SKYRIZI 75 mg Инъекционный Раствор

Содержание инструкции

1. Skyrizi 150 mg injectable solution in a pre-filled pen
   1. What is Skyrizi and what is it used for
   2. What you need to know before you use Skyrizi
   3. How to use Skyrizi
   4. Possible side effects
   5. How to store Skyrizi
   6. Contents of the pack and other information
   7. Instructions for Use
2. Skyrizi 150 mg injectable solution in pre-filled syringe
   1. What is Skyrizi and what it is used for
   2. What you need to know before you use Skyrizi
   3. How to use Skyrizi
   4. Possible side effects
   5. How to store Skyrizi
   6. Package contents and other information
   7. Instructions for Use
3. Skyrizi 75 mg injectable solution in pre-filled syringe
   1. What is Skyrizi and what is it 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
4. Skyrizi 600 mg concentrate for solution for infusion
   1. What is Skyrizi and what is it used for
   2. What you need to know before you receive Skyrizi
   3. How Skyrizi is administered
   4. Possible side effects
   5. How to store Skyrizi
   6. Package contents and other information
5. Skyrizi 180 mg injectable solution in cartridge, 360 mg injectable solution in cartridge
   1. What is Skyrizi 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
6. Skyrizi 90 mg injectable solution in pre-filled syringe
   1. What is Skyrizi and what it is used for
   2. What you need to know before you receive Skyrizi
   3. How Skyrizi is administered
   4. Possible side effects
   5. How to store Skyrizi
   6. Content of the pack and other information

Skyrizi 150 mg injectable solution in a pre-filled pen

risankizumab

Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you get any side effects, even 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 you use Skyrizi
• 3. How to use Skyrizi
• 4. Possible side effects
• 5. How to store Skyrizi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Skyrizi and what is it used for

Skyrizi contains the active ingredient 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 for the treatment of adults with moderate to severe plaque psoriasis. Skyrizi
reduces inflammation and can therefore help to reduce the symptoms of plaque psoriasis, such as burning,
itching, pain, redness and scaling.
Psoriatic arthritis
Skyrizi is used for the treatment of adults with psoriatic arthritis. Psoriatic arthritis is a disease
that causes inflammation of the joints 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 to reduce pain, stiffness and swelling in and around
the joints, pain and stiffness of the spine, psoriatic skin rash, psoriatic nail damage and may slow down damage to the bones and cartilage of the
joints. These effects can make normal daily activities easier, reduce fatigue and
improve quality of life.

2. What you need to know before you use Skyrizi

Do not use Skyrizi

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

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

• if you currently have an infection or if an infection keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You should not receive certain types of vaccines during the use of Skyrizi.

It is important to record the batch number of the Skyrizi pack.
Each time you receive a new pack of Skyrizi, write down the date and batch number (which can be found
on the pack after “Lot/Lotto”) and keep this information in a safe place.
Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor immediately or seek immediate medical help if you notice any signs of an allergic reaction during the
treatment with Skyrizi, such as:

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

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

Other medicines and Skyrizi
Tell 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 a vaccination. You should not receive certain types of vaccine during the use of Skyrizi.

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

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This is because it is not known whether this medicine can harm the
baby.
If you are a woman of childbearing potential, you should use effective contraception during the use of 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 and use machines.

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 following the instructions of your doctor or pharmacist exactly. 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 equal to 150 mg, to be administered with a single injection. After the first dose, you will receive
the next dose 4 weeks later and, subsequently, every 12 weeks.
You may decide together with your doctor, pharmacist or nurse to self-administer this
medicine. Do not self-administer this medicine before receiving instructions from your doctor,
pharmacist or nurse. Someone who cares for you can also perform the injection, after being
trained.

Before injecting Skyrizi, carefully read paragraph7 “Instructions for use”, at the end of
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or if the dose was administered to you before it was prescribed,
inform your doctor.

If you forget to use Skyrizi
If you have forgotten to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, contact
your doctor.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, the
symptoms may reappear.
If you have any doubts 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 medical treatment. Tell your doctor immediately or seek immediate medical attention if any of the following symptoms occur:
Serious allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000). Symptoms include:

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

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

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that does not go away
• warm, red, and painful skin, or painful rash with blisters

Your doctor will decide if you can continue to use Skyrizi.

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

Very common:may affect more than 1 in 10 people

• upper respiratory 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
• reactions at the injection site (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 get any side effects, 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 that is stated on the pen label and on the
pack after “EXP/Scad”.
Store in a 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, you can also store the pre-filled pen outside the refrigerator (up to 25 °C) for a
maximum period 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 any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. 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 pen 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 Skyrizi and contents of the pack
Skyrizi is a clear liquid, from colourless to yellow, 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, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
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

7. Instructions for Use

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

Grey grip points White needle protection sleeve
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
• Store Skyrizi in the original packaging to protect the medicine from light until the time of use
• Remove the package from the refrigerator and let it stand at room temperature, away from direct sunlight, for 30-90minutesbefore giving the injection.
• Do notinject 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 notshake the pen
• Wait to remove the dark grey cap until just before the injection

Return this medicine to the pharmacy

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

Follow these instructions every time you use Skyrizi
STEP 1Remove the package from the refrigerator and let it
stand at room temperature, away from
direct sunlight, for 30-90minutesbefore
giving the injection.

Do notremove the pen from the packaging until
Skyrizi has reached
room temperature

Do notheat Skyrizi in any other way.
For example, do notheat Skyrizi in the
microwave or in hot water.

Do notuse the pen if the liquid has been
frozen, even if it has been
subsequently thawed

STEP 2Place the following items on a clean, flat surface:

1 pre-filled pen
1 alcohol swab (not
included in the packaging)
1 cotton ball or gauze pad
(not included in the packaging)
special waste container (not included
in the packaging)
Wash and dry your hands.

STEP 3
Injection sites
Choose one of these three injection sites:
front of the left thigh
front of the right thigh
abdomen (belly), at least 5 cm

from the navel
Before the injection, rub the
chosen area with a circular motion with an
alcohol swab.

Do nottouch or blow on the injection site
after cleaning it. Let the skin dry before performing the injection

Do notinject through clothing

Do notinject on irritated, bruised,
reddened, hardened, scarred or
stretch-marked skin

Do notinject on areas affected by psoriasis

Injection sites
STEP 4
Check the liquid
Hold the pen with the dark grey cap
facing up, as shown.
Remove the dark grey cap

Dispose of 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 notuse it if the liquid is cloudy or
contains flakes or large
particles
U

STEP 5
Abdomen or thigh
Hold the pen with your fingers on the grey grip points.
Rotate the pen so that the white needle
protection sleeve is facing the injection site and the
green activator button is visible.
Gently grasp the skin
at the injection site and lift it firmly.
Position the white needle protection
sleeve against the raised injection site
(at a 90° angle).

STEP 6
First “click” 15 seconds
Hold the pen so that the
green activator button and the inspection window are visible.
Press and continue to hold the pen
against the raised injection site.

The pen will only activate if the white needle
protection sleeve is pressed
against the injection site before pressing
the green activator button
Press the green activator button and hold
the pen pressed for 15seconds.
~ A loud “click” indicates the start
of the injection

STEP 7
Second “click”
Continue to press the pen against the injection site.
The injection is complete when:

the pen emits a second “click” or
the yellow indicator fills the inspection
window
This takes up to
15seconds.

Yellow indicator
STEP 8Once the injection is complete, slowly remove
the pen from the skin.
The white needle protection sleeve
will cover the needle tip and emit another
“click”.
After completing the injection, apply
a cotton ball or gauze to the skin
at the injection site.

Do notrub the injection site
It is normal to have slight
bleeding at the injection
site

STEP 9Dispose of the used pen in a special waste
container immediately after use.

Do notdispose of the used pen in the
household waste
Your doctor, pharmacist or nurse will
explain how to return the waste container
once it is full
\10

Skyrizi 150 mg injectable solution in pre-filled syringe

risankizumab

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you use Skyrizi
• 3. How to use Skyrizi
• 4. Possible side effects
• 5. How to store Skyrizi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Skyrizi 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 for the treatment of adults with moderate to severe plaque psoriasis. Skyrizi
reduces inflammation and can therefore help to reduce the symptoms of plaque psoriasis, such as burning,
itching, pain, redness and scaling.
Psoriatic arthritis
Skyrizi is used for the treatment of adults with psoriatic arthritis. Psoriatic arthritis is a disease
that causes inflammation of the joints 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 to reduce pain, stiffness and swelling in and around
the joints, pain and stiffness of the spine, psoriatic skin rash, psoriatic nail damage and may slow down damage to the bones and cartilage of the
joints. These effects can make normal daily activities easier, reduce fatigue and
improve quality of life.

2. What you need to know before you use Skyrizi

Do not use Skyrizi

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

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

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

It is important to record the batch number of the Skyrizi pack.
Each time you receive a new pack of Skyrizi, write down the date and batch number (which can be found
on the pack after “Lot/Lotto”) and keep this information in a safe place.
Serious allergic reactions
Skyrizi can cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Tell your doctor immediately or seek immediate medical help if you notice any signs of an allergic reaction during
treatment with Skyrizi, such as:

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

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

Other medicines and Skyrizi
Tell 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 a vaccination. You should not receive certain types of vaccine while using Skyrizi.

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

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This is because it is not known whether this medicine can harm the
baby.
If you are a woman of childbearing potential, you should use appropriate contraception during use of 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 and operate machines.

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 following exactly the instructions of 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 equal to 150 mg, to be administered with a single injection. After the first dose, you will receive
the next dose 4 weeks later and, subsequently, every 12 weeks.
You may decide together with your doctor, pharmacist or nurse to self-administer this
medicine. Do not self-administer this medicine before receiving instructions from your doctor,
pharmacist or nurse.
Someone caring for you can also administer the injection, after being trained.

Before injecting Skyrizi, carefully read paragraph7 “Instructions for Use”, at the end of
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or if the dose was administered to you before it was prescribed,
inform your doctor.

If you forget to use Skyrizi
If you have forgotten to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, contact
your doctor.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, the
symptoms may reappear.
If you have any doubts about the use of this medicine, contact 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 medical treatment. Tell your doctor immediately 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 can cause dizziness or mild confusion

Tell your doctor immediately or seek immediate medical attention if the following symptoms appear.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that does not go away
• warm, red and painful skin, or painful rash with blistering

The doctor will decide if you can continue to use 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 airway infections with symptoms such as sore throat and nasal congestion

Common:may affect up to 1 in 10 people

• feeling tired
• fungal skin infections
• reactions at the injection site (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 get any side effects, 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 which is stated on the syringe label and on the
pack after ‘EXP/Scad.’.
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, you can also store the pre-filled syringe outside the refrigerator (up to 25 °C) for a
maximum period 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 any medicine in 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 ingredient 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 Skyrizi and package contents
Skyrizi is a clear liquid, from colorless to yellow, available in a pre-filled syringe with
needle protection 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 on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
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

7. Instructions for Use

Read the entire section7 before using Skyrizi
Skyrizi pre-filled syringe
Plunger Flange Needle cap

Syringe body
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
• Store Skyrizi in its original packaging to protect the medicine from light until you are ready to use it
• Do notinject 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 notshake the syringe
• Wait to remove the needle cap until just before the injection

Return this medicine to the pharmacy

• beyond the expiration 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 package from the refrigerator and let it stand at room
temperature, away from direct sunlight, for 15-30minutesbefore giving the injection.

• Skyrizi should not be warmed in any other way (e.g., in a microwave oven or in hot water)
• Keep the syringe in the case until you are ready to inject

Follow these instructions each time you use Skyrizi
STEP 1Remove the pre-filled syringe from the
cardboard case by holding it by the flange.

Do notgrip or pull the plunger when
removing the pre-filled syringe
from the case
Arrange the following items on a clean
flat surface:
1 pre-filled syringe
1 alcohol-soaked 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 2
Injection sites
Choose one of these three injection sites:
front of the left thigh
front of the right thigh
abdomen (belly), at least 5 cm

from the navel
Before the injection, rub the
chosen area in a circular motion with an
alcohol-soaked swab.

Do nottouch or blow on the injection site
after cleaning it. Let the
skin dry before giving the injection

Do notinject through clothing

Do notinject into irritated, bruised,
reddened, hardened, scarred or
stretch-marked skin

Do notinject into areas affected by psoriasis

Injection sites
STEP 3Hold the syringe with the covered needle
pointing downwards, as shown.
Check the liquid in the syringe.

It is normal to see bubbles in the
window
The liquid should be clear to yellow and
may contain small white or
transparent particles

Do notuse it if the liquid is cloudy or
contains flakes or large
particles
L

Check the liquid
STEP 4Remove 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 nothold or pull the plunger when
removing the needle cap
You may see a drop of liquid
at the end of the needle. This is normal
Dispose of the needle cap

Do nottouch the needle with your fingers or touch
anything with the needle

STEP 5Hold the syringe body in one hand
between your thumb and index finger, as if it were a
pencil.
With the other hand, gently lift a
fold of cleansed skin and hold it
firmly.
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.

STEP 6Slowly and
completely push the plunger, until all the
liquid is injected.
Withdraw the needle from the skin keeping the
syringe at the same angle.
Slowly release your thumb from the plunger.
The needle will then be covered by the
needle protection.
Ts1

The needle protection will not be activated
until all the liquid has been
injected
If you think you have not injected all the dose,
consult your doctor, pharmacist or
nurse
Press a cotton ball or
gauze pad on the injection site
and hold for 10 seconds.

Do notrub the injection site. Mild
bleeding from the injection site may occur. This is normal.

STEP 7
Needle protection
Dispose of the used syringe in a sharps
container immediately after use.

Do notdispose of the used syringe in the
household waste
Your doctor, pharmacist or nurse
will explain how to return the sharps
container once it is full

Skyrizi 75 mg injectable solution in pre-filled syringe

risankizumab

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use Skyrizi
• 3. How to use Skyrizi
• 4. Possible side effects
• 5. How to store Skyrizi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Skyrizi and what is it 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 for the treatment of adults with moderate to severe plaque psoriasis. Skyrizi
reduces inflammation and can therefore help to reduce the symptoms of plaque psoriasis, such as burning,
itching, pain, redness and scaling.
Psoriatic arthritis
Skyrizi is used for the treatment of adults with psoriatic arthritis. Psoriatic arthritis is a disease
that causes inflammation of the joints 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 to reduce pain, stiffness and swelling in and around
the joints, pain and stiffness of the spine, psoriatic skin rash, psoriatic nail damage and may slow down damage to the bones and cartilage of the
joints. These effects can make normal daily activities easier, 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 any of the other ingredients of this medicine (listed in section 6).
• if you have an infection, including active tuberculosis, which your doctor considers to be significant.

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

• if you currently have an infection or if an infection keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You should not receive certain types of vaccines during the use of Skyrizi.

It is important to record the batch number of the Skyrizi pack.
Each time you receive a new pack of Skyrizi, note the date and batch number (which is found
on the pack after “Lot/Batch”) and keep this information in a safe place.
Serious allergic reactions
Skyrizi can cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Tell your doctor immediately or seek immediate medical help if you notice any signs of an allergic reaction during
treatment with Skyrizi, such as:

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

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

Other medicines and Skyrizi
Tell 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 a vaccination. You should not receive certain types of vaccine during the use of Skyrizi.

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

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This is because it is not known whether this medicine can harm the
baby.
If you are a woman of childbearing potential, you should use effective contraception during the use of 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 and operate machines.

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, that is to say essentially
"sodium-free".

3. How to use Skyrizi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
This medicine is administered with 2 injections under the skin (subcutaneous injections).

How much Skyrizi to use
The dose is 150 mg, to be administered with two 75 mg injections.
You and your doctor, pharmacist or nurse can decide together whether you will self-administer this
medicine, but only if they provide you with instructions on how to inject the medicine. Also, someone
caring for you can administer the injections, after being trained.

Before injecting Skyrizi, carefully read paragraph7 “Instructions for Use”, at the end of
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or if the dose was administered to you earlier than prescribed,
inform your doctor.

If you forget to use Skyrizi
If you have forgotten to use Skyrizi, inject a dose as soon as you remember. If you have any doubts, contact
your doctor.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, the
symptoms may reappear.
If you have any doubts 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 everybody gets them.

Serious side effects
Allergic reactions - these may require urgent medical treatment. Tell your doctor immediately or seek immediate medical attention if you experience any of the following symptoms:
Serious allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000). Symptoms include:

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

Tell your doctor immediately or seek immediate medical attention if you experience the
following symptoms.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that does not go away
• warm, red and painful skin, or painful rash with blistering

Your doctor will decide whether you can continue to use 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
• reactions at the injection site (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 get any side effects, 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 which is stated on the syringe label and on the
pack 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 in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. 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 75 mg of risankizumab in 0.83 mL of solution.
• The other ingredients 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 liquid, from colourless to slightly yellow, available in a pre-filled syringe
with a needle protection device. The liquid may contain small white or transparent particles.
Each pack contains 2 pre-filled syringes and 2 alcohol-soaked 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, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (free of charge)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. Z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
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

7. Instructions for Use

Read the entire section7 before using Skyrizi
Plunger Flange Needle cap

Syringe body
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
• Store Skyrizi in its original packaging to protect the medicine from light until you are ready to use it
• Do notinject 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 notshake the syringe
• Wait to remove the needle cap until just before the injection

Return this medicine to your pharmacy

• beyond the expiration date (Exp.)
• if the liquid has been frozen (even after thawing)
• if the syringe has been dropped or is damaged
• if the paper cover of the syringe tray is broken or missing

For a more comfortable injection:Remove the package from the refrigerator and let it sit at room temperature, away from direct sunlight, for 15–30minutesbefore giving the injection.

• Skyrizi should not be heated in any other way (e.g., in a microwave or in hot water)
• Keep the syringes in the case until you are ready to inject

Follow these instructions each time you use Skyrizi
STEP 1Arrange the following items on a clean, flat surface:
2 prefilled syringes and 2 alcohol swabs

soaked in alcohol (included in the
package)
2 cotton balls or gauze pads
(not included in the package)
Sharps container (not
included in the package)
Wash and dry your hands.
Start with one syringe for the first injection.

For a complete dose, 2injections are required, one after the other.
STEP 2
Injection sites
Choose one of these three injection sites:
front of the left thigh
front of the right thigh
abdomen (belly), at least 5 cm

from the navel
For the second syringe, inject at least 3 cm
from the first injection. Do notinject in the same
place.
Before each injection, rub the
chosen area with a circular motion with an
alcohol swab.

Do nottouch or blow on the injection site
after cleaning it. Let the
skin dry before giving the injection

Do notinject through clothing

Do notinject into irritated, bruised,
reddened, hardened, scarred or
stretch-marked skin

Injection sites
Do notinject into areas affected by psoriasis

STEP 3Hold the syringe with the covered needle pointing
downward, as shown.
Check the liquid in the syringe.

It is normal to see bubbles in the
window
The liquid should be clear or
slightly yellow and may contain
small white or transparent particles

Do notuse it if the liquid is cloudy or
contains flakes or large
particles

Check the liquid
STEP 4Remove 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 nothold or pull the plunger when
removing the needle cap
You may see a drop of liquid
at the end of the needle. This is normal
Discard the needle cap

Do nottouch the needle with your fingers or touch
anything with the needle

STEP 5Hold the syringe body with one hand
between your thumb and index finger, as if it were a
pencil.
With the other hand, gently lift a
fold of cleansed skin and hold
it firmly.
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.

STEP 6Slowly and
completely push the plunger, until all the
liquid is injected.
Withdraw the needle from the skin keeping the
syringe at the same angle.
Slowly release your thumb from the plunger.
The needle will then be covered by the safety
shield.

The safety shield will not be activated
until all the liquid is
injected
If you think you have not injected all the dose,
consult your doctor, pharmacist or
nurse
Press a cotton ball or
gauze pad on the injection site
and hold for 10 seconds.

Do notrub the injection site. Mild
bleeding from the injection site may occur. This is normal.

STEP 7
Needle protection
For a complete dose, 2injections are required, 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

2 injections are requiredinjection

STEP 8Dispose of the used syringes in a sharps container immediately after use.

Do notdispose of used syringes in household
waste
Your doctor, pharmacist or nurse will
explain how to return the sharps container
once it is full

Skyrizi 600 mg concentrate for solution for infusion

risankizumab

Read this leaflet carefully before you use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you receive 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 is Skyrizi and what is it used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used for the treatment of 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 digestive tract. If you have active Crohn’s disease,
you will initially be given other medicines. If these medicines are not
sufficiently effective, you will be given Skyrizi to treat 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, you will be given Skyrizi to treat
ulcerative colitis.
Skyrizi reduces inflammation and can therefore help to alleviate the signs and symptoms of the disease.

2. What you need to know before you receive Skyrizi

You should not receive Skyrizi

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

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

• if you currently have an infection or if an infection recurs repeatedly.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You should not receive certain types of vaccines during the use of 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 should note the date and
the batch number (which is found on the pack after “Lot”).
Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor immediately or seek immediate medical help if you notice any signs of an allergic reaction during
treatment with Skyrizi, such as:

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

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

Other medicines and Skyrizi
Tell 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 a vaccination. You should not receive certain types of vaccines during the use of Skyrizi.

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

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This is because it is not known whether this medicine can harm the
baby.
If you are a woman of childbearing potential, you should use adequate contraception during the use of 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 and use machines.

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 begin with an initial dose, which will be administered to you by your doctor or
nurse via an intravenous infusion (drip in your arm).

Initial doses
Subsequently, Skyrizi will be administered to you as a subcutaneous injection. Please consult the package
leaflet of Skyrizi 90 mg in a prefilled syringe, 180 mg and 360 mg injectable solution in a cartridge.

Maintenance doses
If you forget to use Skyrizi
If you forget or miss your appointment for the administration of a dose, 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, the
symptoms may reappear.
If you have any doubts 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 everybody gets them.

Serious side effects
Allergic reactions - these may require urgent medical treatment. Tell your doctor immediately or seek immediate medical attention if you experience any of the following symptoms:
Serious 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 can cause dizziness or lightheadedness

Tell your doctor immediately or seek immediate medical attention if you experience the
following symptoms.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that does not go away
• warm, red, and painful skin, or painful rash with blisters

Your doctor will decide if you can continue to use Skyrizi.

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

Very common:may affect more than 1 in 10 people

• upper respiratory 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
• reactions at the injection site (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 get any side effects, 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 hospital or clinic and
it is not the patients’ 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 which is stated on the vial label and on the
pack 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. Vigorous and prolonged shaking of the vial 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 in waste water or household waste. This will help protect
the environment.

6. Package contents and other information

What Skyrizi contains

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

Description of Skyrizi and package contents
Skyrizi is a clear liquid, from colourless to slightly yellow, 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
or
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
For further information on this medicine, contact the local representative of the marketing
authorisation holder:
EL -

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (free of charge)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
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 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

---------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:
Traceability
In order to improve the traceability of biological medicines, the name and
batch number of the medicine administered must be clearly recorded.
Instructions for use

• 1. This medicine must be prepared by a qualified healthcare professional using 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 bottle containing 5% dextrose in water (D5W) or 0.9% sodium chloride solution (0.9%) to a final concentration between approximately 1.2 mg/mL and 6 mg/mL. For dilution instructions based on the patient indication, see the table below.

• 4. The solution in the vial and the diluted solution must not be shaken.

• 5. Before starting the intravenous infusion, the contents of the infusion bag or glass bottle must be at room temperature.
• 6. Infuse the diluted solution over at least one hour for the 600 mg dose and at least two hours for the 1200 mg dose.
• 7. The solution in the vial must not be administered concurrently with other medicines in the same infusion line. Each vial is for single use only and unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Storage of diluted solution
Chemical and physical stability in use 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 between the start of dilution and the start
of infusion) at room temperature (protected from light). Exposure to internal light is
acceptable during storage at room temperature and administration.
From a microbiological point of view, the prepared infusion must be used immediately. If not
used immediately, storage times and conditions before use are the responsibility of the user and must not exceed 20 hours at a
temperature of 2°C-8°C. Do not freeze.

Skyrizi 180 mg injectable solution in cartridge, 360 mg injectable solution in cartridge

risankizumab

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use Skyrizi
• 3. How to use Skyrizi
• 4. Possible side effects
• 5. How to store Skyrizi
• 6. Contents of the pack and other information
• 7. Instructions for use

1. What is Skyrizi and what it is used for

Skyrizi contains the active substance risankizumab.
Skyrizi is used for the treatment of 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 digestive tract. If you have active Crohn’s
disease, you will initially be given other medicines. If these medicines are not
sufficiently effective, you will be given Skyrizi for the treatment of 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, you will be given Skyrizi for the treatment
of ulcerative colitis.
Skyrizi reduces inflammation and can therefore help to alleviate 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 any of the other ingredients of this medicine (listed in section 6).
• if you have an infection, including active tuberculosis, which your doctor considers to be important.

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

• if you currently have an infection or if an infection keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You should 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 batch number (which can be found
on the pack after “Lot”) and keep this information in a safe place.
Serious allergic reactions
Skyrizi can cause serious side effects, including severe allergic reactions (‘anaphylaxis’).
Tell your doctor immediately or seek immediate medical help if you notice any signs of an allergic reaction during
treatment with Skyrizi, such as:

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

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

Other medicines and Skyrizi
Tell 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 a vaccination. You should not receive certain types of vaccines while using Skyrizi.

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

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This is because it is not known whether this medicine can harm the
baby.
If you are a woman of childbearing potential, you must use effective contraception during use of 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 use machines.

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

3. How to use Skyrizi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, ask your doctor or pharmacist.
This medicine is administered by injection under the skin (subcutaneous injection).

How much Skyrizi to use
Treatment with Skyrizi will begin with an initial dose, which will be administered to you by your doctor or
nurse via an intravenous infusion (drip into a vein).

Initial doses
Subsequently, Skyrizi will be administered to you as an injection under the skin.

Maintenance doses
You may decide together with your doctor, pharmacist or nurse to self-administer this
medicine. Do not self-administer this medicine before receiving instructions from your doctor,
pharmacist or nurse. Someone caring for you can also administer the injection, after being
trained.

Before injecting Skyrizi, carefully read section 7 “Instructions for use” at the end of
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or if the dose was administered to you 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, contact your
doctor.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, the
symptoms may return.
If you have any further questions on 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 everybody gets them.

Serious side effects
Allergic reactions - these may require urgent medical treatment. Tell your doctor immediately or seek immediate medical attention if any of the following symptoms occur:
Serious allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000). Symptoms include:

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

Tell your doctor immediately or seek immediate medical attention if the following symptoms appear.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that does not go away
• skin that is warm, red and painful, or painful rash with blistering

The doctor will decide if you can continue to use 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
• reactions at the injection site (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 get any side effects, 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 which is stated on the label of the vial and on the
pack after “Exp.”.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, you can also store the cartridge outside the refrigerator (up to 25 °C) for a maximum period of
24 hours.
Keep the cartridge 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.
Each on-body injector with cartridge is for single use only.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Skyrizi contains
The active ingredient 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 liquid and from colourless to yellow 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 on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (free of charge)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
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 updated 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

7. Instructions for Use

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

Gray
door
Do not close the
gray door
without the cartridge
inside
Medicine
window
Tabs

Rear view
Transparent
plastic
strip
Needle cover Adhesive support

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

Side view
Door
stop
The opening side has
grooves
The gray door must be
slightly open
Do not close the gray
door without the cartridge
inside
Needle
cover
Needle inside (under the
needle cover)
Do not touch the
needle cover area or the needle

Cartridge
The white plunger
expands into the chamber
towards the bottom of the
cartridge
as the medicine is
injected.
Medicine
Smaller
bottom tip

Larger
top of
the cartridge
Do not rotate or remove
Expiration date (Exp.)
Located on the
cartridge label
F-

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 for use exclusively with the Skyrizi cartridge
• Store Skyrizi in its original packaging to protect the medicine from light until you are ready to use it
• Remove the package from the refrigerator and let it stand at room temperature, away from direct sunlight, for at least 45 and up to 90 minutesbefore giving the injection
• Do notwet the on-body injector with water or other liquids
• Do nottouch the start button until you have positioned the on-body injector loaded with the cartridge on your skin and are ready for the injection

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 permitted
• Do notdelay the injection of the medicine after loading the clean cartridge into the on-body injector. Waiting will cause the medicine to dry out and the on-body injector to malfunction
• Do notinject 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 notshake the box, cartridge, or on-body injector
• Do notreuse the cartridge or on-body injector

Return this medicine to the pharmacy

• beyond the expiration date (Exp.)
• if the liquid has been frozen (even after thawing)
• if the cartridge or on-body injector has been dropped or is damaged
• if the packaging perforations 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
stand at room temperature, away from direct
sunlight, for at least 45 and up to 90 minutesbefore
giving the injection.

• Check the expiration date (Exp.) on the packaging. Do not use Skyrizi beyond the expiration date (Exp.).
• Do notremove the cartridge or on-body injector from the packaging until Skyrizi has reached room temperature
• Do notheat Skyrizi in any other way. For

1 B
example, do notheat Skyrizi in the microwave or
in hot water
Special waste container Collect all materials and wash your hands
Arrange 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)
• special waste 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 cover

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

Gray
door
Start
button

Needle inside
(under the
needle cover)

Inspect the on-body injector

• Check that the on-body injector is intact and undamaged
• The gray door should be slightly open
• If the gray door does not open, press firmly on the grooves (left side of the door) and open the door
• Do notclose the gray door before the cartridge is loaded
• Do notuse the on-body injector if it has been dropped, if you notice missing parts, or if it is damaged
• Do nottouch the gray start button until the time of injection. It can only be pressed once
• Do nottouch the needle cover area or the needle

The Skyrizi on-body injector cannot be used if
you press the gray start button before
positioning it on the body. In this case, consult
your doctor, pharmacist, or nurse.

STEP 2 - Preparing the on-body injector
Gray door Open the gray door completely
Rear view

Needle inside
(under the
needle cover)
Needle
cover

• Avoid touching the needle cover area or the back

End of the on-body injector. The needle is located behind the
needle cover

• Rotate the gray door completely to the right to open it
• If the gray door does not open, press firmly on the grooves (left side of the door) and open the door
• Do notclose the gray door before the cartridge is loaded

Set the on-body injector aside.
Larger top of the cartridge
Tip

Inspect the cartridge
Carefully remove the cartridge from the
plastic tray.

• Do notrotate or remove the top 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 notuse the cartridge if the liquid is cloudy or contains flakes or large particles
• Check that the parts of the cartridge and the transparent plastic are not cracked or broken
• Do notuse the cartridge if the liquid has been frozen (even after thawing).
• Do notuse the cartridge if it has been dropped, if you notice missing parts, or if it is damaged. smaller bottom

Clean the smaller bottom tip of the
cartridge
Locate the smaller bottom tip of the cartridge

• Clean the smaller bottom tip of the cartridge with an alcohol swab. Use the alcohol swab to clean the central part of the smaller bottom tip of the cartridge
• Do nottouch the smaller bottom tip of the cartridge after cleaning it.

Clean the central
part of the smaller
bottom tip
Insert vertically
“click”

Load the clean cartridge into the on-body injector

• Do notrotate or remove the top of the cartridge
• First, insert the smaller bottom tip of the cartridge into the on-body injector
• Push the top of the cartridge down firmly until you hear a “click”
• Once the cartridge is loaded, you may notice a few drops of medicine on the back of the on-body injector. This is normal

Proceed to the next step immediately. Waiting will
cause the medicine to dry out.

2D

Close the gray door
Rotate the gray door to the left, then tighten
firmly and wait for the door to click shut

• The gray door should remain locked once the cartridge is loaded
• Do notclose the gray door if the cartridge is not fully inserted or is missing
• Proceed to the next step immediately

/--
“click”

STEP 3 - Preparing for the injection
Injection sites

Select and clean the injection site
Choose one of these three injection sites:

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

Do notinject into areas of skin that have folds
or natural bumps, as the on-body injector
could fall off during use.
Before the injection, rub the chosen area in a
circular motion with an alcohol swab.

• Do nottouch or blow on the injection site after cleaning it. Let the skin dry before placing the on-body injector on the skin
• Do notinject through clothing
• Do notinject on irritated, bruised, reddened, hardened, scarred, or stretch-marked skin, moles, or excessive hair. You can trim excess hair from the injection site Injection sites

Small section Large section Remove the two tabs to expose the skin
adhesive
Turn the on-body injector to find the two green
tabs

• Avoid touching the needle cover (needle inside)

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

• Check the status indicator when the on-body injector beeps
• The status indicator flashes blue when the on-body injector is activated
• If the status indicator does not flash blue, consult your doctor, pharmacist, or nurse
• Do notpress the gray start button yet
• Do nottouch the needle cover or the needle
• Do nottear the adhesive material from the on-body injector and prevent the adhesive side from folding over and sticking to itself

The Skyrizi on-body injector must be
positioned on the skin and the injection must begin
within 30 minutes of removing the green tabs,
otherwise the injector will not work. Proceed
to the next step.

Needle
inside
(under the
needle cover)

Injector
activated
Status light
blue
flashing

3B
,
or P

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

Prepare the on-body injector for positioning

• For the abdomen, tense the skin to create a stable, flat surface for the injection, at least 5 cm from the navel. Make sure you are sitting upright to avoid skin folds and bumps.
• For the front of the left thigh or right thigh, you do not need to tense the skin to make it flat.

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

Position the on-body injector on the skin

• When the blue status light is flashing, the on-body injector is ready. Position the on-body injector on clean skin with the status light visible
• Do notposition the on-body injector on clothing, but only on bare skin.
• Run your finger around the adhesive material to secure it
• Do notmove or adjust the on-body injector once it is positioned on the skin

Immediately proceed to the next step.

STEP 4 - Skyrizi Injection

Start the injection
Press firmly and release the gray start button

• You will feel a “click” and may feel the needle prick
• Check the status light when the on-body injector beeps
• After the injection starts, the status light will flash continuously green
• After the injection starts, you will hear sounds similar to those made by a pump as the on-body injector delivers the medication

Do notcontinue to use 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

• Delivering the full dose of medication may take up to 5 minutes. The on-body injector will stop automatically when the injection is finished
• During the injection, the status light will continue to flash green
• During the injection, you will hear pulsating sounds as the on-body injector continues to deliver the medication
• Moderate physical activity, such as walking, stretching, and bending, is permitted during the injection.

Do notcontinue to use 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.
“click”

4B
,

The injection is complete when:

• The on-body injector stops on its own
• You hear a beep and the status light turns solid green. If the status light has turned solid green, this means the injection is complete 4C

Remove the on-body injector

• Do notput your fingers on the back of the on-body injector when removing it from the skin
• When the injection is finished, grasp the corner of the adhesive to carefully peel the on-body injector from the skin
• Avoid touching the needle cover or the needle on the back of the on-body injector
• After removing the on-body injector, you will hear several beeps and the status light will turn off
• The needle cover protects the needle when the on-body injector is removed from the skin
• It is normal to see some 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 it for 10 seconds
• Do notrub the injection site
• It is normal for slight bleeding to occur at the injection site

Proceed to the next step.

STEP 5 - Completion

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 status light
is off, indicating that all the medicine has been
injected.

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

Special waste container Disposal
Place the used on-body injector in a special
waste container immediately after use.

• The on-body injector contains batteries, electronic components and a needle.
• Leave the cartridge inside the on-body injector.
• Do notthrow the used on-body injector in household waste.
• Your doctor, pharmacist or nurse will explain how to return the special waste container once it is full. There may be local guidelines for disposal.

Skyrizi 90 mg injectable solution in pre-filled syringe

risankizumab

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you receive 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 is Skyrizi 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.

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 disease of the digestive tract. If you have active Crohn's
disease, you will initially be given other medicines. If these medicines are not
sufficiently effective, you will be given Skyrizi to treat Crohn's disease.
Skyrizi reduces inflammation and can therefore help to alleviate the signs and symptoms of the disease.

2. What you need to know before you receive Skyrizi

Do not receive Skyrizi

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

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

• if you currently have an infection or if an infection keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or are due to receive a vaccine. You should 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 should record the date and
the batch number (which is found on the pack after “Lot/Lotto”).
Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor immediately or seek immediate medical help if you notice any signs of an allergic reaction during
treatment with Skyrizi, such as:

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

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

Other medicines and Skyrizi
Tell 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 a vaccination. You should not receive certain types of vaccine while using Skyrizi.

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

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This is because it is not known whether this medicine could harm the
baby.
If you are a woman of childbearing potential, you should use effective contraception during use of 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 and 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 your doctor or
nurse via an intravenous infusion (drip into your arm).

Initial doses

Subsequently, Skyrizi will be administered to you as a subcutaneous injection (“injection
under the skin”). The administration will be performed by your doctor or nurse in the form of four
injections under the skin, as described below. Alternatively, Skyrizi can be administered with
an on-body injector.

Maintenance doses
If you forget to use Skyrizi
If you forget or miss your appointment for the administration of a dose, 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, your
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 everybody gets them.

Serious side effects
Allergic reactions - these may require urgent medical treatment. Tell your doctor immediately or seek immediate medical attention if you experience any of the following symptoms:
Serious allergic reactions (anaphylaxis) are rare in people taking Skyrizi (may affect more than 1 in 1,000). Symptoms include:

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

Tell your doctor immediately or seek immediate medical attention if you experience the
following symptoms.
Symptoms of a serious infection, such as:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that does not go away
• warm, red and painful skin, or painful rash with blistering

The doctor will decide if you can continue to use 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
• reactions at the injection site (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 get any side effects, 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 which is stated on the syringe label and on the
pack 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 in waste water or household waste. This will help protect
the environment.

6. Content 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 liquid, from colourless to slightly yellow, available in a pre-filled syringe
with 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, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (free of charge)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
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.

---------------------------------------------------------------------------------------------------------------------------

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
medicinal product administered must be clearly recorded.

Skyrizi pre-filled syringe
Plunger Flange Needle cap

Syringe body
Instructions for use
This medicinal product must be administered by a healthcare professional.
Administer each pre-filled syringe by subcutaneous injection as follows:

STEP 1Before performing the injection, remove the
pack from the refrigerator without removing the
pre-filled syringes from the pack.

• Do notuse this medicinal product if the

seal of the pack is broken or
missing or if one of the components
is damaged.
Allow Skyrizi to reach room temperature away from direct sunlight
(15 to 30 minutes).

Do notshake the pre-filled syringes.
Place the following items on a flat and
clean surface:

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

Wash and dry your hands.

For a complete dose, 4
injections are required, one after the other.
STEP 2
Injection sites
Choose an injection site.

• Inject a pre-filled syringe after another in the following anatomical areas:

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

• Use a new site for each injection.
• For each syringe, inject at least Injection sites3 cm from the previous injection. Do notinject in the same place.

Before each injection, rub the
chosen area with circular movements with an
alcohol swab.

• Do notinject into areas where the skin is sensitive, bruised, erythematous, thickened or affected by lesions.

STEP 3Hold the syringe with the covered needle
pointing downwards, as shown.
Check the liquid in the syringe.

• It is normal to see bubbles in the window
• The liquid should be clear to yellow and may contain small white or transparent particles
• Do notuse it if the liquid is cloudy or contains flakes or large particles

Check the liquid

STEP 4Remove 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 nothold or pull the plunger when removing the needle cap
• You may see a drop of liquid at the end of the needle. This is normal
• Dispose of the needle cap
• Do nottouch the needle with your fingers or touch anything with the needle

STEP 5Hold the body of the syringe with one hand
between your thumb and forefinger, as if it were a
pencil.
With the other hand, gently lift a
pinch of cleansed skin and hold it
firmly.
Insert the needle completely into the skin
at an angle of approximately 45 degrees with a
quick and decisive movement. Keep the
syringe at the same angle at all times.
Push the plunger slowly and
completely, until all the
liquid is injected.
Withdraw the needle from the skin keeping the
syringe at the same angle at all times.
Slowly lift your thumb off the plunger.
The needle will then be covered by the protection
of the needle.
The needle protection will not be activated until
all the liquid has been injected
Press a cotton ball or
gauze pad on the injection site
and hold for 10 seconds.

STEP 6

Use four pre-filled syringes of 90
mg 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 the
administration following the prescribed
schedule.

For a complete dose, 4 injections are required
STEP 7Each pre-filled syringe is intended
exclusively for single use and any unused medicinal
product or waste material must be disposed of
in accordance with local requirements.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
In light of the evaluation by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for risankizumab, the scientific
conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
In light of the available data on anaphylaxis from spontaneous reports including 6 cases
with a close temporal relationship, the PRAC considers that a causal relationship between risankizumab and anaphylaxis
is at least a reasonable possibility. The PRAC concluded that the medicinal product information
containing risankizumab must be revised accordingly.
After examining the PRAC recommendation, the CHMP agrees with the PRAC’s overall conclusions
and the reasons for the recommendation.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on risankizumab, the CHMP considers that the benefit/risk ratio of the medicinal product containing risankizumab is unchanged subject to the proposed changes
to the medicinal product information.
The CHMP recommends the variation of the terms of the marketing authorisation.