children and adolescents 10 to less than 18 years of age, it is recommended that Skyrizi is given by or under supervision of an adult
  • In children 6 to less than 10 years of age, Skyrizi should be given by an adult
• Mark the dates on your calendar so you know when to inject Skyrizi
• Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
• Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting
• Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
• Do not shake the pen
• Wait to remove the dark grey cap until just before the injection

Return this medicine to the pharmacy

• if the expiry date (EXP) has passed
• if the liquid has ever been frozen (even if thawed)
• if the pen has been dropped or damaged
• if the carton perforations are broken

STEP 1

Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting.

• Do not remove the pen from the carton while allowing Skyrizi to reach room temperature
• Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water

Do not use the pen if liquid has been frozen, even if it has been thawed

STEP 2

Place the following items on a clean, flat surface:

• 1 pre-filled pen
• 1 alcohol pad (not included in the carton)
• 1 cotton ball or gauze pad (not included in the carton)
• special disposal container (not included in the carton)

Wash and dry your hands.

STEP 3

Choose from these 3 areas to inject:

• front of left thigh
• front of right thigh
• your belly (abdomen) at least 5 cm from your belly button (navel)

Before the injection, wipe where you will inject in a circular motion with an alcohol pad.

• Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting
• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks

Do not inject into areas affected by psoriasis

STEP 4

Hold the pen with the dark grey cap pointing up, as shown.

• Pull the dark grey cap straight off
• Throw the dark grey cap away

Check the liquid through the inspection window.

• It is normal to see bubbles in the liquid
• The liquid should look clear to yellow and may contain tiny white or clear particles

Do not use if the liquid is cloudy or contains flakes or large particles

STEP 5

Hold the pen with your fingers on the grey hand grips.

Turn the pen so that the white needle sleeve points toward the injection site and you can see the green activator button.

Gently squeeze the skin at your injection site to make a raised area and hold it firmly.

Place the white needle sleeve straight (90º angle) against the raised injection site.

STEP 6

Hold the pen so that you can see the green activator button and inspection window.

Push and keep pressing the pen down firmly against the raised injection site.

• The pen will activate only if the white needle sleeve is pressed down against the injection site before pressing the green activator button

Press the green activator button and hold the pen for 15 seconds.

• A loud “click” means the start of the injection

STEP 7

Keep pressing the pen down firmly against the injection site until the injection is complete.

This takes up to 15 seconds.

The injection is complete when:

• the pen has made a second “click” or
• the yellow indicator has filled the inspection window

STEP 8

When the injection is complete, slowly pull the pen out from the skin.

The white needle sleeve will cover the needle tip and make another “click.”

After completing the injection, place a cotton ball or gauze pad on the skin at the injection site.

• Do not rub the injection site

Slight bleeding at the injection site is normal

STEP 9

Throw away the used pen in a special disposal container straight after use.

• Do not throw away the used pen in the household waste
• Your doctor, pharmacist or nurse will tell you how to return the full special disposal container