Skyrizi 360 mg solution for injection in cartridge

• 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.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract. If you have active Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large bowel. If you have active ulcerative colitis you will first be given other medicines. If these medicines do not work well enough or if you cannot take these medicines, you will be given Skyrizi to treat your ulcerative colitis.

Skyrizi reduces the inflammation and can therefore help to reduce the signs and symptoms of your disease.

• 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 and adolescents under 16 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 0.24 mg of polysorbate 20 in each 180 mg dose and 0.48 mg of polysorbate 20 in each 360 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 cartridge, that is to say essentially ‘sodium-free’.

You will begin treatment with Skyrizi with a starting dose which will be given by your doctor or nurse through a drip in your arm (intravenous infusion).

Crohn’s disease

How much?

• 600 mg
• 600 mg
• 600 mg

When?

• When your doctor tells you
• 4 weeks after 1^st dose
• 4 weeks after 2^nd dose

Ulcerative colitis

How much?

• 1 200 mg
• 1 200 mg
• 1 200 mg

When?

• When your doctor tells you
• 4 weeks after 1^st dose
• 4 weeks after 2^nd dose

Afterwards, you will receive Skyrizi as an injection under your skin.

Crohn’s disease

How much?

• 1^st maintenance dose: 360 mg
• Further doses: 360 mg

When?

• 4 weeks after the last starting dose (at week 12)
• Every 8 weeks, starting after the 1^st maintenance dose

Ulcerative colitis

How much?

• 1^st maintenance dose: 180 mg or 360 mg
• Further doses: 180 mg or 360 mg

When?

• 4 weeks after the last starting dose (at week 12)
• Every 8 weeks, starting after the 1^st maintenance dose

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.

Skyrizi 180 mg solution for injection in cartridge

• Each cartridge contains 180 mg of risankizumab in 1.2 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 360 mg solution for injection in cartridge

• Each cartridge contains 360 mg of risankizumab in 2.4 mL solution (150 mg/mL).
• 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 cartridge. The liquid may contain tiny white or clear particles.

Each pack contains 1 cartridge and 1 on-body injector.

• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the cartridge in the original carton in order to protect from light.
• 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
• The single use on-body injector is designed for use with Skyrizi cartridge only
• 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 at least 45 up to 90 minutes before injecting
  • The on-body injector will not work if Skyrizi is not left at room temperature to warm for at least 45 minutes
• Do not let the on-body injector get wet with water or any other liquids
• Do not touch the start button until you place the on-body injector loaded with the cartridge onto your skin and are ready to inject
  • You can only press the start button one time
• Physical activity should be limited during the injection process. Moderate physical activities can be done, such as walking, reaching and bending
• Do not delay in injecting the medicine after loading the cleaned cartridge into the on-body injector. Waiting will dry out the medicine and the on-body injector will not work afterwards
• 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 carton, cartridge or on-body injector
• If you have any questions on the use of the cartridge or on-body injector, speak to your doctor, pharmacist or nurse for assistance

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 cartridge or on-body injector has been dropped or damaged
• if the carton perforations are broken
• if the white paper tray cover is broken or missing

STEP 1 - Get ready

Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for at least 45 up to 90 minutes before injecting.

• The on-body injector will not work if Skyrizi is not left at room temperature to warm for at least 45 minutes
• Check expiration date (EXP) on the carton. Do not use Skyrizi if the expiration date (EXP) has passed
• Do not remove the cartridge or on-body injector 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

Gather all supplies and wash your hands

Place the following items on a clean, flat surface.

• plastic tray containing 1 on-body injector and 1 cartridge
• 2 alcohol pads (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.

Remove the white paper tray seal

• Locate the black arrow
• Peel away the white paper tray seal from the plastic tray

Lift the plastic cover

• Locate the rounded opening on the top cover
• Insert your index finger in the opening and place your thumb on the opposite side
• Lift the cover to remove and set it aside
• Do not touch the grey start button until it is time to inject. It can only be pressed one time

Inspect the on-body injector

• Check that the on-body injector is intact and not damaged
• The grey door should be slightly open
• If the grey door does not open, press in firmly on the grey door ridges (left side of door) and swing open the door
• Do not close the grey door before the cartridge is loaded
• Do not use on-body injector if you drop it, discover missing pieces, or if it’s damaged
• Do not touch the grey start button until it is time to inject. It can be pressed one time only
• Do not touch the needle cover area or needle

If the grey start button is pressed before placing it on your body, the on-body injector can no longer be used. If this happens, speak to your doctor, pharmacist or nurse.

Proceed to the next step.

STEP 2 - Set up on-body injector

Fully open the grey door

• Avoid touching the needle cover area on the back of the on-body injector. The needle is behind the needle cover
• Swing the grey door all the way to the right to open it
• If the grey door does not open, press in firmly on the grey door ridges (left side of door) and swing open the door
• Do not close the grey door before the cartridge is loaded
• Do not touch the grey start button until it is time to inject. It can only be pressed one time

Put the on-body injector aside.

Inspect the cartridge

• Do not twist or remove cartridge top

Carefully remove the cartridge from the plastic tray.

Check the cartridge

• The liquid should look clear to yellow and may contain tiny white or clear particles. It is normal to see one or more bubbles
• Do not use if the liquid is cloudy, discoloured, or contains flakes or large particles
• The cartridge parts and the clear plastic are not cracked or broken
• Do not use if the liquid has been frozen (even if thawed).
• Do not use the cartridge if you drop it, discover missing pieces, or it is damaged.

Clean the smaller bottom tip of the cartridge

Locate the smaller bottom tip of the cartridge.

• Clean smaller bottom tip of the cartridge with an alcohol pad. Make sure to use the alcohol pad to clean the centre of the smaller bottom tip of the cartridge
• Do not touch the smaller bottom tip of the cartridge after cleaning

Load the cleaned cartridge into the on-body injector

• Do not twist or remove the cartridge top
• Do not touch the grey start button until it is time to inject. It can only be pressed one time
• Insert the smaller bottom tip of the cartridge into the on-body injector first
• Firmly push down on the cartridge top until you hear a “click” and it is fully inserted
• After loading the cartridge, you may see a few drops of medicine on the back of the on-body injector. This is normal

Make sure to proceed to the next step without delay after inserting the cartridge. Waiting will dry out the medicine and the on-body injector will not work afterwards.

Confirm cartridge is inserted and close the grey door

• Confirm the cartridge is fully inserted
• Do not close the grey door if the cartridge is not fully inserted or is missing
• Swing the grey door to the left, then squeeze firmly and listen for the grey door to "snap" shut. No gaps should exist between the grey door and the on-body injector
• The grey door should stay locked after loading the cartridge

Do not touch the grey start button until it is time to inject. It can only be pressed one time.

Proceed without delay to the next step.

STEP 3 - Prepare to inject

Choose and clean your injection site

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)

Do not inject into areas of the skin that naturally fold or bulge because the on-body injector could fall off during wear.

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 placing the on-body injector on the skin
• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. You can trim the excessive hair from the injection site

Peel both tabs to expose skin adhesive

Turn the on-body injector over to find both green pull tabs

• Avoid touching the needle cover (needle inside)

Peel away the large section using the green pull tab to expose the skin adhesive.

Peel away the small section using the green pull tab to expose the skin adhesive. This will remove the clear plastic strip, activating the on-body injector.

• Check the status light when the on-body injector beeps
• The status light will flash blue when the on-body injector is activated
• If the status light does not flash blue, speak to your doctor, pharmacist or nurse
• Do not press the grey start button yet
• Do not touch the needle cover or the needle
• Do not pull the adhesive material off on-body injector or allow the sticky side to fold and stick to itself

The Skyrizi on-body injector must be placed on the skin and injection must be started within 30 minutes after removing the green pull tabs or it will not work. Make sure to proceed to next step without delay.

If the status light flashes red and beeps, the on-body injector is not working properly. Do not continue to use it.

Speak to your doctor, pharmacist or nurse for assistance.

If the on-body injector is attached to your body, carefully remove it from your skin.

Prepare the on-body injector for placement

• For the belly (abdomen), move and hold the skin to create a firm, flat surface for injection at least 5 cm from your belly button (navel). Make sure to sit up straight to avoid skin folds and bulges
• You do not need to pull the skin flat for the front of left thigh or right thigh

Make sure to place the on-body injector so that you can see the blue status light.

Place the on-body injector on your skin

• When the blue light flashes, the on-body injector is ready. Place the on-body injector onto the cleaned skin with the status light visible
• Do not place the on-body injector on clothes. Only place on bare skin
• Run your finger around the adhesive material to secure it
• Do not move or adjust the on-body injector after it has been placed on your skin

Proceed without delay to the next step.

STEP 4 - Inject Skyrizi

Start injection

• Do not touch the grey start button until you place the on-body injector loaded with the cartridge onto your skin and are ready to inject. You can only press the start button one time
• Firmly press the grey start button until you hear a "click". Then release the grey start button
• You may feel a needle pinch
• Check the status light when the on-body injector beeps
• After starting the injection, the status light will continuously flash green
• After starting the injection, you will hear pumping sounds as the on-body injector delivers the medicine

Do not continue to use the on-body injector if status light flashes red and beeps. Carefully remove from skin if the status light flashes red. If this happens, speak to your doctor, pharmacist or nurse.

Wait for the injection to finish

• It may take up to 5 minutes to complete the full dose of medicine. The on-body injector will automatically stop when the injection is finished
• During the injection, the status light will continue to flash green
• During the injection, you will hear pumping sounds as the on-body injector continues delivering the medicine
• During the injection, moderate physical activities can be done, such as walking, reaching and bending

Do not continue to use the on-body injector if the status light flashes red and beeps. Carefully remove it from the skin if the status light flashes red. If this happens, speak to your doctor, pharmacist or nurse.

Injection is complete when

• The on-body injector stops on its own
• You hear a beep and the status light changes to solid green. If the status light has changed to solid green, this means that the injection is complete

Remove the on-body injector

• Do not remove the on-body injector if the status light is still flashing green and the injection is not finished
• Do not put your fingers on the back side of the on-body injector when removing it from your skin
• When the injection is done, grab the corner of the adhesive to carefully peel the on-body injector from the skin
• Avoid touching the needle cover or needle on the back of the on-body injector
• After removing the on-body injector, you will hear several beeps and the status light will turn off
• The needle cover will cover the needle when the on-body injector is removed from the skin
• It is normal to see a few small drops of liquid on your skin after removing the on-body injector
• Press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds
• Do not rub the injection site
• Slight bleeding at the injection site is normal

Proceed to the next step.

STEP 5 - Finish

Check the on-body injector

Inspect the medicine window and status light.

Check to see that the white plunger fills the entire medicine window and the solid green light turns off, letting you know that all the medicine has been injected.

• If the white plunger does not fill the window, speak to your doctor, pharmacist or nurse

Disposal

Throw away the used on-body injector in a special disposal container straight after use.

• The on-body injector contains batteries, electronics, and a needle
• Leave the cartridge in the on-body injector
• Do not throw away the used on-body injector in the household waste
• Your doctor, pharmacist or nurse will tell you how to return the full special disposal container. There may be local guidelines for disposal

Additional information

• On-body injector operating temperature range is 18°C to 28°C and relative humidity range 25% to 75%
• Altitude range is minus 400 metres to 3 200 metres

Symbol Description

Keep Dry

Do not use if package is damaged and consult instructions for use.

Single sterile barrier system

Medical Device

Do not reuse

Manufacturer

Date of Manufacture

Serial Number

Lot Number

Reference Number

Refer to instruction Manual/Booklet

CE Mark

Sterilised using ethylene oxide

Type BF Applied Part

Authorised representative in European Community/European Union