Skyrizi 150 mg solution for injection in pre-filled pen

• 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

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.

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.

Allergic reactions

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
• severe itching of the skin, with a red rash or raised bumps

Skyrizi is not recommended for children and adolescents under 18 years of age. 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 less than 1 mmol sodium (23 mg) per pre-filled pen, that is to say essentially ‘sodium-free’.

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.

Talk to your doctor or get medical help immediately if you have 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, 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

• 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.

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
• 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

• 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 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 against the injection site.

The injection is complete when:

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

This takes up to 15 seconds.

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