Skyrizi

Package leaflet: Information for the patient

Skyrizi 150 mg solution for injection in pre-filled pen

risankizumab
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Skyrizi is and what it is used for
2. What you need to know before using 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

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis

How Skyrizi works
This medicine works by blocking 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 the 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 joint inflammation and psoriasis. If you have active psoriatic arthritis, you may initially be given other medicines. If these medicines are not sufficiently effective, you will be given Skyrizi either alone or in combination with other medicines for the treatment of psoriatic arthritis.
Skyrizi reduces inflammation and can therefore help reduce pain, stiffness, and swelling in and around the joints, pain and stiffness of the spine, psoriatic skin rash, psoriatic nail damage, and can slow down damage to the bones and joint cartilage. These effects may help you carry out normal daily activities, reduce fatigue, and improve quality of life.

2. What you need to know before using Skyrizi

Do not use Skyrizi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi:

• if you currently have an infection or if you have an infection that keeps recurring.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You must not receive certain types of vaccines while using Skyrizi.

It is important to record the batch number of your Skyrizi pack.
Each time you receive a new pack of Skyrizi, write down the date and the batch number (found on the pack after “Lot/Lotto”) and keep this information in a safe place.

Severe allergic reactions
Skyrizi may cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Contact your doctor immediately or seek immediate medical help if, during treatment with Skyrizi, you notice any signs of an allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion
• severe itching, with red rash or raised bumps on the skin

Children and adolescents
Skyrizi is not recommended in children and adolescents under 18 years of age, as Skyrizi has not been studied in this age group.

Other medicines and Skyrizi
Inform your doctor, pharmacist, or nurse:

• if you are taking, have recently taken, or might take any other medicines.
• if you have recently received or are due to receive any vaccination. You must not receive certain types of vaccines while using Skyrizi.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during use of Skyrizi.

Pregnancy, contraception, and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine, as it is unknown whether this medicine could harm the unborn baby.
If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with this medicine and for at least 21 weeks after the last dose of Skyrizi.
If you are breastfeeding or intend to breastfeed, consult your doctor before using this medicine.

Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive or operate machinery.

Skyrizi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled pen, i.e. essentially “sodium-free”.

3. How to use Skyrizi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is administered by injection under the skin (subcutaneous injection).
How much Skyrizi to use
Each dose is 150 mg, to be administered as a single injection. After the first dose, you will receive
the next dose 4 weeks later, and then every 12 weeks thereafter.
You may decide, together with your doctor, pharmacist or nurse, to self-administer this
medicine. Do not self-administer this medicine until you have received instructions from your doctor,
pharmacist or nurse. A caregiver may also administer the injection after being properly trained.
Before injecting Skyrizi, carefully read section 7 “Instructions for use”, at the end of
this leaflet.
If you use more Skyrizi than you should
If you have used more Skyrizi than prescribed or if the dose was administered earlier than scheduled,
inform your doctor.
If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, consult your
doctor.
If you stop using Skyrizi
Do not stop using Skyrizi without first talking to your doctor. If you stop treatment, symptoms may
return.
If you have any questions about how to use this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Serious side effects

Allergic reactions – these may require urgent treatment. Immediately inform your doctor or seek immediate medical help if any of the following symptoms occur:

Severe allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000 people). Symptoms include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion

Immediately inform your doctor or seek immediate medical help if any of the following symptoms occur.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, persistent cough
• skin that is warm, red, and painful, or a painful rash with blistering

Your doctor will decide whether you can continue using Skyrizi.

Other side effects

Tell your doctor, pharmacist, or nurse if any of the following side effects occur.

Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

Common: may affect up to 1 in 10 people

• feeling tired
• fungal skin infections
• 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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skyrizi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and on the box after "EXP/Scad".
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
If necessary, the pre-filled pen can also be stored outside the refrigerator (up to 25 °C) for a maximum of 24 hours in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the liquid is cloudy or contains flakes or large particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Skyrizi contains

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

Description of the appearance of Skyrizi and contents of the pack
Skyrizi is a clear, colourless to yellow liquid in a pre-filled pen. The liquid may contain small white or transparent particles.
Each pack contains 1 pre-filled pen.

Marketing Authorisation Holder and Manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel: +36 1 455 8600

Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 22983201

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 91 384 09 10 Tel: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
More detailed and up-to-date information on this medicinal product is available by scanning the QR code shown below or on the outer packaging with a smartphone.
The same information is also available at the following URL:
www.skyrizi.eu
[QR code to be included]
To listen to or request a copy of this summary of product characteristics in , or , please contact the local representative of the Marketing Authorisation Holder.

7. Instructions for Use

Read all of section 7 before using Skyrizi
Skyrizi pre-filled pen
Dark grey cap
(Do not remove until
Green activation button Inspection window Needle time of injection)

Grey gripping areas White needle protective sheath
Important information to know before injecting Skyrizi

• You must receive training on how to inject Skyrizi before administering the injection. If you need help, consult your doctor, pharmacist, or nurse.
• Mark the dates on your calendar so you know when to inject Skyrizi.
• Keep Skyrizi in its original packaging to protect the medicine from light until ready to use.
• Remove the package from the refrigerator and allow it to reach room temperature, protected from direct sunlight, for 30–90 minutes before injecting.
• Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should be clear to yellow and may contain small white or transparent particles.
• Do not shake the pen.
• Wait to remove the dark grey cap until shortly before injection.

Return this medicine to the pharmacy

• after the expiry date (Exp.)
• if the liquid has been frozen (even after thawing)
• if the pen has been dropped or damaged
• if the packaging seals are damaged

Follow these instructions every time you use Skyrizi
STEP 1 Remove the package from the refrigerator and
allow it to reach room temperature, protected from

direct sunlight, for 30–90 minutes before
performing the injection.
Do not remove the pen from the packaging until
Skyrizi has reached room temperature.
Do not heat Skyrizi in any other way.
For example, do not heat Skyrizi in a
microwave or in hot water.
Do not use the pen if the liquid has been
frozen, even if it has subsequently been
thawed.
STEP 2 Place the following items on a clean, flat surface:

1 pre-filled pen
1 alcohol swab (not included in the package)
1 cotton ball or gauze pad (not included in the package)
sharps container (not included in the package)
Wash and dry your hands.
STEP 3 Choose one of these three injection sites:
left front thigh
Injection sites
right front thigh
abdomen (belly), at least 5 cm

from the navel
Before injection, clean the selected area with a
circular motion using an alcohol swab.
Do not touch or blow on the injection site
after cleaning. Allow the skin to dry before
performing the injection.
Do not inject through clothing.
Do not inject into irritated, bruised, red, hardened, scarred, or stretch-marked skin.
Do not inject into areas affected by psoriasis.
Injection sites
STEP 4 Hold the pen with the dark grey cap facing upward, as shown.
Check the liquid Remove the dark grey cap.

Discard the dark grey cap.
~ Check the liquid through the inspection window.
It is normal to see bubbles in the liquid.
The liquid should be clear to yellow and may contain small white or transparent particles.
Do not use if the liquid is cloudy or
contains flakes or large particles.
U
STEP 5 Hold the pen with your fingers on the grey gripping areas.
Abdomen or thigh

Rotate the pen so that the white needle protective sheath faces the injection site and the green activation button is visible.
Gently pinch the skin at the injection site and lift it firmly.
Place the white needle protective sheath against the lifted injection site (at a 90° angle).
STEP 6 Hold the pen so that the green activation button and inspection window are visible.

Press and continue holding the pen firmly against the lifted injection site.
The pen will activate only if the white needle protective sheath is pressed against the injection site before pressing the green activation button.
Press the green activation button and hold the pen in place for 15 seconds.
~ A loud “click” indicates the start of the injection.
STEP 7 Continue holding the pen against the injection site.
Second “click”

The injection is complete when:
the pen emits a second “click” or
the yellow indicator fills the inspection window.
This process takes up to 15 seconds.
Yellow indicator
STEP 8 Once the injection is complete, slowly remove the pen from the skin.

The white needle protective sheath will cover the needle tip and emit another “click”.
After completing the injection, apply a cotton ball or gauze pad to the injection site.
Do not rub the injection site.
Mild bleeding at the injection site is normal.
STEP 9 Dispose of the used pen immediately into a sharps container.

Do not dispose of the used pen in household waste.
Your doctor, pharmacist, or nurse will explain how to return the sharps container once it is full.
\10

Patient Information Leaflet

Skyrizi 150 mg solution for injection in pre-filled syringe

risankizumab
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Skyrizi is and what it is used for
2. What you need to know before using 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

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis

How Skyrizi works
This medicine works by blocking 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 the 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 joint inflammation and psoriasis. If you have active psoriatic arthritis, you may initially be given other medicines. If these medicines are not sufficiently effective, Skyrizi will be given either alone or in combination with other medicines for the treatment of psoriatic arthritis.
Skyrizi reduces inflammation and can therefore help reduce pain, stiffness and swelling in and around the joints, pain and stiffness of the spine, psoriatic skin rash, psoriatic nail damage, and can slow down damage to the bones and joint cartilage. These effects may help you carry out normal daily activities, reduce fatigue, and improve quality of life.

2. What you need to know before using Skyrizi

Do not use Skyrizi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi:

• if you currently have an infection or if you have an infection that keeps recurring.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You must not receive certain types of vaccines while using Skyrizi.

It is important to record the batch number of your Skyrizi pack.
Each time you receive a new pack of Skyrizi, write down the date and the batch number (found on the pack after “Lot/Lotto”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi may cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Contact your doctor immediately or seek immediate medical help if, during treatment with Skyrizi, you notice any signs of an allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion
• severe itching, with red rash or raised bumps on the skin

Children and adolescents
Skyrizi is not recommended in children and adolescents under 18 years of age, as Skyrizi has not been studied in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist, or nurse:

• if you are currently taking, have recently taken, or might need to take any other medicines.
• if you have recently received or are due to receive any vaccination. You must not receive certain types of vaccines while using Skyrizi.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during treatment with Skyrizi.

Pregnancy, contraception, and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine, as it is not known whether this medicine could harm the unborn baby.
If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with this medicine and for at least 21 weeks after the last dose of Skyrizi.
If you are breastfeeding or intend to breastfeed, ask your doctor for advice before using this medicine.

Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive vehicles or operate machinery.

Skyrizi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e. essentially "sodium-free".

3. How to use Skyrizi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is administered via a single injection under the skin (subcutaneous injection).
How much Skyrizi to use
Each dose is 150 mg, to be administered as a single injection. After the first dose, you will receive
the next dose 4 weeks later, and then every 12 weeks thereafter.
You may, together with your doctor, pharmacist or nurse, decide to self-administer this
medicine. Do not self-administer this medicine until you have received instructions from your doctor,
pharmacist or nurse.
An injection may also be given by someone caring for you, after they have been trained.
Before injecting Skyrizi, carefully read section 7 “Instructions for use”, at the end of
this leaflet.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should, or if the dose was administered earlier than prescribed,
inform your doctor.
If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, consult your
doctor.
If you stop using Skyrizi
Do not stop using Skyrizi without first talking to your doctor. If you stop treatment, your
symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Allergic reactions – these may require urgent treatment. Immediately contact your
doctor or seek immediate medical help if you experience any of the following symptoms:
Severe allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000 people). Symptoms include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• low blood pressure, which may cause dizziness or mild confusion

Immediately contact your doctor or seek immediate medical help if any of the
following symptoms occur.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• tiredness or shortness of breath, persistent cough
• skin that is warm, red and painful, or painful rash with blistering

Your doctor will decide whether you can continue using Skyrizi.
Other side effects
Tell your doctor, pharmacist or nurse if you experience any of the following side effects
Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

Common: may affect up to 1 in 10 people

• feeling tired
• fungal skin infections
• 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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skyrizi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the syringe label and on the carton after 'EXP/Exp'.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
If necessary, the pre-filled syringe may also be stored outside the refrigerator (up to 25 °C) for a maximum of 24 hours in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the solution is cloudy or contains flakes or large particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Skyrizi contains

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

Description of the appearance of Skyrizi and contents of the pack
Skyrizi is a clear, colourless to yellow liquid, available in a pre-filled syringe with a needle safety device. The liquid may contain small white or transparent particles.
Each pack contains 1 pre-filled syringe.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel: +36 1 455 8600

Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 22983201

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 91 384 09 10 Tel: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
More detailed and up-to-date information on this medicine is available by scanning the QR code shown below or on the outer packaging with a smartphone. The same information is also available at the following URL:
www.skyrizi.eu
QR code to be included

To listen to or request a copy of this package leaflet in , , or , please contact the local representative of the Marketing Authorisation Holder.

7. Instructions for Use

Read all of section 7 before using Skyrizi
Skyrizi pre-filled syringe
Plunger Flange Needle cap

Syringe barrel
Important information to know before injecting Skyrizi

• You must receive training on how to inject Skyrizi before administering the injection. If you need help, consult your doctor, pharmacist, or nurse.
• Mark the dates on your calendar so you know when to inject Skyrizi.
• Keep Skyrizi in its original packaging to protect the medicine from light until ready to use.
• Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should be clear to yellow and may contain small white or transparent particles.
• Do not shake the syringe.
• Wait to remove the needle cap until just before injection.

Return this medicine to the pharmacy if:

• After the expiry date (Exp.)
• If the liquid has been frozen (even after thawing)
• If the syringe has been dropped or is damaged
• If the packaging seals are damaged

For a more comfortable injection: Remove the syringe from the refrigerator and allow it to reach room temperature, protected from direct sunlight, for 15–30 minutes before injecting.

• Skyrizi must not be heated in any other way (e.g., in a microwave or warm water).
• Keep the syringe in its carton until ready for injection.

Follow these instructions every time you use Skyrizi
STEP 1 Remove the pre-filled syringe from the
carton by holding it at the flange.

Do not grasp or pull the plunger when
removing the pre-filled syringe
from the carton.
Place the following items on a clean, flat surface:
1 pre-filled syringe
1 alcohol swab (not included in the package)
1 cotton ball or gauze pad (not included in the package)
sharps disposal container (not included in the package)
Wash and dry your hands.
STEP 2 Choose one of these three injection sites:
left thigh (front area)
Injection sites
right thigh (front area)
abdomen (belly), at least 5 cm
away from the navel

Before injection, clean the selected area with a circular motion using an alcohol swab.
Do not touch or blow on the injection site after cleaning. Allow the skin to dry before injecting.
Do not inject through clothing.
Do not inject into irritated, bruised, red, hardened, scarred, or stretch-marked skin.
Do not inject into areas affected by psoriasis.
Injection sites
STEP 3 Hold the syringe with the needle pointing downward, as shown.

Check the liquid in the syringe.
It is normal to see bubbles in the viewing window.
The liquid should be clear to yellow and may contain small white or transparent particles.
Do not use if the liquid is cloudy or contains flakes or large particles.
L
Check the liquid
STEP 4 Remove the needle cap:
Hold the syringe in one hand between the flange

and the needle cap.
With the other hand, gently pull the needle cap straight off.
Do not hold or pull the plunger when removing the needle cap.
A drop of liquid may be visible at the tip of the needle. This is normal.
Discard the needle cap.
Do not touch the needle with your fingers or touch anything with the needle.
STEP 5 Hold the syringe barrel between your thumb and index finger of one hand, like a pencil.

With the other hand, gently pinch and firmly hold a fold of cleaned skin.
Insert the needle completely into the skin at an angle of about 45 degrees with a quick, firm motion. Keep the syringe at the same angle throughout.
STEP 6 Slowly and completely push the plunger down until all the liquid is injected.
Ts1

Remove the needle from the skin, keeping the syringe at the same angle.
Slowly release your thumb from the plunger.
The needle shield will then cover the needle.
The needle shield will not activate until all the liquid has been injected.
If you think you did not inject the full dose, consult your doctor, pharmacist, or nurse.
Needle shield
Press a cotton ball or gauze pad onto the injection site and hold for 10 seconds.
Do not rub the injection site. Mild bleeding at the injection site may occur. This is normal.
STEP 7
Dispose of the used syringe immediately in a sharps disposal container.

Do not dispose of the used syringe in household waste.
Your doctor, pharmacist, or nurse will explain how to return the sharps disposal container once it is full.

Patient information leaflet

Skyrizi 75 mg solution for injection in pre-filled syringe

risankizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Skyrizi is and what it is used for
2. What you need to know before using 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

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis

How Skyrizi works
This medicine works by blocking 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 the 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 joint inflammation and psoriasis. If you have active psoriatic arthritis, you may initially be given other medicines. If these medicines are not sufficiently effective, you will be given Skyrizi alone or in combination with other medicines for the treatment of psoriatic arthritis.
Skyrizi reduces inflammation and can therefore help reduce pain, stiffness, and swelling in and around the joints, pain and stiffness of the spine, psoriatic skin rash, psoriatic nail damage, and can slow down damage to the bones and cartilage of the joints. These effects may make everyday activities easier, reduce fatigue, and improve quality of life.

2. What you should know before using Skyrizi

Do not use Skyrizi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi:

• if you currently have an infection or if you have an infection that keeps recurring.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You must not receive certain types of vaccines while using Skyrizi.

It is important to record the batch number of your Skyrizi package.
Each time you receive a new Skyrizi package, write down the date and the batch number (found on the package after “Lot/Lotto”) and keep this information in a safe place.

Severe allergic reactions
Skyrizi can cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Contact your doctor immediately or seek immediate medical help if, during treatment with Skyrizi, you notice any signs of an allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion
• severe itching of the skin, with red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age, as Skyrizi has not been studied in this age group.

Other medicines and Skyrizi
Inform your doctor, pharmacist, or nurse:

• if you are taking, have recently taken, or might take any other medicines.
• if you have recently received or are due to receive any vaccination. You must not receive certain types of vaccines while using Skyrizi.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during treatment with Skyrizi.

Pregnancy, contraception, and breastfeeding
If you are pregnant, think you might be pregnant, or are planning a pregnancy, consult your doctor before using this medicine, as it is not known whether this medicine could harm the unborn baby.
Women of childbearing potential must use an effective method of contraception during treatment with this medicine and for at least 21 weeks after the last dose of Skyrizi.
If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.

Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive or operate machinery.

Skyrizi contains sorbitol and sodium
This medicine contains 68 mg of sorbitol per 150 mg dose.
This medicine contains less than 1 mmol (23 mg) of sodium per 150 mg dose, i.e., essentially "sodium-free".

3. How to use Skyrizi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is administered as 2 subcutaneous injections (subcutaneous injections).
How much Skyrizi to use
The dose is 150 mg, administered as two injections of 75 mg each.

You may decide, together with your doctor, pharmacist, or nurse, to self-administer this medicine, but only if they provide you with instructions on how to inject the medicine. Caregivers may also administer the injections after being trained.
Before injecting yourself with Skyrizi, carefully read section 7 “Instructions for use” at the end of
this package leaflet.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should, or if the dose was administered earlier than prescribed, inform your doctor.
If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, consult your doctor.
If you stop using Skyrizi
Do not stop using Skyrizi without first talking to your doctor. If you stop treatment, symptoms may return.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Allergic reactions – these may require urgent treatment. Immediately inform your doctor or seek immediate medical help if any of the following symptoms occur:
Severe allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000 people). Symptoms include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• low blood pressure, which may cause dizziness or mild confusion

Immediately inform your doctor or seek immediate medical help if any of the following symptoms occur.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• tiredness or shortness of breath, persistent cough
• skin that is warm, red, painful, or a painful rash with blistering

Your doctor will decide whether you can continue using Skyrizi.
Other side effects
Tell your doctor, pharmacist or nurse if any of the following side effects occur.
Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• small raised red spots on the skin
• hives

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skyrizi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the syringe label and on the carton after 'EXP/Scad.'.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringes in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that the liquid is cloudy or contains flakes or large particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Skyrizi contains

• The active substance is risankizumab. Each pre-filled syringe contains 75 mg of risankizumab in 0.83 mL of solution.
• The other components are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections.

Description of the appearance of Skyrizi and contents of the pack
Skyrizi is a clear, colourless to slightly yellow liquid, available in a pre-filled syringe with a needle shield. The liquid may contain small white or transparent particles.
Each pack contains 2 pre-filled syringes and 2 alcohol swabs.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy

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

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел:+359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel:+36 1 455 8600

Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 22983201

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. Z o.o.
Tel: +34 91 384 09 10 Tel: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: + 385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
More detailed and up-to-date information on this medicinal product is available by scanning the QR code below or on the outer packaging with a smartphone. The same information is also available at the following URL:
www.skyrizi.eu
QR code to be included

To listen to or request a copy of this package leaflet in , , or , please contact the local representative of the Marketing Authorisation Holder.

7. Instructions for Use

Read all of section 7 before using Skyrizi
Plunger Flange Needle cap

Syringe barrel
Important information to know before injecting Skyrizi

• You must receive training on how to inject Skyrizi before administering the injection. If you need help, consult your doctor, pharmacist, or nurse.
• Mark the dates on your calendar so you know when to inject Skyrizi.
• Keep Skyrizi in its original packaging to protect the medicine from light until it is ready to be used.
• Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should be clear or slightly yellow and may contain small white or transparent particles.
• Do not shake the syringe.
• Wait to remove the needle cap until shortly before injection.

Return this medicine to the pharmacy

• after the expiry date (Exp.)
• if the liquid has been frozen (even after thawing)
• if the syringe has been dropped or damaged
• if the paper seal on the syringe tray is broken or missing

For a more comfortable injection: Remove the package from the refrigerator and allow it to reach room temperature, protected from direct sunlight, for 15–30 minutes before injecting.

• Skyrizi must not be heated in any other way (e.g., in a microwave or in warm water).
• Keep the syringes in their case until you are ready for injection.

Follow these instructions every time you use Skyrizi
STEP 1 Place the following items on a clean, flat surface:
2 pre-filled syringes and 2 alcohol swabs

(included in the package)
2 cotton balls or gauze pads
(not included in the package)
Sharps disposal container (not included in the package)
Wash and dry your hands.
Begin with one syringe for the first injection.
A complete dose requires 2 injections, one after the other.
STEP 2 Choose one of these three injection sites:
front of the left thigh
Injection sites
front of the right thigh
abdomen (belly), at least 5 cm

from the navel
For the second syringe, inject at least 3 cm away from the first injection site. Do not inject into the same spot.
Before each injection, clean the chosen area with a circular motion using an alcohol swab.
Do not touch or blow on the injection site after cleaning. Allow the skin to dry before injecting.
Do not inject through clothing.
Do not inject into irritated skin, bruised, red, hardened, scarred, or stretch-marked skin.
Injection sites
Do not inject into areas affected by psoriasis.
STEP 3 Hold the syringe with the needle cap pointing downward, as shown.

Check the liquid in the syringe.
It is normal to see bubbles in the viewing window.
The liquid should be clear or slightly yellow and may contain small white or transparent particles.
Do not use it if the liquid is cloudy or contains flakes or large particles.
Check the liquid
STEP 4 Remove the needle cap:

Hold the syringe in one hand between the flange and the needle cap.
With the other hand, gently pull the needle cap straight off.
Do not hold or pull the plunger when removing the needle cap.
You may see a drop of liquid at the tip of the needle. This is normal.
Discard the needle cap.
Do not touch the needle with your fingers or touch anything with the needle.
STEP 5 Hold the syringe barrel with one hand between your thumb and index finger, as if holding a pencil.

With the other hand, gently pinch and firmly hold a fold of cleaned skin.
Insert the needle completely into the skin at an angle of approximately 45 degrees with a quick, firm motion. Keep the syringe at the same angle throughout.
STEP 6 Push the plunger slowly and completely until all the liquid is injected.

Remove the needle from the skin, keeping the syringe at the same angle.
Slowly lift your thumb from the plunger.
The needle safety guard will then cover the needle.
The needle safety guard will not activate until all the liquid has been injected.
If you think you did not inject the full dose, consult your doctor, pharmacist, or
Needle safety guard nurse.
Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.
Do not rub the injection site. Mild bleeding at the injection site may occur. This is normal.
STEP 7
A complete dose requires 2 injections, one after the other.

Repeat steps 2 to 6 with the second syringe.
Inject the contents of the second syringe immediately after the first injection, but at least 3 cm away from the first injection site.
2 injections are required
STEP 8 Dispose of used syringes immediately into a sharps disposal container.

Do not dispose of used syringes in household waste.
Your doctor, pharmacist, or nurse will explain how to return the sharps container once it is full.

Package leaflet: Information for the patient

Skyrizi 600 mg concentrate for solution for infusion

risankizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat adult patients with:
moderate to severe Crohn’s disease
moderate to severe ulcerative colitis

How Skyrizi works
This medicine works by blocking a protein in the body called "IL-23", which causes inflammation.

Crohn’s disease
Crohn’s disease is an inflammatory condition affecting the gastrointestinal tract. If you have active Crohn’s disease, you will initially be given other medicines. If these medicines are not sufficiently effective, Skyrizi will be given to treat your Crohn’s disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine. If you have active ulcerative colitis, you will initially be given other medicines. If these medicines are not sufficiently effective or if you cannot take them, Skyrizi will be given to treat your ulcerative colitis.

Skyrizi reduces inflammation and can therefore help relieve the signs and symptoms of the disease.

2. What you need to know before receiving Skyrizi

Do not receive Skyrizi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi:

• if you currently have an infection or if you have an infection that keeps recurring.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You must not receive certain types of vaccines while using Skyrizi.

It is important that your doctor or nurse records the batch number of the Skyrizi pack.
Each time you receive a new pack of Skyrizi, your doctor or nurse must record the date and
the batch number (found on the pack after “Batch”).

Severe allergic reactions
Skyrizi can cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Immediately inform your doctor or seek immediate medical help if, during treatment with Skyrizi, you notice any signs of an allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion
• severe itching of the skin, with red rash or raised bumps

Children and adolescents
Skyrizi is not recommended in children and adolescents under 18 years of age, as the use of Skyrizi has not been approved in this age group.

Other medicines and Skyrizi
Inform your doctor, pharmacist, or nurse:

• if you are currently using, have recently used, or might use any other medicines.
• if you have recently received or are due to receive a vaccination. You must not receive certain types of vaccines while using Skyrizi.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during treatment with Skyrizi.

Pregnancy, contraception, and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor for advice before using this medicine. This is because it is not known whether this medicine could harm the unborn baby.
If you are a woman of childbearing age, you should use an effective method of contraception during treatment with this medicine and for at least 21 weeks after the last dose of Skyrizi.
If you are breastfeeding or intend to breastfeed, ask your doctor for advice before using this medicine.

Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive or operate machinery.

Skyrizi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How Skyrizi is administered

Treatment with Skyrizi will start with an initial dose, which will be administered to you by a doctor or
nurse through an intravenous infusion into your arm (intravenous infusion).
Initial doses

Subsequently, Skyrizi will be administered to you as a subcutaneous injection. Please consult the package leaflet of Skyrizi 90 mg in pre-filled syringe, 180 mg and 360 mg solution for injection in cartridge.
Maintenance doses

If you forget to use Skyrizi
If you forget or miss an appointment for administration of one of the doses, contact your doctor as soon as you remember to reschedule the appointment.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Allergic reactions – these may require urgent treatment. Immediately inform your
doctor or seek immediate medical attention if any of the following symptoms occur:
Severe allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000 people). Symptoms include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• low blood pressure, which may cause dizziness or mild confusion

Immediately inform your doctor or seek immediate medical attention if any of the
following symptoms occur.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, persistent cough
• skin that is warm, red and painful, or a painful rash with blistering

Your doctor will decide whether you can continue using Skyrizi.
Other side effects
Inform your doctor, pharmacist or nurse if any of the following side effects occur.
Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

Common: may affect up to 1 in 10 people

• feeling of fatigue
• 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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skyrizi

Skyrizi 600 mg concentrate for solution for infusion is administered in a hospital or clinic setting and
it is not the patient's responsibility to store or handle it.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after "Exp.".
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Do not shake the Skyrizi vial. Shaking the vial vigorously and for prolonged periods may damage the
medicine.
Do not use this medicine if you notice that the liquid is cloudy or contains flakes or large particles.
Each vial is for single use only.
Do not dispose of any medicine via wastewater or household waste. This will help protect the
environment.

6. Package contents and other information

What Skyrizi contains

• The active substance is risankizumab. Each vial contains 600 mg of risankizumab in 10 mL of solution.
• The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.

Description of the appearance of Skyrizi and contents of the pack
Skyrizi is a clear, colourless to slightly yellow liquid, available in a vial. The liquid may contain small white or transparent particles.
Each pack contains 1 vial.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy
EL -
or
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel: +36 1 455 8600

Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 22983201

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 91 384 09 10 Tel: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
More detailed and up-to-date information on this medicine is available by scanning the QR code shown below or on the outer packaging with a smartphone. The same information is also available at the following URL: www.skyrizi.eu

[QR code to be included]

To listen to or request a copy of this package leaflet in , or , please contact the local representative of the Marketing Authorisation Holder.

The following information is intended exclusively for healthcare professionals:

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly documented.
Instructions for use

1. This medicinal product must be prepared by a qualified healthcare professional using an aseptic technique.
2. It must be diluted before administration.
3. The infusion solution is prepared by diluting the concentrate in an infusion bag or glass vial containing 5% dextrose in water (D5W) or 9 mg/mL (0.9%) sodium chloride infusion solution, to a final concentration between approximately 1.2 mg/mL and 6 mg/mL. For dilution instructions based on the patient's indication, refer to the table below.

4. The solution in the vial and the diluted solution must not be shaken.
5. Before starting intravenous infusion, the contents of the infusion bag or glass vial must be at room temperature.
6. Infuse the diluted solution over at least one hour for the 600 mg dose and over at least two hours for the 1,200 mg dose.
7. The solution in the vial must not be administered concomitantly with other medicinal products in the same infusion line. Each vial is for single use only. Unused medicinal product and waste material must be disposed of in accordance with local regulations.

Storage of the diluted solution
Chemical and physical in-use stability has been demonstrated for 20 hours at a temperature between 2°C and 8°C (protected from light) or up to 4 hours (cumulative time from the start of dilution to the start of infusion) at room temperature (protected from light). Exposure to indoor light is acceptable during storage at room temperature and during administration.
From a microbiological standpoint, the prepared infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 20 hours at a temperature of 2°C–8°C. Do not freeze.

Patient information leaflet

Skyrizi 180 mg solution for injection in pre-filled pen, 360 mg solution for injection in pre-filled pen

risankizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Skyrizi is and what it is used for
2. What you need to know before using 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

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat adult patients with:

• moderate to severe Crohn’s disease
• moderate to severe ulcerative colitis

How Skyrizi works
This medicine works by blocking a protein in the body called “IL-23”, which causes inflammation.
Crohn’s disease
Crohn’s disease is an inflammatory disease of the gastrointestinal tract. If you have active Crohn’s disease, you will initially be given other medicines. If these medicines are not sufficiently effective, Skyrizi will be given to treat your Crohn’s disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine. If you have active ulcerative colitis, you will initially be given other medicines. If these medicines are not sufficiently effective or if you cannot take these medicines, Skyrizi will be given to treat your ulcerative colitis.
Skyrizi reduces inflammation and can therefore help relieve the signs and symptoms of the disease.

2. What you need to know before using Skyrizi

Do not use Skyrizi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi:

• if you currently have an infection or if you have an infection that keeps recurring.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You must not receive certain types of vaccines while using Skyrizi.

It is important to record the batch number of your Skyrizi pack.
Each time you receive a new pack of Skyrizi, write down the date and the batch number (found on the pack after “Batch”) and keep this information in a safe place.

Severe allergic reactions
Skyrizi may cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Immediately inform your doctor or seek immediate medical help if, during treatment with Skyrizi, you notice any signs of an allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion
• severe itching, with red rash or raised bumps on the skin

Children and adolescents
Skyrizi is not recommended in children and adolescents under 18 years of age, as the use of Skyrizi has not been approved in this age group.

Other medicines and Skyrizi
Inform your doctor, pharmacist, or nurse:

• if you are currently taking, have recently taken, or might take any other medicines.
• if you have recently received or are due to receive any vaccination. You must not receive certain types of vaccines while using Skyrizi.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during treatment with Skyrizi.

Pregnancy, contraception, and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine, because it is unknown whether this medicine could harm the unborn baby.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with this medicine and for at least 21 weeks after the last dose of Skyrizi.
If you are breastfeeding or planning to breastfeed, ask your doctor for advice before using this medicine.

Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive or operate machinery.

Skyrizi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per cartridge, i.e., essentially ‘sodium-free’.

3. How to use Skyrizi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is administered by injection under the skin (subcutaneous injection).
How much Skyrizi to use
Treatment with Skyrizi will start with an initial dose, which will be administered to you by a doctor or
nurse via a drip into your arm (intravenous infusion).
Initial doses

Subsequently, Skyrizi will be administered to you as a subcutaneous injection.
Maintenance doses

You may decide, together with your doctor, pharmacist, or nurse, to self-administer this
medicinal product. Do not self-administer this medicinal product before receiving instructions from your doctor,
pharmacist, or nurse. A caregiver may also administer the injection after being properly trained.
Before injecting yourself with Skyrizi, carefully read section 7 “Instructions for use” at the end of
this leaflet.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should, or if the dose was administered earlier than prescribed,
inform your doctor.
If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, consult your
doctor.
If you stop using Skyrizi
Do not stop using Skyrizi without first talking to your doctor. If you stop treatment, your
symptoms may return.
If you have any questions about the use of this medicinal product, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Allergic reactions – these may require urgent treatment. Immediately inform your
doctor or seek immediate medical help if any of the following symptoms occur:
Severe allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000 people). Symptoms include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• low blood pressure, which may cause dizziness or mild confusion

Immediately inform your doctor or seek immediate medical help if any of the
following symptoms occur.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• tiredness or shortness of breath, persistent cough
• skin that is warm, red and painful, or painful rash with blistering

Your doctor will decide whether you can continue using Skyrizi.
Other side effects
Tell your doctor, pharmacist or nurse if you experience any of the following side effects.
Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skyrizi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after “Exp.”.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, the cartridge may be stored outside the refrigerator (up to 25 °C) for a maximum period of 24 hours.
Keep the cartridge in its original packaging to protect the medicine from light.
Do not use this medicine if you notice that the liquid is cloudy or contains flakes or large particles.
Each on-body injector with cartridge is for single use only.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Skyrizi contains
The active substance is risankizumab.
Skyrizi 180 mg solution for injection in cartridge

• Each cartridge contains 180 mg of risankizumab in 1.2 mL of solution.
• The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.

Skyrizi 360 mg solution for injection in cartridge

• Each cartridge contains 360 mg of risankizumab in 2.4 mL of solution.
• The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.

Description of the appearance of Skyrizi and contents of the pack
Skyrizi is a clear, colourless to yellow liquid in a cartridge. The liquid may contain small white or transparent particles.
Each pack contains 1 cartridge and 1 on-body injector.

Marketing Authorisation Holder and Manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

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

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel: +36 1 455 8600

Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 22983201

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 91 384 09 10 Tel: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
More detailed and up-to-date information on this medicinal product is available by scanning the QR code below or on the outer packaging with a smartphone. The same information is also available at the following URL: www.skyrizi.eu
QR code to be included

To listen to or request a copy of this patient information leaflet in , , or , please contact the local representative of the Marketing Authorisation Holder.

7. Instructions for Use

Read the entire section 7 before using Skyrizi
Skyrizi on-body injector
Front view
Status light Start button
Adhesive material Do not press until you
are ready for injection

Grey lid Medicinal product window Tabs
Do not close the grey lid
without the cartridge
inside
Back view
Plastic strip Needle cap Adhesive pad
transparent

Caution. Needle inside
(under the needle cap)
Do not touch the needle cap area or the needle
Green tab Green tab
small section large section
Side view

Lid latch
The opening side has grooves
The grey lid must be
slightly open
Do not close the grey lid
without the cartridge
inside
Needle cap
Needle inside (under the
needle cap)
Do not touch the needle cap
area or the needle
Cartridge

Larger top part of
the cartridge
The white plunger expands
towards the bottom of the
cartridge as the medicine
is injected. Expiry date (Exp.)
F-
Located on the cartridge label
Medicine
Smaller lower tip
Important information to know before injecting Skyrizi

• You must receive training on how to inject Skyrizi before administering the injection. If you need help, consult your doctor, pharmacist, or nurse
• Mark the dates on your calendar so you know when to inject Skyrizi
• The single-use on-body injector is designed exclusively for use with the Skyrizi cartridge
• Keep Skyrizi in its original packaging to protect the medicine from light until ready to use
• Remove the package from the refrigerator and allow it to reach room temperature, protected from direct sunlight, for at least 45 and up to 90 minutes before administering the injection
• Do not wet the on-body injector with water or other liquids
• Do not touch the start button until you have placed the cartridge-loaded on-body injector on your skin and are ready for injection

o The start button can only be pressed once

• Physical activity should be limited during the injection procedure. Moderate activity such as walking, stretching, and bending is allowed
• Do not delay the injection after loading the clean cartridge into the on-body injector. Waiting may cause the medicine to dry out and the on-body injector to fail
• Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should be clear to yellow and may contain small white or transparent particles
• Do not shake the box, cartridge, or on-body injector
• Do not reuse the cartridge or on-body injector

Return this medicine to the pharmacy

• after the expiry date (Exp.)
• if the liquid has been frozen (even after thawing)
• if the cartridge or on-body injector has fallen or is damaged
• if the packaging seals are damaged
• if the white paper cover of the tray is broken or missing

Follow these instructions every time you use Skyrizi
STEP 1 - Preparation

Remove the package from the refrigerator and let it
reach room temperature, protected from direct
sunlight, for at least 45 and up to 90 minutes before
administering the injection.

• Check the expiry date (Exp.) on the packaging. Do not use Skyrizi after the expiry date (Exp.).

• Do not remove the cartridge or on-body injector from the packaging until Skyrizi has
  reached room temperature
  1 B

• Do not heat Skyrizi in any other way. For example, do not heat Skyrizi in a microwave or warm water

Sharps container Gather all materials 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 swabs (not included in the package)
• 1 cotton ball or gauze pad (not included in the package)
• sharps container (not included in the package)

Wash and dry your hands.

Remove the white paper seal from the tray

• Locate the white arrow
• Peel off the white paper seal from the plastic tray

Lift the plastic lid

• Locate the rounded opening on the top lid
• Insert your index finger into the opening and place your thumb on the opposite side
• Lift the lid to remove it and keep it aside

Inspect the on-body injector

• Check that the on-body injector is intact and undamaged
• The grey lid must be slightly open Lid • If the grey lid does not open, press firmly on the grooves (left side of the lid) and open the lid
• Do not close the grey lid before the cartridge is loaded Start button
• Do not use the on-body injector if it has fallen, is missing parts, or is damaged
• Do not touch the start button until the time of injection. It can only be pressed once
• Do not touch the needle cap area or the needle

The on-body injector can no longer be used if the
start button is pressed before placing it on the body.
In this case, consult your doctor, pharmacist, or nurse.
Needle inside
(under the needle cap)
STEP 2 - Preparing the on-body injector
Grey lid Open the grey lid fully

• Avoid touching the needle cap area or the back

El of the on-body injector. The needle is behind the
needle cap

• Rotate the grey lid fully to the right to open it
• If the grey lid does not open, press firmly on the grooves (left side of the lid) and open the lid
• Do not close the grey lid before the cartridge is loaded

Set the on-body injector aside.
Back view
Needle inside
(under the
needle cap)
Needle cap
Larger top part of the cartridge Inspect the cartridge

Carefully remove the cartridge from the plastic tray.

• Do not rotate or remove the top part of the cartridge

Check the cartridge

• The liquid should be clear to yellow and may contain small white or transparent particles. It is normal to see one or more bubbles
• Do not use the cartridge if the liquid is cloudy or contains flakes or large particles
• Verify that the cartridge parts and transparent plastic are not cracked or broken
• Do not use the cartridge if the liquid has been frozen (even after thawing)
• Do not use the cartridge if it has fallen, is missing parts, or is damaged. Smaller lower tip

Clean the smaller lower tip of the cartridge
Locate the smaller lower tip of the cartridge

• Clean the smaller lower tip of the cartridge with an alcohol swab. Use the alcohol swab to clean the center of the smaller lower tip of the cartridge
• Do not touch the smaller lower tip of the cartridge after cleaning

,
Smaller lower tip
Clean the center of the
smaller lower tip
Insert vertically Load the clean cartridge into the on-body injector
“click” • Do not rotate or remove the top part of the

2D cartridge

• First, insert the smaller lower tip of the cartridge into the on-body injector
• Firmly push the larger top part of the cartridge downward until you hear a “click”
• After loading the cartridge, you may notice some drops of medicine on the back of the on-body injector. This is normal

Proceed immediately to the next step. Waiting may
cause the medicine to dry out.
Close the grey lid
Rotate the grey lid to the left, then press firmly and wait
for it to snap shut

• The grey lid must remain locked once the cartridge is loaded
• Do not close the grey lid if the cartridge is not fully inserted or is missing
• Proceed immediately to the next step

/--
“snap”
STEP 3 - Preparation for injection
Select and clean the injection site
Injection sites Choose one of these three injection sites:

• front of the left thigh
• front of the right thigh
• abdomen (stomach), at least 5 cm from the navel

Do not inject into areas of skin with natural folds
or bumps, as the on-body injector may fall off during use.
Before injection, clean the selected area with a circular
motion using an alcohol swab.

• Do not touch or blow on the injection site after cleaning. Let the skin dry before placing the on-body injector on the skin
• Do not inject through clothing
• Do not inject into irritated, bruised, red, hardened, scarred, or stretch-marked skin, moles, or areas with excessive hair. You may trim excessive hair at the injection site

Small section Large section Remove both tabs to expose the skin adhesive

3B Turn the on-body injector to find the two green tabs

• Avoid touching the needle cap (needle inside)

Remove the large section using the green tab to expose
the skin adhesive
Remove the small section using the green tab to expose
the skin adhesive. This removes the transparent plastic
strip, activating the on-body injector

• Check the status light when the on-body injector emits an audible signal Needle inside
  (under the needle cap)
• The status light flashes blue when the on-body injector is activated
• If the status light does not flash blue, consult your doctor, pharmacist, or nurse
• Do not press the grey start button yet Activated • Do not touch the needle cap or the needle injector • Do not peel the adhesive material off the on-body Status light injector and avoid the adhesive side folding over itself or sticking to itself flashing blue
  The Skyrizi on-body injector must be placed on the skin and the injection must start within 30 minutes after removing the green tabs, otherwise the injector will not work. Proceed immediately to the next step.

,
o P

If the status light flashes red,
the on-body injector is not working properly.
Do not continue using it.
Consult your doctor, pharmacist, or nurse for
assistance.
If the on-body injector is applied to the body, remove
it carefully from the skin.

Prepare the on-body injector for placement

• For the abdomen (stomach), stretch the skin to create a stable, flat surface for injection, at least 5 cm from the navel. Ensure you are sitting upright to avoid skin folds and bumps.
• For the front of the left or right thigh, stretching the skin is not necessary.

Position the on-body injector so that you can see the
blue status light.
Place the on-body injector on the skin

• When the blue status light is flashing, the on-body
  injector is ready. Place the on-body injector on the
  clean skin with the status light visible

• Do not place the on-body injector on clothing, only on bare skin.

• Run your finger around the adhesive material to secure it

• Do not move or adjust the on-body injector once placed on the skin

Proceed immediately to the next step.
STEP 4 - Injecting Skyrizi

Start the injection
Firmly press and release the grey start button

• You will hear a “click” and may feel the needle prick
• Check the status light when the on-body injector emits an audible signal
• After starting the injection, the status light flashes continuously green
• After starting the injection, you will hear pumping-like sounds as the on-body injector delivers the medicine

Do not continue using the on-body injector if the
status light flashes red. Carefully remove it from the
skin if the status light flashes red. In this case, consult
your doctor, pharmacist, or nurse.

Wait for the injection to complete
4B

• Delivery of the full dose of medicine may take up to 5 minutes. The on-body injector stops automatically when the injection is complete
• During the injection, the status light continues to flash green
• During the injection, you will hear pulsing sounds as the on-body injector continues to deliver the medicine
• Moderate physical activity such as walking, stretching, and bending is allowed during the injection

Do not continue using the on-body injector if the
status light flashes red. Carefully remove it from the
skin if the status light flashes red. In this case, consult
your doctor, pharmacist, or nurse.
,
The injection is complete when:
4C

• The on-body injector stops by itself
• You hear an audible signal and the status light turns solid green. If the status light is solid green, this means the injection is complete

Remove the on-body injector

• Do not place your fingers on the back of the on-body injector when removing it from the skin
• At the end of the injection, grasp the edge of the adhesive to carefully peel the on-body injector off the skin
• Avoid touching the needle cap or the needle on the back of the on-body injector
• After removing the on-body injector, you will hear several audible signals and the status light will turn off
• The needle cap protects the needle when the on-body injector is removed from the skin
• It is normal to see small droplets of liquid on the skin after removing the on-body injector
• Press a cotton ball or gauze pad on the injection site and hold for 10 seconds
• Do not rub the injection site
• It is normal to have slight bleeding at the injection site

Proceed to the next step.
STEP 5 - Conclusion

Check the on-body injector
Inspect the medicine window and the status light.
Verify that the white plunger fills the entire medicine
window and that the solid green light turns off,
indicating that all the medicine has been injected.

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

Sharps container Disposal

Dispose of the used on-body injector in a sharps
container immediately after use.

• The on-body injector contains batteries, electronic components, and a needle.
• Leave the cartridge inside the on-body injector.
• Do not dispose of the used on-body injector in household waste.
• Your doctor, pharmacist, or nurse will explain how to return the sharps container once it is full. There may be local guidelines for disposal.

Patient information leaflet

Skyrizi 90 mg solution for injection in pre-filled syringe

risankizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat adult patients with moderately to severely active Crohn’s disease.
How Skyrizi works
This medicine works by blocking a protein in the body called "IL-23", which causes inflammation.
Crohn’s disease is an inflammatory condition of the gastrointestinal tract. If you have active Crohn’s disease, you will initially be treated with other medicines. If these medicines are not sufficiently effective, Skyrizi will be given to treat your Crohn’s disease.
Skyrizi reduces inflammation and can therefore help relieve the signs and symptoms of the disease.

2. What you need to know before receiving Skyrizi

Do not receive Skyrizi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi

• if you currently have an infection or if you have an infection that keeps recurring.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You must not receive certain types of vaccines while using Skyrizi.

It is important that your doctor or nurse records the batch number of the Skyrizi pack.
Each time you receive a new pack of Skyrizi, your doctor or nurse must record the date and
the batch number (found on the pack after “Lot/Lotto”).

Severe allergic reactions
Skyrizi can cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Immediately inform your doctor or seek immediate medical help if, during treatment with Skyrizi, you notice any signs of an allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion
• severe itching, with red rash or raised bumps on the skin

Children and adolescents
Skyrizi is not recommended in children and adolescents under 18 years of age, as the use of Skyrizi has not been approved in this age group.

Other medicines and Skyrizi
Inform your doctor, pharmacist, or nurse:

• if you are currently using, have recently used, or might use any other medicines.
• if you have recently received or are due to receive any vaccination. You must not receive certain types of vaccines while using Skyrizi.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during treatment with Skyrizi.

Pregnancy, contraception, and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor for advice before using this medicine, as it is not known whether this medicine could harm the unborn baby.
If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with this medicine and for at least 21 weeks after the last dose of Skyrizi.
If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.

Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive or operate machinery.

Skyrizi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 360 mg dose, i.e., essentially ‘sodium-free’.

Skyrizi contains sorbitol
This medicine contains 164 mg of sorbitol per 360 mg dose.

3. How Skyrizi is administered

Treatment with Skyrizi will begin with an initial dose, which will be administered to you by a doctor or
nurse via an intravenous infusion into your arm.
Initial doses

Subsequently, Skyrizi will be administered to you as an injection under the skin ("subcutaneous
injection"). The administration will be performed by your doctor or nurse as four separate
subcutaneous injections, as described below. Alternatively, Skyrizi can be administered using
an on-body injector.
Maintenance doses

If you forget to use Skyrizi
If you forget or miss an appointment for administration of one of the doses, contact your doctor as
soon as you remember to reschedule the appointment.
If you stop using Skyrizi
Do not stop using Skyrizi without first talking to your doctor. If you stop treatment, symptoms may
return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Allergic reactions – these may require urgent treatment. Immediately inform your doctor or seek immediate medical help if any of the following symptoms occur:
Severe allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000 people). Symptoms include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or mild confusion

Immediately inform your doctor or seek immediate medical help if any of the following symptoms occur.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, persistent cough
• skin that is warm, red, and painful, or a painful rash with blistering

Your doctor will decide whether you can continue using Skyrizi.
Other side effects
Tell your doctor, pharmacist, or nurse if you experience any of the following side effects.
Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

Common: may affect up to 1 in 10 people

• feeling tired
• fungal skin infections
• 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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skyrizi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the syringe and on the
carton after 'EXP/Scad.'.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringes in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that the liquid is cloudy or contains flakes or large
particles.
Each pre-filled syringe is for single use only.
Do not dispose of any medicine via wastewater or household waste. This will help protect
the environment.

6. Contents of the pack and other information

What Skyrizi contains

• The active substance is risankizumab. Each pre-filled syringe contains 90 mg of risankizumab in 1 mL of solution.
• The other components are disodium succinate hexahydrate, polysorbate 20, sorbitol, succinic acid and water for injections.

Description of the appearance of Skyrizi and contents of the pack
Skyrizi is a clear, colourless to slightly yellow liquid, available in a pre-filled syringe with a needle protection device. The liquid may contain small white or transparent particles.
Each pack contains 4 pre-filled syringes.
Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Manufacturer
AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023
България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811
Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel: +420 233 098 111 Tel: +36 1 455 8600
Danmark Malta
AbbVie A/S V.J.Salomone Pharma Limited
Tlf: +45 72 30-20-28 Tel: +356 22983201
Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel: 00800 222843 33 (free of charge) Tel: +31 (0)88 322 2843
Tel: +49 (0) 611 / 1720-0
Eesti Norge
AbbVie OÜ AbbVie AS
Tel: +372 623 1011 Tlf: +47 67 81 80 00
Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0
España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 91 384 09 10 Tel: +48 22 372 78 00
France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel: +351 (0)21 1908400
Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35
Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060
Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Tel: +354 535 7000 Tel: +421 2 5050 0777
Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600
Latvija
AbbVie SIA
Tel: +371 67605000

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
To listen to or request a copy of this summary of product characteristics in , , or , please contact the local representative of the Marketing Authorisation Holder.

The following information is intended exclusively for healthcare professionals:

Traceability
To improve the traceability of biological medicinal products, the name and batch number of the
administered medicinal product must be clearly recorded.
Skyrizi pre-filled syringe
Plunger Flange Needle cap

Syringe barrel
Instructions for use
This medicinal product must be administered by a healthcare professional.
Administer each pre-filled syringe subcutaneously as follows:
STEP 1 Before performing the injection, remove the
package from the refrigerator without removing the
pre-filled syringes from the packaging.

• Do not use this medicinal product if the

package seal is broken or missing, or if any component
is damaged.
Allow Skyrizi to reach room temperature, protected from direct sunlight
(for 15 to 30 minutes).
Do not shake the pre-filled syringes.
Prepare the following items on a flat, clean surface:

• 4 pre-filled syringes and 4 alcohol swabs (not included in the package)
• 4 cotton balls or gauze pads (not included in the package)
• Sharps disposal container (not included in the package)

Wash and dry your hands.
A complete dose requires 4 injections, one after the other.
STEP 2 Choose an injection site.
Injection sites

Inject one pre-filled syringe after another into the following anatomical areas:

• front of the left thigh or right thigh
• abdomen (belly), at least 5 cm from the navel

• Use a new site for each injection.
• For each syringe, inject at least Injection sites 3 cm away from the previous injection site. Do not inject into the same site.

Before each injection, clean the selected area with a circular motion using an alcohol swab.

• Do not inject into areas where the skin is tender, bruised, erythematous, thickened, or affected by lesions.

STEP 3 Hold the syringe with the needle cap pointing downward, as illustrated.

Inspect the liquid in the syringe.

• It is normal to see bubbles in the viewing window
• The liquid should be clear to yellow and may contain small white or transparent particles
• Do not use if the liquid is cloudy or contains flakes or large particles

Inspect the liquid
STEP 4 Remove the needle cap:

• Hold the syringe in one hand between the flange and the needle cap
• With the other hand, gently pull the needle cap straight off in a linear motion
• Do not hold or pull the plunger when removing the needle cap
• A drop of liquid may be visible at the tip of the needle. This is normal
• Discard the needle cap
• Do not touch the needle with fingers or touch anything with the needle

STEP 5 Hold the syringe barrel with one hand between the thumb and index finger, as if holding a

pencil.
With the other hand, gently lift and firmly hold a cleaned skin fold.
Insert the needle completely into the skin at an angle of approximately 45 degrees with a quick, decisive motion. Keep the syringe at the same angle throughout.
Slowly and completely push the plunger until all the liquid is injected.
Remove the needle from the skin while maintaining the syringe at the same angle.
Slowly lift the thumb from the plunger.
The needle will then be covered by the needle safety guard.
The needle safety guard will not activate until all the liquid has been injected.
Apply a cotton ball or gauze pad over the injection site and hold for 10 seconds.
STEP 6
Use four 90 mg pre-filled syringes to administer the maintenance dose of 360 mg

subcutaneously.

• Repeat steps 2 to 5 with the subsequent syringes.

If a dose is missed, administer it as soon as possible.
Then resume administration according to the established schedule.
A complete dose requires 4 injections
STEP 7 Each pre-filled syringe is intended for single use only, and any unused

medicinal product or waste material must be disposed of in accordance with local requirements.
ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS OF THE
MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for risankizumab, the scientific conclusions of the Committee for Human Medicinal Products (CHMP) are as follows:
In light of available data on anaphylaxis from spontaneous reports, including 6 cases occurring in close temporal association, the PRAC considers that a causal relationship between risankizumab and anaphylaxis is at least a reasonable possibility. The PRAC concluded that the product information for medicinal products containing risankizumab should be updated accordingly.
After reviewing the PRAC's recommendation, the CHMP agrees with the general conclusions and reasoning of the PRAC.
Reasons for the variation of the terms of the marketing authorisation
Based on the scientific conclusions regarding risankizumab, the CHMP considers that the benefit-risk balance of the medicinal product containing risankizumab remains favourable, subject to the proposed updates to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation.