Bimzelx

Package leaflet: Information for the user

Bimzelx 160 mg solution for injection in pre-filled syringe

bimekizumab

This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
  1. What Bimzelx is and what it is used for
  2. What you need to know before using Bimzelx
  3. How to use Bimzelx
  4. Possible side effects
  5. How to store Bimzelx
  6. Contents of the pack and other information Instructions for use

1. What is Bimzelx and what is it used for

What is Bimzelx
Bimzelx contains the active substance bimekizumab.
What Bimzelx is used for
Bimzelx is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis
• Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
• Hidradenitis suppurativa

Plaque psoriasis
Bimzelx is used in adults for the treatment of a skin condition called "plaque psoriasis". Bimzelx reduces symptoms including pain, itching, and skin scaling.

Psoriatic arthritis
Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes joint inflammation, often accompanied by plaque psoriasis. If active psoriatic arthritis is present, other medicines may be given first. If these medicines are not sufficiently effective or if intolerance occurs, you will be given Bimzelx as monotherapy or in combination with another medicine known as methotrexate.

Bimzelx reduces inflammation and may therefore help reduce pain, stiffness, swelling within and around the joints, psoriatic skin rash, nail damage due to psoriasis, and slow down cartilage and bone damage in the joints affected by the disease. These effects may help control the signs and symptoms of the disease, facilitate normal daily activities, reduce fatigue, and improve quality of life.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
Bimzelx is used to treat adults with an inflammatory disease that mainly affects the spine and causes inflammation of the spinal joints, called axial spondyloarthritis. If the condition is not visible on X-rays, it is referred to as "non-radiographic axial spondyloarthritis"; if patients show visible X-ray changes, it is referred to as "ankylosing spondylitis" or "radiographic axial spondyloarthritis".

If you have axial spondyloarthritis, you will initially be given other medicines. If you do not respond adequately to these medicines, you will receive Bimzelx to reduce the signs and symptoms of the disease, reduce inflammation, and improve physical function. Bimzelx may help reduce back pain, stiffness, and fatigue, which could help you carry out normal daily activities and improve your quality of life.

Hidradenitis suppurativa
Bimzelx is used in adults to treat a condition called hidradenitis suppurativa (sometimes referred to as acne inversa or Verneuil’s disease). Hidradenitis suppurativa is a chronic inflammatory skin disease that causes painful lesions such as tender nodules, abscesses (pockets containing pus), and draining wounds. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas. You will first be given other medicines. If you do not respond sufficiently to these medicines, you will be given Bimzelx.

Bimzelx reduces inflammatory nodules, abscesses (pockets containing pus), and draining wounds, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab works by reducing the activity of two proteins called IL-17A and IL-17F, which are involved in the development of inflammation. In inflammatory diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, levels of these proteins are elevated.

2. What you should know before using Bimzelx

Do not use Bimzelx

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bimzelx if:

• you have an infection or a recurring infection;
• you have recently received or are planning to receive a vaccination. You must not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis)
Stop using Bimzelx and contact your doctor or seek immediate medical attention if you notice blood in your stool, abdominal cramps, pain, diarrhoea, or weight loss. These could be signs of a new inflammatory bowel disease or worsening of an existing inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
Be alert for infections and allergic reactions
Bimzelx may rarely cause serious infections. Contact your doctor or seek immediate medical attention if you notice any signs indicating a serious infection. These signs are listed in section 4 “Serious unwanted effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek immediate medical attention if you notice any signs indicating a severe allergic reaction. These signs may include:

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

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Bimzelx
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. It is preferable to avoid using Bimzelx during pregnancy. This is because it is not known whether this medicine could harm the unborn baby.
If you are a woman of childbearing potential, you should use a contraceptive method during treatment with this medicine and for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or intend to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether you can breastfeed or take Bimzelx.
Driving and using machines
It is unlikely that Bimzelx will affect your ability to drive or operate machinery.
Bimzelx contains polysorbate 80
This medicine contains 0.4 mg of polysorbate 80 per mL of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Bimzelx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to use Bimzelx

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Bimzelx is administered and for how long
Plaque psoriasis
The recommended dose, administered via injections under the skin (‘subcutaneous injections’), is as
follows:

• 320 mg (administered with two pre-filled syringes containing 160 mg each) at weeks 0, 4, 8, 12, 16;
• from week 16 onwards, you will use 320 mg (two pre-filled syringes containing 160 mg each) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue injections every 4 weeks starting from week 16. Psoriatic arthritis The recommended dose, administered via injection under the skin (‘subcutaneous injection’), is as follows:
• 160 mg (administered with one pre-filled syringe containing 160 mg) every 4 weeks.
• In cases of psoriatic arthritis with moderate to severe coexisting plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust the injections to 160 mg every 4 weeks, depending on joint symptoms.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
The recommended dose, administered via injection under the skin (‘subcutaneous injection’), is as
follows:

• 160 mg (administered with one pre-filled syringe containing 160 mg) every 4 weeks. Hidradenitis suppurativa The recommended dose, administered via subcutaneous injections, is as follows:
• 320 mg (administered with two pre-filled syringes, each containing 160 mg) every 2 weeks up to week 16.
• From week 16 onwards, you will use 320 mg (two pre-filled syringes, each containing 160 mg) every 4 weeks. You and your doctor or nurse will decide whether you can self-administer this medicine. Do not perform the injection yourself unless you have been trained by a healthcare professional. A caregiver may also administer the injection after proper training. Before injecting Bimzelx 160 mg solution for injection in a pre-filled syringe yourself, carefully read the ‘Instructions for use’ at the end of this package leaflet. If you use more Bimzelx than you should Inform your doctor if you have received more Bimzelx than you should, or if the dose was administered earlier than scheduled. If you forget to use Bimzelx Speak with your doctor if you have forgotten to inject a dose of Bimzelx. If you stop using Bimzelx Talk to your doctor before stopping treatment with Bimzelx. If you stop treatment, symptoms may return. If you have any doubts about how to use 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
Contact your doctor or seek immediate medical help if you experience any of the following side effects.
Possible serious infections, signs may include:

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

Your doctor will assess whether you can continue using Bimzelx.
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 blocked nose
  Common (may affect up to 1 in 10 people)
• oral or throat candidiasis with symptoms such as white or yellow patches; red or sore mouth and pain when swallowing
• fungal skin infections, such as athlete’s foot between the toes
• ear infections
• cold sores (herpes simplex infections)
• stomach upset (gastroenteritis)
• inflamed hair follicles which may look like pimples
• headache
• itching, dry skin or eczema-like rash sometimes with swelling and redness of the skin (dermatitis)
• acne
• redness, pain or swelling and bruising at the injection site
• feeling of tiredness
• fungal infection of the vulvovaginal area (vaginal thrush)
  Uncommon (may affect up to 1 in 100 people)
• decrease in levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• eye discharge with itching, redness and swelling (conjunctivitis)
• blood in the stools, cramps and abdominal pain, diarrhoea or weight loss (signs of intestinal problems).
  Reporting of side effects
  If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
  You can also report side effects directly via the national reporting system listed in Annex V.
  By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimzelx

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp./EXP". The expiry date refers to the last day of that month.
Store in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
Keep the pre-filled syringes in their original packaging to protect the medicine from light.
Bimzelx may be kept outside the refrigerator for up to 25 days, provided it is stored in the outer packaging, at a temperature not exceeding 25 °C and protected from direct light. Do not use the pre-filled syringe after this period. The carton includes a space to record the date when it was removed from the refrigerator.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bimzelx contains

• The active substance is bimekizumab. Each pre-filled syringe contains 160 mg of bimekizumab in 1 mL of solution.
• The other components are glycine, sodium acetate trihydrate, glacial acetic acid, polysorbate 80, and water for injections.

Description of the appearance of Bimzelx and contents of the pack
Bimzelx is a liquid, from clear to slightly opalescent. Its colour may vary from colourless to pale yellowish-brown. It is supplied as a single pre-filled disposable syringe with a needle cap. Bimzelx 160 mg solution for injection in pre-filled syringe is available in packs containing 1 or 2 pre-filled syringes, and in multiple pack configurations consisting of 3 boxes each containing 1 pre-filled syringe, or in multiple pack configurations consisting of 2 boxes each containing 2 pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Brussels, Belgium

Manufacturer
UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine-l’Alleud, Belgium

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

België/Belgique/Belgien
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00

България (Bulgaria)
Ю СИ БИ България ЕООД
Tel: +359 (0) 2 962 30 49

Česká republika (Czech Republic)
UCB s.r.o.
Tel: +420 221 773 411

Danmark (Denmark)
UCB Nordic A/S
Tlf.: +45 / 32 46 24 00

Deutschland (Germany)
UCB Pharma GmbH
Tel: +49 / (0)2173 48 4848

Eesti (Estonia)
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Soome)

Ελλάδα (Greece)
UCB Α.Ε.
Τηλ: +30 / 2109974000

España (Spain)
UCB Pharma, S.A.
Tel: +34 / 91 570 34 44

France
UCB Pharma S.A.
Tél: +33 / (0)1 47 29 44 35

Hrvatska (Croatia)
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

Ireland
UCB (Pharma) Ireland Ltd.
Tel: +353 / (0)1-46 37 395

Ísland (Iceland)
UCB Nordic A/S
Sími: +45 / 32 46 24 00

Italia (Italy)
UCB Pharma S.p.A.
Tel: +39 / 02 300 791

Κύπρος (Cyprus)
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 056300

Latvija (Latvia)
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Somija)

Lietuva (Lithuania)
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Suomija)

Luxembourg/Luxemburg
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00 (Belgique/Belgien)

Magyarország (Hungary)
UCB Magyarország Kft.
Tel.: +36-(1) 391 0060

Malta
Pharmasud Ltd.
Tel: +356 / 21 37 64 36

Nederland (Netherlands)
UCB Pharma B.V.
Tel: +31 / (0)76-573 11 40

Norge (Norway)
UCB Nordic A/S
Tlf: +47 / 67 16 5880

Österreich (Austria)
UCB Pharma GmbH
Tel: +43-(0)1 291 80 00

Polska (Poland)
UCB Pharma Sp. z o.o. / VEDIM Sp. z.o.o.
Tel.: +48 22 696 99 20

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: +351 21 302 5300

România (Romania)
UCB Pharma Romania S.R.L.
Tel: +40 21 300 29 04

Slovenija (Slovenia)
Medis, d.o.o.
Tel: +386 1 589 69 00

Slovenská republika (Slovakia)
UCB s.r.o., organizačná zložka
Tel: +421 (0) 2 5920 2020

Suomi/Finland (Finland)
UCB Pharma Oy Finland
Puh/Tel: +358 9 2514 4221

Sverige (Sweden)
UCB Nordic A/S
Tel: +46 / (0) 40 294 900

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu

Instructions for use

Read all of the following instructions before using Bimzelx 160 mg solution for injection in
pre-filled syringe.
Description of Bimzelx 160 mg in pre-filled syringe ( see Figure A ):

A

Body of
Plunger
the syringe

Plunger
Needle
Grip
head
Important information

• A healthcare provider must show you how to prepare and inject Bimzelx using the 160 mg pre-filled syringe. Do not inject yourself or anyone else until you have been shown the correct way to inject Bimzelx.
• You and/or the person assisting you must read these Instructions for use before each use of Bimzelx.
• Contact your healthcare provider if you or the person assisting you has any questions about how to correctly inject Bimzelx.
• Depending on the prescribed dose, you will need to use 1 or 2 pre-filled syringes of Bimzelx 160 mg. One pre-filled syringe is required for a 160 mg dose, and two pre-filled syringes (one after the other) are required for a 320 mg dose.
• Each pre-filled syringe is for single use only (disposable).
• The 160 mg pre-filled syringe is equipped with a needle safety feature that automatically covers the needle after injection. The needle safety feature helps prevent needlestick injuries to anyone handling the pre-filled syringe after injection. Do not use this medicine and return it to the pharmacy if:
• the expiry date (Exp.) has passed;
• the box seal is broken;
• the pre-filled syringe has been dropped or appears damaged;
• the liquid has been frozen (even after thawing). For a more comfortable injection: remove the pre-filled syringe/ pre-filled syringes of 160 mg from the refrigerator and let them sit on a flat surface at room temperature for 30–45 minutes before injecting.
• Do not heat the syringe/syringes in any other way, for example in a microwave or in hot water.
• Do not shake the pre-filled syringe/syringes.
• Do not remove the needle cap from the pre-filled syringe/syringes until you are ready to inject.

Follow these instructions every time you use Bimzelx.
Step 1: Prepare for injection/injections
Depending on the prescribed dose, place the following items on a flat, well-lit surface,
such as a table:

• 1 or 2 pre-filled syringes of Bimzelx 160 mg
  You will also need (not included in the pack):
• 1 or 2 alcohol swabs
• 1 or 2 clean cotton balls
• 1 sharps disposal container. See “Disposal of used Bimzelx pre-filled syringe” at the end of these Instructions for use. Step 2: Choose the injection site and prepare the injection 2a: Choose the injection site
• The areas you can choose for injection are:
• stomach (abdomen) or thigh ( see Figure B );
• the back of the upper arm ( see Figure C ). Bimzelx may be injected into the back of the upper arm only by a healthcare provider or another person.

B C

abdomen or
back of the
thigh
upper arm

• Do not inject into areas where the skin is tender, bruised, red, flaky, hard, or areas with scars or stretch marks.
• Do not inject within 5 cm of the navel.
• If a second injection is required for the prescribed dose (320 mg), use a different injection site for the second injection. Do not use the same site for two consecutive injections. 2b: Wash your hands thoroughly with soap and water and dry them with a clean towel 2c: Prepare the skin
• Clean the injection site with an alcohol swab. Allow the area to dry completely. Do not touch the cleaned area again before the injection.

2d: Check the pre-filled syringe (see Figure D)

• Make sure the name Bimzelx and the expiry date are visible on the label.
• Check the medicine through the viewing window. The medicine should range from clear to slightly opalescent and be free of particles. Its color may vary from colorless to pale yellow-brown. You may see air bubbles in the liquid: this is normal.
• Do not use the Bimzelx pre-filled syringe if the medicine is cloudy, discolored, or contains particles.

D

Expiry date
Step 3: Inject Bimzelx
3a: Remove the needle cap from the pre-filled syringe

• Hold the finger grip of the pre-filled syringe with one hand. With the other hand, remove the needle cap from the pre-filled syringe ( see Figure E ). You may see a drop of liquid at the tip of the needle; this is normal.
• Do not touch the needle and do not let the needle touch any surface.
• Do not press the plunger while removing the cap. If you accidentally remove the plunger rod, discard the pre-filled syringe into the sharps disposal container and take a new one.
• Do not recap the needle. This may damage the needle or cause a needlestick injury.

E

3b: With one hand, gently pinch and hold between your fingers a fold of skin that you have cleaned
for injection. With the other hand, insert the needle into the skin at an angle of approximately 45 degrees

• Push the needle fully in. Then gently release the skin. Make sure the needle is in place ( see Figure F ).

F

45°

3c: Press the plunger head all the way down until all the medicine has been injected
(see Figure G)

G

• All the medicine will have been injected when you can no longer push the plunger head any further ( see Figure H ).

H

3d: Remove your thumb from the plunger head (see Figure I). The needle will automatically retract
and lock into place

I

• Press a dry cotton ball on the injection site for a few seconds. Do not rub the injection site. You may see slight bleeding or a drop of liquid: this is normal. You may cover the injection site with a small plaster if needed. Step 4: Dispose of the used Bimzelx pre-filled syringe Immediately after use, place the used pre-filled syringe into a sharps disposal container ( see Figure J ).

J

If a second injection is required as prescribed by your doctor, use a new pre-filled syringe of Bimzelx 160 mg and repeat steps 2 to 4.
Make sure to select a new injection site for the second injection.

Package leaflet: Information for the user

Bimzelx 160 mg solution for injection in pre-filled pen

bimekizumab

This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4. Contents of this leaflet
  1. What Bimzelx is and what it is used for
  2. What you need to know before using Bimzelx
  3. How to use Bimzelx
  4. Possible side effects
  5. How to store Bimzelx
  6. Contents of the pack and other information Instructions for use

1. What Bimzelx is and what it is used for

What Bimzelx is
Bimzelx contains the active substance bimekizumab.

What Bimzelx is used for
Bimzelx is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis
• Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
• Hidradenitis suppurativa

Plaque psoriasis
Bimzelx is used in adults to treat a skin condition called "plaque psoriasis". Bimzelx reduces symptoms, including pain, itching, and skin scaling.

Psoriatic arthritis
Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes joint inflammation, often accompanied by plaque psoriasis. If active psoriatic arthritis is present, other medicines may be given first. If these medicines are not sufficiently effective or if you are intolerant to them, you will be given Bimzelx either as monotherapy or in combination with another medicine known as methotrexate.

Bimzelx reduces inflammation and may therefore help reduce pain, stiffness, swelling inside and around the joints, psoriatic skin rash, nail damage due to psoriasis, and slow down cartilage and bone damage in the joints affected by the disease. These effects may help control the signs and symptoms of the disease, facilitate normal daily activities, reduce fatigue, and improve quality of life.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
Bimzelx is used to treat adults with an inflammatory disease that primarily affects the spine and causes inflammation of the spinal joints, called axial spondyloarthritis. If the condition is not visible on X-rays, it is referred to as "non-radiographic axial spondyloarthritis"; if patients have visible signs on X-rays, it is called "ankylosing spondylitis" or "radiographic axial spondyloarthritis".

If you have axial spondyloarthritis, you will initially be given other medicines. If you do not respond adequately to these medicines, you will be given Bimzelx to reduce the signs and symptoms of the disease, relieve inflammation, and improve physical function. Bimzelx may help reduce back pain, stiffness, and fatigue, which could assist you in carrying out normal daily activities and improve your quality of life.

Hidradenitis suppurativa
Bimzelx is used in adults to treat a condition called hidradenitis suppurativa (sometimes called inverse acne or Verneuil's disease). Hidradenitis suppurativa is a chronic inflammatory skin disease that causes painful lesions such as painful nodules, abscesses (pockets containing pus), and lesions that may discharge pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas. You will first be given other medicines. If you do not respond sufficiently to these medicines, you will be given Bimzelx.

Bimzelx reduces inflammatory nodules, abscesses (pockets containing pus), and lesions that may discharge pus, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab works by reducing the activity of two proteins called IL-17A and IL-17F, which are involved in the development of inflammation. In inflammatory diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, levels of these proteins are elevated.

2. What you need to know before using Bimzelx

Do not use Bimzelx

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bimzelx if:

• you have an infection or a recurring infection;
• you have recently received or are planning to receive a vaccination. You must not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis)
Stop using Bimzelx and contact your doctor or seek immediate medical help if you notice blood in your stools, abdominal cramps, pain, diarrhoea, or weight loss. These could be signs of a new inflammatory bowel disease or worsening of an existing inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
Be alert for infections and allergic reactions
Bimzelx may rarely cause serious infections. Contact your doctor or seek immediate medical help if you notice any signs indicating a serious infection. These signs are listed in section 4 “Serious unwanted effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek immediate medical help if you notice any signs indicating a serious allergic reaction. These signs may include:

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

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Bimzelx
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. It is preferable to avoid using Bimzelx during pregnancy, as it is not known whether this medicine could harm the unborn baby.
If you are a woman of childbearing age, you must use a contraceptive method during treatment with this medicine and for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or wish to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether you can breastfeed or take Bimzelx.
Driving and using machines
It is unlikely that Bimzelx will affect your ability to drive or operate machinery.
Bimzelx contains polysorbate 80
This medicine contains 0.4 mg of polysorbate 80 per each mL of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Bimzelx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Bimzelx

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Bimzelx is administered and for how long
Plaque psoriasis
The recommended dose, administered via injections under the skin (‘subcutaneous injections’) is as
follows:

• 320 mg (administered with two pre-filled pens containing 160 mg each) at weeks 0, 4, 8, 12, 16;
• from week 16 onwards, you will use 320 mg ( two pre-filled pens containing 160 mg each) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue the injections every 4 weeks starting from week 16. Psoriatic arthritis The recommended dose, administered via injection under the skin (‘subcutaneous injection’) is as follows:
• 160 mg (administered using one pre-filled pen containing 160 mg) every 4 weeks.
• In cases of psoriatic arthritis with coexisting moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust the injections to 160 mg every 4 weeks, depending on joint symptoms.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
The recommended dose, administered via injection under the skin (‘subcutaneous injection’), is as
follows:

• 160 mg (administered with one pre-filled pen containing 160 mg) every 4 weeks. Hidradenitis suppurativa The recommended dose, administered via subcutaneous injections, is as follows:
• 320 mg (administered using two pre-filled pens, each containing 160 mg) every 2 weeks until week 16.
• From week 16 onwards, you will use 320 mg ( two pre-filled pens, each containing 160 mg) every 4 weeks. You and your doctor or nurse will decide whether you can self-administer this medicine. Do not perform the injection of this medicine unless you have been trained by a healthcare professional. A caregiver may also administer the injection after proper training. Before injecting Bimzelx 160 mg solution for injection in a pre-filled pen, carefully read the ‘ Instructions for use ’ at the end of this leaflet. If you use more Bimzelx than you should Inform your doctor if you have received more Bimzelx than you should or if the dose was administered earlier than scheduled. If you forget to use Bimzelx Talk to your doctor if you have forgotten to inject a dose of Bimzelx. If you stop using Bimzelx Talk to your doctor before stopping treatment with Bimzelx. If you stop treatment, symptoms may return. If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects
Contact your doctor or seek immediate medical help if you experience any of the following side effects:
Possible serious infections, signs may include:

• fever, flu-like symptoms, night sweats
• tiredness or shortness of breath, persistent cough
• skin that is hot, red and painful, or painful rash with blistering. Your doctor will assess whether you can continue using Bimzelx. Other side effects Inform 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 blocked nose Common (may affect up to 1 in 10 people)
• oral or throat candidiasis with symptoms such as white or yellow patches; red or sore mouth and pain when swallowing
• fungal skin infections, such as athlete’s foot between the toes
• ear infections
• cold sores (herpes simplex infections)
• stomach upset (gastroenteritis)
• inflamed hair follicles which may resemble pimples
• headache
• itching, dry skin or eczema-like rash sometimes with swelling and redness (dermatitis)
• acne
• redness, pain, swelling or bruising at the injection site
• feeling of tiredness
• fungal infection of the vulvovaginal area (vaginal thrush)

Uncommon (may affect up to 1 in 100 people)

• decrease in white blood cell counts (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• eye discharge with itching, redness and swelling (conjunctivitis)
• blood in stools, cramps and abdominal pain, diarrhoea or weight loss (signs of intestinal problems). Reporting of side effects If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimzelx

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp./EXP". The expiry date refers to the last day of that month.
Store in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
Keep the pre-filled pens in their original packaging to protect the medicine from light.
Bimzelx may be kept outside the refrigerator for up to 25 days, provided it is stored in the outer packaging, at a temperature not exceeding 25 °C and away from direct light. Do not use the pre-filled pen after this period. There is a space on the carton to write the date when it was removed from the refrigerator.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bimzelx contains

• The active substance is bimekizumab. Each pre-filled pen contains 160 mg of bimekizumab in 1 mL of solution.
• The other components are glycine, sodium acetate trihydrate, glacial acetic acid, polysorbate 80, and water for injections.

Description of the appearance of Bimzelx and contents of the pack
Bimzelx is a liquid ranging from clear to slightly opalescent. Its colour may vary from colourless to pale yellowish-brown. It is supplied in a single pre-filled disposable pen. Bimzelx 160 mg solution for injection in pre-filled pen is available in packs containing 1 or 2 pre-filled pens, and in multiple pack presentations consisting of 3 boxes each containing 1 pre-filled pen, or 2 boxes each containing 2 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Brussels, Belgium

Manufacturer
UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine-l’Alleud, Belgium

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

België/Belgique/Belgien
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00

България
UCB Bulgaria EOOD
Tel: +359 (0) 2 962 30 49

Česká republika
UCB s.r.o.
Tel: +420 221 773 411

Danmark
UCB Nordic A/S
Tlf: +45 / 32 46 24 00

Deutschland
UCB Pharma GmbH
Tel: +49 / (0) 2173 48 4848

Eesti
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Soome)

Ελλάδα
UCB Α.Ε.
Τηλ: +30 / 2109974000

España
UCB Pharma, S.A.
Tel: +34 / 91 570 34 44

France
UCB Pharma S.A.
Tél: +33 / (0)1 47 29 44 35

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

Ireland
UCB (Pharma) Ireland Ltd.
Tel: +353 / (0)1-46 37 395

Ísland
UCB Nordic A/S
Sími: +45 / 32 46 24 00

Italia
UCB Pharma S.p.A.
Tel: +39 / 02 300 791

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 056300

Latvija
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Somija)

Lietuva
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Suomi)

Luxembourg/Luxemburg
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00 (Belgique/Belgien)

Magyarország
UCB Magyarország Kft.
Tel: +36-(1) 391 0060

Malta
Pharmasud Ltd.
Tel: +356 / 21 37 64 36

Nederland
UCB Pharma B.V.
Tel: +31 / (0)76-573 11 40

Norge
UCB Nordic A/S
Tlf: +47 / 67 16 5880

Österreich
UCB Pharma GmbH
Tel: +43-(0)1 291 80 00

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z.o.o.
Tel: +48 22 696 99 20

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: +351 21 302 5300

România
UCB Pharma Romania S.R.L.
Tel: +40 21 300 29 04

Slovenija
Medis, d.o.o.
Tel: +386 1 589 69 00

Slovenská republika
UCB s.r.o., organizačná zložka
Tel: +421 (0) 2 5920 2020

Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: +358 9 2514 4221

Sverige
UCB Nordic A/S
Tel: +46 / (0) 40 294 900

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Instructions for use

Read all of the following instructions before using Bimzelx 160 mg solution for injection in
pre-filled pen.
Description of Bimzelx 160 mg in pre-filled pen ( see Figure A ):
A

Viewing
window

Cap
observation

Grip
Needle shield
Important information

• A healthcare professional must show you how to prepare and inject Bimzelx using the 160 mg pre-filled pen. Do not administer the injection to yourself or to anyone else until you have been shown how to inject Bimzelx correctly.
• You and/or the person assisting you must read these Instructions for Use before each use of Bimzelx.
• Contact your healthcare professional if you or the person assisting you has any questions about how to inject Bimzelx correctly.
• Depending on the prescribed dose, you will need to use 1 or 2 pre-filled pens of Bimzelx 160 mg. One pre-filled pen is required for a 160 mg dose, and two pre-filled pens (one after the other) are required for a 320 mg dose.
• Each pre-filled pen is for single use only (single-use). Do not use this medicine and return it to the pharmacy if:
• the expiry date (Exp.) has passed;
• the box seal is broken;
• the pre-filled pen has been dropped or appears damaged;
• the liquid has been frozen (even after thawing). For a more comfortable injection: remove the pre-filled pen(s) of Bimzelx 160 mg from the refrigerator and leave it/them on a flat surface at room temperature for 30–45 minutes before injection.
• Do not heat the pre-filled pen(s) in any other way, for example in a microwave or in warm water.
• Do not shake the pre-filled pen(s).
• Do not remove the cap from the pre-filled pen(s) until you are ready to perform the injection.

Follow these instructions every time you use Bimzelx.
Step 1: Prepare for injection(s)
Depending on the prescribed dose, place the following items on a flat, well-lit work surface,
such as a table:

• 1 or 2 pre-filled pens of Bimzelx 160 mg
  You will also need (not included in the pack):
• 1 or 2 alcohol swabs
• 1 or 2 clean cotton balls
• 1 sharps disposal container. See “Disposal of used Bimzelx pre-filled pen” at the end of these Instructions for Use.
  Step 2: Choose the injection site and prepare for injection
  2a: Choose the injection site
• The sites you can choose for injection are:
• stomach (abdomen) or thigh ( see Figure B );
• back of the upper arm ( see Figure C ). Bimzelx may be injected into the back of the upper arm only by a healthcare professional or another person.

B C

abdomen or
thigh
back of arm

• Do not inject into areas where the skin is tender, bruised, red, flaky, hard, or areas with scars or stretch marks.
• Do not inject within 5 cm of the navel.
• If a second injection is required based on the prescribed dose (320 mg), use a different injection site for the second injection. Do not use the same site for two consecutive injections.
  2b: Wash your hands thoroughly with soap and water and dry them with a clean towel
  2c: Prepare the skin
• Clean the injection site with an alcohol swab. Allow the area to dry completely. Do not touch the cleaned area again before the injection.

2d: Check the pre-filled pen (see Figure D)

• Make sure the name Bimzelx and the expiry date are visible on the label.
• Check the medicine through the viewing window. The medicine should be from clear to slightly opalescent and free from particles. Its colour may vary from colourless to pale yellow-brown. You may see air bubbles in the liquid: this is normal.
• Do not use the Bimzelx pre-filled pen if the medicine is cloudy, discoloured, or contains particles.

D

Viewing
window
Expiry
date
Step 3: Inject Bimzelx
3a: Remove the cap from the pre-filled pen

• With one hand, hold the pre-filled pen firmly by the grip. With the other hand, remove the cap from the pre-filled pen ( see Figure E ). The needle is now exposed, even if you cannot see it.
• Do not touch the needle shield and do not replace the cap. Otherwise, you may activate the pre-filled pen and accidentally prick yourself.

E

3b: Hold the pre-filled pen at a 90-degree angle to the clean injection site (see Figure F)

F

90°
3c: Press the pre-filled pen fully against the skin, then press it firmly down against the skin
You will hear a click. The injection starts at the first “click” ( see Figure G ).
Do not remove the pre-filled pen from the skin.

G

Click
3d: Keep holding the pre-filled pen in place, pressing it firmly against the skin.

• You will hear a second “click” within 15 seconds of the first.
• The second click indicates that all the medicine has been injected and that the Bimzelx injection is complete. You should see the yellow indicator fill the viewing window ( see Figure H ).

H

15s
Click
3e: Remove the pre-filled pen by gently lifting it away from the skin. The needle shield will
automatically cover the needle

• Press a dry cotton ball on the injection site for a few seconds. Do not rub the injection site. You may see slight bleeding or a drop of liquid: this is normal. You may cover the injection site with a small plaster, if needed.

Step 4: Disposal of used Bimzelx pre-filled pen
Place the used pre-filled pen into a sharps disposal container immediately after use ( see Figure I ).

I

If a second injection is prescribed by your doctor, use a new Bimzelx 160 mg pre-filled pen and
repeat steps 2 to 4.
Make sure to select a new injection site for the second injection.

Package leaflet: Information for the user

Bimzelx 320 mg solution for injection in pre-filled syringe

bimekizumab

This medicinal product is under additional monitoring. This will allow rapid identification of
new safety information. You can help by reporting any side effects you experience while taking
this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
  1. What Bimzelx is and what it is used for
  2. What you need to know before using Bimzelx
  3. How to use Bimzelx
  4. Possible side effects
  5. How to store Bimzelx
  6. Contents of the pack and other information Instructions for use

1. What is Bimzelx and what is it used for

What is Bimzelx
Bimzelx contains the active substance bimekizumab.
What is Bimzelx used for
Bimzelx is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis
• Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
• Hidradenitis suppurativa

Plaque psoriasis
Bimzelx is used in adults to treat a skin condition called "plaque psoriasis". Bimzelx reduces symptoms including pain, itching, and skin scaling.

Psoriatic arthritis
Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes joint inflammation, often accompanied by plaque psoriasis. If active psoriatic arthritis is present, other medicines may be given first. If these medicines are not effective enough, or if you are intolerant to them, you will be given Bimzelx as monotherapy or in combination with another medicine called methotrexate.

Bimzelx reduces inflammation and therefore helps reduce pain, stiffness, swelling within and around the joints, psoriatic skin rash, nail damage due to psoriasis, and slows down damage to cartilage and bone in the affected joints. These effects may help control the signs and symptoms of the disease, make everyday activities easier, reduce fatigue, and improve quality of life.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
Bimzelx is used to treat adults with an inflammatory disease that primarily affects the spine and causes inflammation of the spinal joints, called axial spondyloarthritis. If the condition is not visible on X-rays, it is referred to as "non-radiographic axial spondyloarthritis"; if patients have visible X-ray signs, it is called "ankylosing spondylitis" or "radiographic axial spondyloarthritis".

If you have axial spondyloarthritis, you will initially be given other medicines. If you do not respond adequately to these medicines, you will be given Bimzelx to reduce the signs and symptoms of the disease, reduce inflammation, and improve physical function. Bimzelx may help reduce back pain, stiffness, and fatigue, which could help you carry out normal daily activities and improve your quality of life.

Hidradenitis suppurativa
Bimzelx is used in adults to treat a condition called hidradenitis suppurativa (sometimes called inverse acne or Verneuil's disease). Hidradenitis suppurativa is a chronic inflammatory skin disease that causes painful lesions such as tender nodules, abscesses (pockets containing pus), and draining wounds. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in the affected areas. You will first be given other medicines. If you do not respond sufficiently to these medicines, you will be given Bimzelx.

Bimzelx reduces inflammatory nodules, abscesses (pockets containing pus), draining wounds, and the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab works by reducing the activity of two proteins called IL-17A and IL-17F, which are involved in the development of inflammation. In inflammatory diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, levels of these proteins are elevated.

2. What you need to know before using Bimzelx

Do not use Bimzelx

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bimzelx if:

• you have an infection or a recurring infection;
• you have recently received or are planning to receive a vaccination. You must not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis)
Stop using Bimzelx and contact your doctor or seek immediate medical attention if you notice blood in your stools, abdominal cramps, pain, diarrhoea, or weight loss. These could be signs of a new inflammatory bowel disease or worsening of an existing inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
Be alert for infections and allergic reactions
Bimzelx may rarely cause serious infections. Contact your doctor or seek immediate medical attention if you notice any signs indicating a serious infection. These signs are listed in section 4 “Serious unwanted effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek immediate medical attention if you notice any signs indicating a severe allergic reaction. These signs may include:

• difficulty breathing or swallowing
• low blood pressure, which may cause dizziness or fainting
• swelling of the face, lips, tongue, or throat
• intense skin itching, with a red rash or raised bumps.

Children and adolescents
Do not administer this medicine to children or adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Bimzelx
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. It is preferable to avoid using Bimzelx during pregnancy, as it is unknown whether this medicine could harm the unborn baby.
If you are a woman of childbearing potential, you must use a contraceptive method during treatment with this medicine and for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or intend to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether you can breastfeed or take Bimzelx.
Driving and using machines
It is unlikely that Bimzelx will affect your ability to drive or operate machinery.
Bimzelx contains polysorbate 80
This medicine contains 0.4 mg of polysorbate 80 per mL of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Bimzelx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Bimzelx

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dosage and duration of Bimzelx treatment

Plaque psoriasis
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 320 mg (administered with one pre-filled syringe containing 320 mg) at weeks 0, 4, 8, 12, and 16;
• from week 16 onwards, you will use 320 mg (one pre-filled syringe containing 320 mg) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue injections every 4 weeks starting from week 16.

Psoriatic arthritis
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 160 mg every 4 weeks.
• In cases of psoriatic arthritis with moderate to severe coexisting plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust the injections to 160 mg every 4 weeks, depending on joint symptoms. Other pharmaceutical forms/concentrations are available for administration of the 160 mg dose.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 160 mg every 4 weeks. Other pharmaceutical forms/concentrations are available for administration of the 160 mg dose.

Hidradenitis suppurativa
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 320 mg (administered with one pre-filled syringe containing 320 mg) every 2 weeks up to week 16.
• From week 16 onwards, you will use 320 mg (one pre-filled syringe containing 320 mg) every 4 weeks.

You and your doctor or nurse will decide whether you can self-administer this medicine. Do not perform the injection yourself unless you have been trained by a healthcare professional. A caregiver who looks after you may also administer the injection after proper training.

Before injecting Bimzelx 320 mg solution for injection in a pre-filled syringe yourself, carefully read the ‘Instructions for use’ at the end of this leaflet.

If you use more Bimzelx than you should
Inform your doctor if you have received more Bimzelx than you should, or if the dose was administered earlier than scheduled.

If you forget to use Bimzelx
Talk to your doctor if you have forgotten to inject a dose of Bimzelx.

If you stop using Bimzelx
Talk to your doctor before stopping treatment with Bimzelx. If you stop treatment, your symptoms may return.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Contact your doctor or seek immediate medical assistance if you experience any of the following side effects.
Possible serious infections, signs may include:

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

Your doctor will assess whether you can continue using Bimzelx.
Other side effects
Inform 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 blocked nose
  Common (may affect up to 1 in 10 people)
• oral or throat candidiasis with symptoms such as white or yellow patches; red or sore mouth and pain when swallowing
• fungal skin infections, such as athlete’s foot between the toes
• ear infections
• cold sores (herpes simplex infections)
• stomach upset (gastroenteritis)
• inflamed hair follicles which may resemble pimples
• headache
• itching, dry skin or eczema-like rash sometimes with swelling and redness (dermatitis)
• acne
• redness, pain or swelling and bruising at the injection site
• feeling of tiredness
• fungal infection of the vulvovaginal area (vaginal thrush)
  Uncommon (may affect up to 1 in 100 people)
• decrease in white blood cell counts (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• eye discharge with itching, redness and swelling (conjunctivitis)
• blood in the stool, abdominal cramps and pain, diarrhoea or weight loss (signs of intestinal problems). Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimzelx

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 and the carton after
"Exp./EXP". The expiry date refers to the last day of that month.
Store in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
Keep the pre-filled syringes in their original packaging to protect the medicine from light.
Bimzelx may be kept outside the refrigerator for up to 25 days, provided it is stored in the
outer packaging, at a temperature not exceeding 25 °C and away from direct light. Do not use the
pre-filled syringe after this period. There is a space on the carton to write the date when it was
removed from the refrigerator.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bimzelx contains

• The active substance is bimekizumab. Each pre-filled syringe contains 320 mg of bimekizumab in 2 mL of solution.
• The other components are glycine, sodium acetate trihydrate, glacial acetic acid, polysorbate 80, and water for injections.

Description of the appearance of Bimzelx and package contents

Bimzelx is a liquid ranging from clear to slightly opalescent. Its colour may vary from colourless to pale yellowish-brown. It is supplied in a single pre-filled, single-use syringe with a needle cap. Bimzelx 320 mg solution for injection in pre-filled syringe is available in packs containing 1 pre-filled syringe and in multiple packs consisting of 3 boxes, each containing 1 pre-filled syringe. Not all pack sizes may be marketed.

Marketing Authorisation Holder

UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Brussels, Belgium

Manufacturer

UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine-l’Alleud, Belgium

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

België/Belgique/Belgien
Lietuva
UCB Pharma S.A./NV
UCB Pharma Oy Finland
Tél/Tel: +32 / (0)2 559 92 00
Tel: +358 9 2514 4221 (Suomija)

България
Luxembourg/Luxemburg
UCB Bulgaria EOOD
Tel: +359 (0) 2 962 30 49
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
Magyarország
UCB s.r.o.
Tel: +420 221 773 411
UCB Magyarország Kft.
Tel.: +36-(1) 391 0060

Danmark
Malta
UCB Nordic A/S
Tlf.: +45 / 32 46 24 00
Pharmasud Ltd.
Tel: +356 / 21 37 64 36

Deutschland
Nederland
UCB Pharma GmbH
Tel: +49 /(0) 2173 48 4848
UCB Pharma B.V.
Tel: +31 / (0)76-573 11 40

Eesti
Norge
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Soome)
UCB Nordic A/S
Tlf: +47 / 67 16 5880

Ελλάδα
Österreich
UCB A.E.
Τηλ: +30 / 2109974000
UCB Pharma GmbH
Tel: +43-(0)1 291 80 00

España
Polska
UCB Pharma, S.A.
Tel: +34 / 91 570 34 44
UCB Pharma Sp. z o.o. / VEDIM Sp. z.o.o.
Tel.: +48 22 696 99 20

France
Portugal
UCB Pharma S.A.
Tél: +33 / (0)1 47 29 44 35
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: +351 21 302 5300

Hrvatska
România
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46
UCB Pharma Romania S.R.L.
Tel: +40 21 300 29 04

Ireland
Slovenija
UCB (Pharma) Ireland Ltd.
Tel: +353 / (0)1-46 37 395
Medis, d.o.o.
Tel: +386 1 589 69 00

Ísland
Slovenská republika
UCB Nordic A/S
Sími: +45 / 32 46 24 00
UCB s.r.o., organizačná zložka
Tel: +421 (0) 2 5920 2020

Italia
Suomi/Finland
UCB Pharma S.p.A.
Tel: +39 / 02 300 791
UCB Pharma Oy Finland
Puh/Tel: +358 9 2514 4221

Κύπρος
Sverige
Lifepharma (Z.A.M.) Ltd
Tel: +357 22 056300
UCB Nordic A/S
Tel: +46 / (0) 40 294 900

Latvija
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Somija)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Instructions for use

Read all of the following instructions before using Bimzelx 320 mg solution for injection in
pre-filled syringe.
Description of Bimzelx 320 mg in pre-filled syringe ( see Figure A ):

Important information

• A healthcare provider must show you how to prepare and inject Bimzelx using the 320 mg pre-filled syringe. Do not inject yourself or anyone else until you have been shown the correct way to inject Bimzelx.
• You and/or the person assisting you must read these Instructions for Use before each use of Bimzelx.
• Contact your healthcare provider if you or the person assisting you has any questions about how to correctly inject Bimzelx.
• Each pre-filled syringe is for single use only (single-use).
• The 320 mg pre-filled syringe is equipped with a safety needle feature that automatically covers the needle after the injection is complete. The needle safety feature helps prevent needlestick injuries to anyone handling the pre-filled syringe after injection. Do not use this medicine and return it to the pharmacy if:
• the expiry date (Exp./EXP) has passed;
• the box seal is broken;
• the pre-filled syringe has been dropped or appears damaged;
• the liquid has been frozen (even after thawing).

For a more comfortable injection: remove the 320 mg Bimzelx pre-filled syringe from
the refrigerator and leave it in the original cardboard box on a flat surface at room temperature
for 30–45 minutes before administering the injection.

• Do not heat the syringe(s) in any other way, for example, in a microwave or in hot water.
• Do not shake the pre-filled syringe.
• Do not remove the needle cap from the pre-filled syringe until you are ready to administer the injection.

Follow these instructions every time you use Bimzelx.
Step 1: Prepare for injection
Place the following items on a flat, well-lit work surface, such as a table:

• 1 pre-filled syringe of Bimzelx 320 mg
  The following items will also be needed (not included in the pack):
• 1 alcohol wipe
• 1 clean cotton ball
• 1 sharps disposal container. See “Disposal of used Bimzelx pre-filled syringe” at the end of these Instructions for Use. Step 2: Choose the injection site and prepare for injection 2a: Choose the injection site
• The areas you can choose for injection are:
• stomach (abdomen) or thigh ( see Figure B );
• the back of the upper arm ( see Figure C ). Bimzelx may be injected into the back of the upper arm only by a healthcare provider or another person.

• Do not inject into areas where the skin is tender, bruised, red, scaly, hard, or areas with scars or stretch marks.
• Do not inject within 5 cm of the navel.
• Choose a different injection site each time you administer an injection. 2b: Wash your hands thoroughly with soap and water and dry them with a clean towel 2c: Prepare the skin
• Clean the injection site with an alcohol wipe. Allow the area to dry completely. Do not touch the cleaned area again before the injection.

2d: Check the pre-filled syringe (see Figure D)

• Make sure the name Bimzelx and the expiry date are visible on the label.
• Check the medicine through the viewing window. The medicine should be from clear to slightly opalescent and free from particles. Its colour may vary from colourless to pale yellowish-brown. You may see air bubbles in the liquid: this is normal.
• Do not use the Bimzelx pre-filled syringe if the medicine is cloudy, discoloured, or contains particles.

Step 3: Inject Bimzelx
3a: Remove the needle cap from the pre-filled syringe

• Hold the pre-filled syringe by the finger grip with one hand. With the other hand, remove the needle cap from the pre-filled syringe ( see Figure E ). You may see a drop of liquid at the tip of the needle; this is normal.
• Do not touch the needle and do not let the needle touch any surface.
• Do not press the plunger while removing the cap. If you accidentally remove the plunger rod, discard the pre-filled syringe into the sharps disposal container and take a new one.
• Do not replace the needle cap. This may damage the needle or cause a needlestick injury.

3b: With one hand, gently pinch and hold a fold of the cleaned skin for injection. With the other hand, insert the needle into the skin at an angle of approximately 45 degrees

• Push the needle fully in. Then gently release the skin. Make sure the needle is in place ( see Figure F ).

3c: Press the plunger head all the way down until all the medicine has been injected
(see Figure G)

• All the medicine will have been injected when you can no longer push the plunger head any further ( see Figure H ).

3d: Remove your thumb from the plunger head (see Figure I). The needle will automatically retract
and lock in place

• Press a dry cotton ball on the injection site for a few seconds. Do not rub the injection site. You may see slight bleeding or a drop of liquid: this is normal. You may cover the injection site with a small plaster if needed. Step 4: Dispose of the used Bimzelx pre-filled syringe Immediately after use, place the used pre-filled syringe into a sharps disposal container ( see Figure J ).

Package leaflet: information for the user

Bimzelx 320 mg solution for injection in pre-filled pen

bimekizumab

This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4. Contents of this leaflet
  1. What Bimzelx is and what it is used for
  2. What you need to know before using Bimzelx
  3. How to use Bimzelx
  4. Possible side effects
  5. How to store Bimzelx
  6. Contents of the pack and other information Instructions for use

1. What is Bimzelx and what is it used for

What is Bimzelx
Bimzelx contains the active substance bimekizumab.
What Bimzelx is used for
Bimzelx is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis
• Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
• Hidradenitis suppurativa

Plaque psoriasis
Bimzelx is used in adults for the treatment of a skin condition called "plaque psoriasis". Bimzelx reduces symptoms including pain, itching, and skin scaling.

Psoriatic arthritis
Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflammation of the joints, often accompanied by plaque psoriasis. If active psoriatic arthritis is present, other medicines may be given first. If these medicines are not sufficiently effective or if you are intolerant to them, you will be given Bimzelx either as monotherapy or in combination with another medicine known as methotrexate.
Bimzelx reduces inflammation and can therefore help reduce pain, stiffness, swelling inside and around the joints, psoriatic skin rash, nail damage due to psoriasis, and slow down cartilage and bone damage in the joints affected by the disease. These effects may help control the signs and symptoms of the disease, facilitate normal daily activities, reduce fatigue, and improve quality of life.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
Bimzelx is used to treat adults with an inflammatory disease that primarily affects the spine and causes inflammation of the spinal joints, called axial spondyloarthritis. If the condition is not visible on X-rays, it is referred to as "non-radiographic axial spondyloarthritis"; if patients have visible radiographic signs, it is referred to as "ankylosing spondylitis" or "radiographic axial spondyloarthritis".
If you have axial spondyloarthritis, you will initially be given other medicines. If you do not respond adequately to these medicines, you will be given Bimzelx to reduce the signs and symptoms of the disease, alleviate inflammation, and improve physical function. Bimzelx may help reduce back pain, stiffness, and fatigue, which could assist you in performing normal daily activities and improve your quality of life.

Hidradenitis suppurativa
Bimzelx is used in adults to treat a condition called hidradenitis suppurativa (sometimes called acne inversa or Verneuil's disease). Hidradenitis suppurativa is a chronic inflammatory skin disease that causes painful lesions such as tender nodules, abscesses (pockets containing pus), and lesions that may discharge pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas. You will first be given other medicines. If you do not respond sufficiently to these medicines, you will be given Bimzelx.
Bimzelx reduces inflammatory nodules, abscesses (pockets containing pus), and lesions that may discharge pus, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab works by reducing the activity of two proteins called IL-17A and IL-17F, which are involved in the development of inflammation. In inflammatory diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, levels of these proteins are elevated.

2. What you need to know before using Bimzelx

Do not use Bimzelx

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bimzelx if:

• you have an infection or a recurring infection;
• you have recently received or are planning to receive a vaccination. You must not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis)
Stop using Bimzelx and contact your doctor or seek immediate medical help if you notice blood in your stool, abdominal cramps, pain, diarrhoea, or weight loss. These could be signs of a new inflammatory bowel disease or worsening of existing inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
Be alert for infections and allergic reactions
Bimzelx may rarely cause serious infections. Contact your doctor or seek immediate medical help if you notice any signs indicating a serious infection. These signs are listed in section 4 “Serious unwanted effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek immediate medical help if you notice any signs of a serious allergic reaction. These signs may include:

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

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and Bimzelx
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. It is preferable to avoid using Bimzelx during pregnancy. This is because it is not known whether this medicine could harm the unborn baby.
If you are a woman of childbearing age, you must use contraception during treatment with this medicine and for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or planning to breastfeed, ask your doctor for advice before using this medicine. You and your doctor must decide whether you can breastfeed or take Bimzelx.

Driving and using machines
It is unlikely that Bimzelx will affect your ability to drive or use machines.

Bimzelx contains polysorbate 80
This medicine contains 0.4 mg of polysorbate 80 per mL of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Bimzelx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Bimzelx

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Dose and duration of Bimzelx treatment

Plaque psoriasis
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’) is as follows:

• 320 mg (administered using one pre-filled pen containing 320 mg) at weeks 0, 4, 8, 12, and 16;
• from week 16 onwards, you will use 320 mg (one pre-filled pen containing 320 mg) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue injections every 4 weeks starting from week 16.

Psoriatic arthritis
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 160 mg every 4 weeks.
• In cases of psoriatic arthritis with moderate to severe coexisting plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust the injections to 160 mg every 4 weeks, depending on joint symptoms. Other pharmaceutical forms/concentrations are available for administration of the 160 mg dose.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 160 mg every 4 weeks. Other pharmaceutical forms/concentrations are available for administration of the 160 mg dose.

Hidradenitis suppurativa
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is as follows:

• 320 mg (administered using one pre-filled pen containing 320 mg) every 2 weeks up to week 16.
• From week 16 onwards, you will use 320 mg (one pre-filled pen containing 320 mg) every 4 weeks.

You and your doctor or nurse will decide whether you can self-administer this medicine. Do not perform the injection of this medicine unless you have been trained by a healthcare professional. A caregiver may also administer the injection for you after proper training.

Before injecting Bimzelx 320 mg solution for injection in a pre-filled pen, carefully read the ‘Instructions for use’ at the end of this leaflet.

If you use more Bimzelx than you should
Inform your doctor if you have received more Bimzelx than prescribed or if the dose was administered earlier than scheduled.

If you forget to use Bimzelx
Talk to your doctor if you have forgotten to inject a dose of Bimzelx.

If you stop using Bimzelx
Talk to your doctor before stopping treatment with Bimzelx. If you stop treatment, symptoms may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Contact your doctor or seek immediate medical help if you experience any of the following side effects:
Possible serious infections, signs may include:

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

Your doctor will assess whether you can continue using Bimzelx.
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 blocked nose

Common (may affect up to 1 in 10 people)

• oral or throat candidiasis with symptoms such as white or yellow patches; red or sore mouth and pain when swallowing
• fungal skin infections, such as athlete’s foot between the toes
• ear infections
• cold sores (herpes simplex infections)
• stomach upset (gastroenteritis)
• inflamed hair follicles which may resemble pimples
• headache
• itching, dry skin or eczema-like rash sometimes with swelling and redness (dermatitis)
• acne
• redness, pain or swelling and bruising at the injection site
• feeling of tiredness
• fungal infection of the vulvovaginal area (vaginal thrush)

Uncommon (may affect up to 1 in 100 people)

• decrease in white blood cell counts (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• eye discharge with itching, redness and swelling (conjunctivitis)
• blood in the stool, cramps and abdominal pain, diarrhoea or weight loss (signs of intestinal problems)

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

5. How to store Bimzelx

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "Exp./EXP". The expiry date refers to the last day of that month.
Store in the refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
Keep the pre-filled pens in their original packaging to protect the medicine from light.
Bimzelx may be kept outside the refrigerator for up to 25 days, provided it is stored in the outer packaging, at a temperature not exceeding 25 °C and away from direct light. Do not use the pre-filled pen after this period. The carton includes a space to write the date when it was removed from the refrigerator.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Bimzelx contains

• The active substance is bimekizumab. Each pre-filled pen contains 320 mg of bimekizumab in 2 mL of solution.
• The other ingredients are glycine, sodium acetate trihydrate, glacial acetic acid, polysorbate 80 and water for injections.

Description of the appearance of Bimzelx and contents of the pack
Bimzelx is a liquid ranging from clear to slightly opalescent. Its colour may vary from colourless to pale yellowish-brown. It is supplied in a single pre-filled disposable pen. Bimzelx 320 mg solution for injection in pre-filled pen is available in packs containing 1 pre-filled pen and in multiple packs consisting of 3 cartons, each containing 1 pre-filled pen. Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Brussels, Belgium

Manufacturer
UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine-l’Alleud, Belgium

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

België/Belgique/Belgien
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00

България (Bulgaria)
UCB Bulgaria EOOD
Tel: +359 (0)2 962 30 49

Česká republika (Czech Republic)
UCB s.r.o.
Tel: +420 221 773 411

Danmark (Denmark)
UCB Nordic A/S
Tlf: +45 / 32 46 24 00

Deutschland (Germany)
UCB Pharma GmbH
Tel: +49 / (0)2173 48 4848

Eesti (Estonia)
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Soome)

Ελλάδα (Greece)
UCB Α.Ε.
Τηλ: +30 / 2109974000

España (Spain)
UCB Pharma, S.A.
Tel: +34 / 91 570 34 44

France
UCB Pharma S.A.
Tél: +33 / (0)1 47 29 44 35

Hrvatska (Croatia)
Medis Adria d.o.o.
Tel: +385 (0)1 230 34 46

Ireland
UCB (Pharma) Ireland Ltd.
Tel: +353 / (0)1-46 37 395

Ísland (Iceland)
UCB Nordic A/S
Sími: +45 / 32 46 24 00

Italia (Italy)
UCB Pharma S.p.A.
Tel: +39 / 02 300 791

Κύπρος (Cyprus)
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 056300

Latvija (Latvia)
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Somija)

Lietuva (Lithuania)
UCB Pharma Oy Finland
Tel: +358 9 2514 4221 (Suomi)

Luxembourg/Luxemburg
UCB Pharma S.A./NV
Tél/Tel: +32 / (0)2 559 92 00 (Belgique/Belgien)

Magyarország (Hungary)
UCB Magyarország Kft.
Tel: +36-(1) 391 0060

Malta
Pharmasud Ltd.
Tel: +356 / 21 37 64 36

Nederland (Netherlands)
UCB Pharma B.V.
Tel: +31 / (0)76-573 11 40

Norge (Norway)
UCB Nordic A/S
Tlf: +47 / 67 16 5880

Österreich (Austria)
UCB Pharma GmbH
Tel: +43-(0)1 291 80 00

Polska (Poland)
UCB Pharma Sp. z o.o. / VEDIM Sp. z.o.o.
Tel: +48 22 696 99 20

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: +351 21 302 5300

România (Romania)
UCB Pharma Romania S.R.L.
Tel: +40 21 300 29 04

Slovenija (Slovenia)
Medis, d.o.o.
Tel: +386 1 589 69 00

Slovenská republika (Slovakia)
UCB s.r.o., organizačná zložka
Tel: +421 (0)2 5920 2020

Suomi/Finland (Finland)
UCB Pharma Oy Finland
Puh/Tel: +358 9 2514 4221

Sverige (Sweden)
UCB Nordic A/S
Tel: +46 / (0)40 294 900

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Instructions for use

Read all of the following instructions before using Bimzelx 320 mg solution for injection in
pre-filled pen.
Description of Bimzelx 320 mg in pre-filled pen ( see Figure A ):

Important information

• A healthcare professional must show you how to prepare and inject Bimzelx using the 320 mg pre-filled pen. Do not inject yourself or anyone else until you have been shown how to inject Bimzelx correctly.
• You and/or the person assisting you must read these Instructions for Use before each use of Bimzelx.
• Contact your healthcare professional if you or the person assisting you has any questions about how to inject Bimzelx correctly.
• Each pre-filled pen is for single use only (disposable). Do not use this medicine and return it to the pharmacy if:
• the expiry date (Exp./EXP) has passed;
• the carton seal is broken;
• the pre-filled pen has been dropped or appears damaged;
• the liquid has been frozen (even after thawing). For a more comfortable injection: remove the 320 mg pre-filled pen from the refrigerator and leave it in its original carton on a flat surface at room temperature for 30–45 minutes before injection.
• Do not heat the pre-filled pen/pen(s) in any other way, for example, in a microwave or in hot water.
• Do not shake the pre-filled pen.
• Do not remove the pen cap until you are ready to perform the injection.

Follow these instructions every time you use Bimzelx.
Step 1: Prepare for injection
Place the following items on a flat, well-lit work surface, such as a table:

• 1 pre-filled pen of Bimzelx 320 mg
  The following will also be needed (not included in the pack):
• 1 alcohol swab
• 1 clean cotton ball
• 1 sharps disposal container. See “Disposal of used Bimzelx pre-filled pen” at the end of these Instructions for Use. Step 2: Choose the injection site and prepare for injection 2a: Choose the injection site
• The areas you can choose for injection are:
• stomach (abdomen) or thigh ( see Figure B );
• upper outer arm ( see Figure C ). Bimzelx may be injected into the upper outer arm only by a healthcare professional or another person.

• Do not inject into areas where the skin is tender, bruised, red, scaly, hard, or into areas with scars or stretch marks.
• Do not inject within 5 cm of the navel.
• Choose a different injection site each time you give an injection. 2b: Wash your hands thoroughly with soap and water and dry them with a clean towel 2c: Prepare the skin
• Clean the injection site with an alcohol swab. Allow the area to dry completely. Do not touch the cleaned area again before the injection.

2d: Check the pre-filled pen (see Figure D)

• Make sure the name Bimzelx and the expiry date are visible on the label.
• Check the medicine through the viewing window. The medicine should be from clear to slightly opalescent and free from particles. Its colour may vary from colourless to pale yellow-brown. You may see air bubbles in the liquid: this is normal.
• Do not use the Bimzelx pre-filled pen if the medicine is cloudy, discoloured, or contains particles.

Step 3: Inject Bimzelx
3a: Remove the cap from the pre-filled pen

• Hold the pre-filled pen firmly by the grip with one hand. With the other hand, remove the cap from the pre-filled pen ( see Figure E ). The needle is now exposed, even if you cannot see it.
• Do not touch the needle shield and do not replace the cap. Otherwise, you may activate the pre-filled pen and accidentally prick yourself.

3b: Hold the pre-filled pen at a 90-degree angle to the clean injection site (see
Figure F)

3c: Press the pre-filled pen fully against the skin, then press it firmly down against the skin
You will hear a click. The injection starts at the first “click” ( see Figure G ).
Do not remove the pre-filled pen from the skin.

3d: Continue holding the pre-filled pen in place, pressing it firmly against the skin.
20 seconds are required to receive the full dose.

• You will hear a second “click”, indicating that the injection is almost complete. You will see the yellow indicator fill the viewing window ( see Figure H ).

• After the second click, continue to hold the pre-filled pen pressed down for an additional 5 seconds (count slowly to 5). This ensures the full dose is delivered (see Figure I).

3e: Remove the pre-filled pen by gently lifting it away from the skin. The needle shield will automatically cover the needle

• Press a dry cotton ball on the injection site for a few seconds. Do not rub the injection site. You may see slight bleeding or a drop of liquid: this is normal. You may cover the injection site with a small plaster if needed.

Step 4: Disposal of used Bimzelx pre-filled pen
Place the used pre-filled pen into a sharps disposal container immediately after use ( see Figure J ).