BIMZELX 160 mg Roztwór Do Wstrzykiwań

Treść ulotki

1. Bimzelx 160 mg injectable solution in pre-filled syringe
   1. What is Bimzelx and what is it 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
2. Bimzelx 160 mg injectable solution in a pre-filled pen
   1. What is Bimzelx and what is it 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
3. Bimzelx 320 mg injectable solution in pre-filled syringe
   1. What is Bimzelx and what is it 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
4. Bimzelx 320 mg injectable solution in a pre-filled pen
   1. What is Bimzelx and what is it 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. Content of the pack and other information

Bimzelx 160 mg injectable solution in pre-filled syringe

bimekizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 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 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 ingredient bimekizumab.

What is Bimzelx used for
Bimzelx is used for the treatment of 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 the symptoms, including pain, itching and scaling of the skin.
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. In the case of active psoriatic arthritis, other medicines may be given first. If these medicines are not effective enough, or in case of intolerance, you will be given Bimzelx as monotherapy or in combination with another medicine, known as methotrexate.
Bimzelx reduces inflammation and may, therefore, help to reduce pain, stiffness, swelling inside and around the joints, psoriatic skin rash, nail damage due to psoriasis and to slow down damage to the cartilage and bones of the joints involved in the disease.
These effects can help to control the signs and symptoms of the disease, to facilitate normal daily activities, to reduce fatigue and to improve the quality of life.
Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
Bimzelx is used for the treatment of 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 present with visible radiographic signs, it is referred to as “ankylosing spondylitis” or “radiographic axial spondyloarthritis”.
If you suffer from axial spondyloarthritis, you will initially be given other medicines. If you do not respond adequately to these medicines, you will receive Bimzelx in order to reduce the signs and symptoms of the disease, alleviate inflammation and improve physical function. Bimzelx may help to reduce back pain, stiffness and fatigue, which may help 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 inverse acne or Verneuil's disease). Hidradenitis suppurativa is a chronic inflammatory skin disease that causes painful lesions such as painful nodules, abscesses (pus-filled sacs), and lesions from which pus may leak. It most commonly affects specific areas of the skin such as the area under the breast, armpits, inner thighs, groin and buttocks. Scars can also form in the affected areas. Other medicines will be given to you first. If you do not respond well enough to these medicines, you will be given Bimzelx.
Bimzelx reduces inflammatory nodules, abscesses (pus-filled sacs), and lesions from which pus may leak, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active ingredient contained in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimzelx 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, higher levels of these proteins are present.

2. What you need to know before using Bimzelx

Do not use Bimzelx

• if you are allergic to bimekizumab or 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 an infection that keeps coming back;
• you have recently had a vaccination or are planning to have one. You should not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had an 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 may be signs of
a new inflammatory bowel disease or worsening of an inflammatory bowel
disease (Crohn’s disease or ulcerative colitis).

Pay attention to any infections and allergic reactions
Bimzelx can rarely cause serious infections. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any sign indicating a
serious infection. These signs are listed in section 4 “Serious side effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any sign indicating a
serious allergic reaction. These signs may include:

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

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because 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, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of
Bimzelx during pregnancy. 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 contraception during use of this medicine
and for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or plan to do so, ask your doctor for advice before using this medicine.
You and your doctor should decide together whether you can breastfeed or take Bimzelx.

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

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 following exactly the instructions of 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 by injections under the skin (‘subcutaneous injections’), is the
following:

• 320 mg (administered with twoprefilled syringes containing 160 mg each) at weeks 0, 4, 8, 12, 16;
• from week 16, you will use 320 mg (twoprefilled 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 by subcutaneous injection (‘subcutaneous injection’), is the
following:

• 160 mg (administered using oneprefilled syringe containing 160 mg) every 4 weeks.
• In case of psoriatic arthritis with coexisting moderate to severe plaque psoriasis, the recommended dosage 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 your joint symptoms.

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

• 160 mg (administered with oneprefilled syringe containing 160 mg) every 4 weeks.

Hidradenitis suppurativa
The recommended dose, administered by subcutaneous injections (‘subcutaneous injections’), is the
following:

• 320 mg (administered using twoprefilled syringes, containing 160 mg each) every 2 weeks up to week 16.
• From week 16, you will use 320 mg (twoprefilled syringes, containing 160 mg each) every 4 weeks.

You and your doctor or nurse will decide whether you will be able to self-administer this medicine. Do not
administer the injection of this medicine unless you have been instructed by a healthcare professional. Anyone
caring for you can also administer the injection to give you the medicine, after being
trained.
Before self-injecting Bimzelx 160 mg injectable solution in a prefilled syringe, read

If you use more Bimzelx than you should
Inform your doctor if you have received more Bimzelx than you should or the dose was administered before
when it was due.

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, the
symptoms may return.
If you have any questions about using 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
See a doctor or get immediatemedical help if you get any of the following side effects:
Possible serious infections, the signs can include:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that doesn't go away
• skin that is warm, red and painful, or a painful rash with blisters.

Your doctor will assess whether you can continue to use Bimzelx.

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 airway infections with symptoms such as sore throat and stuffy nose

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• low levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• blood in your stools, cramps and abdominal pain, diarrhoea or weight loss (signs of bowel problems).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help to 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 on the packaging after
“Expiry/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 the original packaging to protect the medicine from light.
Bimzelx can be kept outside the refrigerator for a maximum of 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 packaging to write the date on which it was
removed from the refrigerator.
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 Bimzelx contains

• The active substance is bimekizumab. Each pre-filled syringe contains 160 mg of bimekizumab in 1 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 from clear to slightly opalescent. Its colour may range from colourless to
pale straw-yellow-light brown. It is presented in a single-use pre-filled syringe with
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 packs consisting of 3 boxes, each containing
1 pre-filled syringe, or in multiple packs 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, 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

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

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

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

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

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

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

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

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

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

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

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

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

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

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

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

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

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

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

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

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

Ísland
Vistor hf.
Sími: + 354 535 7000

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

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

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

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

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

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

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

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 syringe.
Description of Bimzelx 160 mg in pre-filled syringe ( see Figure A):

A

Syringe

Plunger

body
rod
Needle Head of the

Grip

plunger

Important information

• Your healthcare professional must show you how to prepare and inject Bimzelx using the 160 mg pre-filled syringe. Do notinject yourself or another person 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 have any questions about how to inject Bimzelx correctly.
• Depending on the prescribed dose, you will need to use 1 or 2 pre-filled syringes of Bimzelx160 mg.1 pre-filled syringe is needed for a 160 mg dose and 2 pre-filled syringes (one after the other) are needed for a 320 mg dose.
• Each pre-filled syringe is for single use only.
• The 160 mg pre-filled syringe has a needle safety feature that will automatically cover the needle once the injection is complete. The needle safety feature will help prevent the needle from injuring anyone handling the pre-filled syringe after the injection.

Do not use this medicinal product and return it to the pharmacy if:

• the expiry date (Scad./EXP) has passed;
• the seal on the pack 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 160 mg pre-filled syringe/syringes from the
refrigerator and let it/them stand on a flat surface at room temperature for 30-45 minutesbefore
injecting.

• Do not heat the syringe/syringes in any other way, such as in a microwave oven 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 the injection/injections
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 syringes of Bimzelx 160 mg

You will also need (not included in the pack):

• 1 or 2 alcohol wipes
• 1 or 2 clean cotton balls
• 1 sharps disposal container. See “Dispose 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 the injection are:
• stomach (abdomen) or thigh ( see Figure B);
• the back of the arm ( see Figure C). Bimzelx can only be injected into the back of the arm by a healthcare professional or another person.

B C

abdomen or

back of

thigh
arm

• Do not inject into areas where the skin is sensitive, bruised, red, scaly, hard or in areas with scars or stretch marks.
• Do not inject less than 5 cm from the navel.
• If a second injection is needed 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 wipe
2c: Prepare the skin

• Disinfect the injection site with an alcohol wipe. Allow the area to dry completely. Do not touch the disinfected area again before the injection.

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

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

D

Expiry date

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

• Hold one hand on the syringe flange. With the other hand, remove the needle cap from the pre-filled syringe ( see Figure E). You may see a drop of liquid on the tip of the needle; this is normal.
• Do nottouch the needle and do not let the needle touch any surface.
• Do nothold the plunger while removing the cap. If you accidentally remove the plunger rod, discard the pre-filled syringe in a sharps disposal container and take a new one.
• Do notput the needle cap back on. If you do, you may damage the needle or prick yourself. E

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

• Push the needle all the way 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 has 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 retract
automatically and remain locked in place

I

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

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

If you need to give a second injection 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.

Bimzelx 160 mg injectable solution in a pre-filled pen

bimekizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 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 Bimzelx is and what it is used for
• 2. What you need to know before you use 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 for the treatment of 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 the symptoms, including pain, itching and scaling of the skin.
Psoriatic arthritis
Bimzelx is used for the treatment of adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflammation of the joints, often accompanied by plaque psoriasis. In the case of active psoriatic arthritis, other medications may be given first. If these medications are not effective enough, or in case of intolerance, you will be given Bimzelx as monotherapy or in combination with another medication, known as methotrexate.
Bimzelx reduces inflammation and may therefore help to reduce pain, stiffness, swelling inside and around the joints, psoriatic skin rash, nail damage due to psoriasis and slow down damage to the cartilage and bones of the joints involved in the disease.
These effects can help to control the signs and symptoms of the disease, to facilitate normal daily activities, to reduce fatigue and to improve quality of life.
Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)
Bimzelx is used for the treatment of 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 have visible radiographic signs, it is referred to as “ankylosing spondylitis” or “radiographic axial spondyloarthritis”.
If you suffer from axial spondyloarthritis, you will initially be given other medications. If you do not respond adequately to these medications, you will receive Bimzelx in order to reduce the signs and symptoms of the disease, alleviate inflammation and improve physical function. Bimzelx may help to reduce back pain, stiffness and fatigue, which may help you to 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 painful nodules, abscesses (pus-filled sacs) and lesions from which pus may leak. It most commonly affects specific areas of the skin such as the area under the breast, the armpits, the inner thighs, the groin and the buttocks. Scars may also form in the affected areas. You will first be given other medications. If you do not respond sufficiently well to these medications, you will be given Bimzelx.
Bimzelx reduces inflammatory nodules, abscesses (pus-filled sacs) and lesions from which pus may leak, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active substance of Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimzelx 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, higher levels of these proteins are present.

2. What you need to know before using Bimzelx

Do not use Bimzelx

• if you are allergic to bimekizumab or 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 an infection that keeps coming back;
• you have recently received a vaccination or are planning to receive one. You should not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had an 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 may be signs of
a new inflammatory bowel disease or a worsening of an inflammatory bowel
disease (Crohn's disease or ulcerative colitis).

Pay attention to any infections and allergic reactions
Bimzelx can rarely cause serious infections. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any sign indicating a
serious infection. These signs are listed in section 4 “Serious side effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any sign indicating a serious
allergic reaction. These signs may include:

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

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because 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, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of
Bimzelx during pregnancy. 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 contraception during the use of this medicine
and for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or plan to do so, ask your doctor for advice before using this medicine.
You and your doctor should decide together whether you can breastfeed or take Bimzelx.

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

Bimzelx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium
free”.

3. How to use Bimzelx

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

How much Bimzelx is administered and for how long
Plaque psoriasis
The recommended dose, administered by injections under the skin (‘subcutaneous injections’) is the
following:

• 320 mg (administered with twopre-filled pens containing 160 mg each) at weeks 0, 4, 8, 12, 16;
• from week 16, you will use 320 mg (twopre-filled pens 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 by subcutaneous injection (‘subcutaneous injection’) is the
following:

• 160 mg (administered with onepre-filled pen containing 160 mg) every 4 weeks.
• In case of psoriatic arthritis with coexisting moderate to severe plaque psoriasis, the recommended dosage 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 your joint symptoms.

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

• 160 mg (administered with onepre-filled pen containing 160 mg) every 4 weeks.

Hidradenitis suppurativa
The recommended dose, administered by subcutaneous injections (‘subcutaneous injections’), is the
following:

• 320 mg (administered with twopre-filled pens, containing 160 mg each) every 2 weeks up to week 16.
• From week 16, you will use 320 mg (twopre-filled pens, containing 160 mg each) every 4 weeks.

You and your doctor or nurse will decide whether you will be able to self-administer this medicine. Do not
inject this medicine unless you have been instructed by a healthcare professional. Anyone
caring for you can also perform the injection to administer the medicine to you, after being
trained.
Before injecting Bimzelx 160 mg injectable solution in a pre-filled pen, read carefully the

If you use more Bimzelx than you should
Tell your doctor if you have received more Bimzelx than you should or the dose was administered before
it was due.

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

If you stop using Bimzelx
Talk to your doctor before stopping treatment with Bimzelx. If you stop treatment, the
symptoms may reappear.
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
See a doctor or seek immediatemedical attention if you experience any of the following
side effects:

• 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 assess whether you can continue to use Bimzelx.

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 airway infections with symptoms such as sore throat and stuffy nose

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• low levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including esophageal candidiasis)
• eye discharge with itching, redness and swelling (conjunctivitis)
• blood in stools, cramps and abdominal pain, diarrhea or weight loss (signs of bowel problems.

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 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 packaging 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 the original packaging to protect the medicine from light.
Bimzelx can be kept outside the refrigerator for a maximum of 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 packaging to write the date on which it was
removed from the refrigerator.
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 Bimzelx contains

• The active substance is bimekizumab. Each pre-filled pen contains 160 mg of bimekizumab in 1 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 from clear to slightly opalescent. Its colour may range from colourless to
pale straw-yellow-light brown. It is presented in a single, single-use pre-filled pen.
Bimzelx 160 mg solution for injection in a pre-filled pen is available in packs
containing 1 or 2 pre-filled pens and in multiple packs consisting of 3 cartons, each containing
1 pre-filled pen, or in multiple packs consisting of 2 cartons, 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 on this medicinal product, 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

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

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

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

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

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

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

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

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

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

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

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

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

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

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

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

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

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

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

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

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

Ísland
Vistor hf.
Sími: + 354 535 7000

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

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

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

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

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

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

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

Altre fonti d’informazioni
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 the instructions carefully before using Bimzelx 160 mg solution for injection in
pre-filled pen.
Description of Bimzelx 160 mg in a pre-filled pen ( see Figure A):
A

Observation

window

Cap

Grip

Needle cover

Important information

• A healthcare professional must show you how to prepare and inject Bimzelx using the 160 mg pre-filled pen. Do notinject yourself or another person 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 have any questions about how to inject Bimzelx correctly.
• Depending on the prescribed dose, you will need to use 1 or 2 pre-filled Bimzelx160 mg pens.1 pre-filled pen is required for a 160 mg dose and 2 pre-filled pens (one after the other) are required for a 320 mg dose.
• Each pre-filled pen is for single use only.

Do not use this medicinal product and return it to the pharmacy if:

• the expiry date (Scad./EXP) has passed;
• the seal on the carton 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 160 mg pre-filled pen/pens from the
refrigerator and allow it/them to stand on a flat surface at room temperature for 30-45 minutesbefore
injection.

• Do not heat the pre-filled pen/pens in any other way, for example in a microwave or in hot water.
• Do not shake the pre-filled pen/pens.
• Do not remove the pen cap until you are ready to inject.

Follow these instructions every time you use Bimzelx.
Step 1: prepare for the 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 Bimzelx 160 mg pens

You will also need (not included in the pack):

• 1 or 2 alcohol wipes
• 1 or 2 clean cotton balls
• 1 sharps disposal container. See “Dispose of used Bimzelx pre-filled pen” 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 arm ( see Figure C). Bimzelx can only be injected into the back of the arm by a healthcare professional or another person.

B C

abdomen or

back of

thigh
arm

• Do not inject into areas where the skin is sore, bruised, red, scaly, hard or has scars or stretch marks.
• Do not inject less than 5 cm from the navel.
• If you need to administer a second injection according to 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

• Disinfect the injection site with an alcohol wipe. Allow the area to dry completely. Do not touch the disinfected area again before the injection.

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

• Make sure that the name Bimzelx and the expiry date are legible on the label.
• Check the medicine through the observation window. The medicine should be from clear to slightly opalescent and free of particles. Its colour may range from colourless to pale straw-yellow-light 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

Observation

window

Expiry

date

Step 3: inject Bimzelx
3a: Remove the pen cap

• Hold the pre-filled pen firmly on 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 cover and do not put the cap back on. Otherwise, you may activate the pre-filled pen and 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: Fully attach the pre-filled pen to 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: Continue to hold 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 colour indicator fill the viewing window ( see Figure H).

H

15s

Click

3e: Remove the pre-filled pen by gently lifting it from the skin. The
needle cover 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 a little bleeding or a drop of liquid: this is normal. You can cover the injection site with a small plaster if necessary.

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

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

Bimzelx 320 mg injectable solution in pre-filled syringe

bimekizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 Bimzelx is and what it is used for
• 2. What you need to know before you use 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 ingredient bimekizumab.

What is Bimzelx used for
Bimzelx is used for the treatment of 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 the symptoms, including pain, itching and scaling of the skin.
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. In cases of active psoriatic arthritis, other medications may be given first. If these medications are not effective enough, or in case of intolerance, you will be given Bimzelx as monotherapy or in combination with another medication, known as methotrexate.
Bimzelx reduces inflammation and can therefore help to reduce pain, stiffness, swelling inside and around the joints, psoriatic skin rash, nail damage due to psoriasis and slow down damage to the cartilage and bones of the joints involved in the disease.
These effects can help control the signs and symptoms of the disease, make normal daily 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 for the treatment of 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 have visible radiographic signs, it is referred to as “ankylosing spondylitis” or “radiographic axial spondyloarthritis”.
If you suffer from axial spondyloarthritis, you will initially be given other medications. If you do not respond adequately to these medications, you will receive Bimzelx in order to reduce the signs and symptoms of the disease, reduce inflammation and improve physical function. Bimzelx can help reduce back pain, stiffness and fatigue, which may help you with your 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 (pus-filled sacs), and lesions from which pus may leak. It most commonly affects specific areas of the skin such as the area under the breast, armpits, inner thighs, groin and buttocks. Scars can also form in the affected areas. You will first be given other medications. If you do not respond well enough to these medications, you will be given Bimzelx.
Bimzelx reduces inflammatory nodules, abscesses (pus-filled sacs), and lesions from which pus may leak, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active ingredient contained in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimzelx 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, higher levels of these proteins are present.

2. What you need to know before using Bimzelx

Do not use Bimzelx

• if you are allergic to bimekizumab or 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 an infection that keeps coming back;
• you have recently received a vaccination or are planning to receive one. You should not receive certain types of vaccines (live vaccines) while using Bimzelx;
• you have had tuberculosis (TB);
• you have had an 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 may be signs of
a new inflammatory bowel disease or a worsening of an inflammatory bowel
disease (Crohn’s disease or ulcerative colitis).

Pay attention to any infections and allergic reactions
Bimzelx can rarely cause serious infections. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any signs indicating a
serious infection. These signs are listed in section 4 “Serious side effects”.
Bimzelx can potentially cause serious allergic reactions. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any signs indicating a
serious allergic reaction. These signs may include:

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

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because 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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine. It is preferable to avoid the use of
Bimzelx during pregnancy. 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 contraception during the use of 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 should decide together whether you can breastfeed or take Bimzelx.

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

Bimzelx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium-free”.

3. How to use Bimzelx

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

How much Bimzelx is administered and for how long
Plaque psoriasis
The recommended dose, administered by subcutaneous injection (‘subcutaneous injection’), is the
following:

• 320 mg (administered with onepre-filled syringe containing 320 mg) at weeks 0, 4, 8, 12, 16;
• from week 16, you will use 320 mg (onepre-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 the
following:

• 160 mg every 4 weeks.
• In case of psoriatic arthritis with coexisting moderate to severe plaque psoriasis, the recommended dosage 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 administering 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 the
following:

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

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

• 320 mg (administered with onepre-filled syringe, containing 320 mg) every 2 weeks up to week 16.
• From week 16, you will use 320 mg (onepre-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
inject this medicine unless you have been instructed by a healthcare professional. Anyone
caring for you can also perform the injection to administer the medicine to you, after being
trained.
Before self-injecting Bimzelx 320 mg injectable solution in a pre-filled syringe, read

If you use more Bimzelx than you should
Tell your doctor if you have received more Bimzelx than you should or the dose was administered before
when it was due.

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, the
symptoms may reappear.
If you have any questions about using 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
Seek medical attention immediatelyor go to the nearest emergency room if you experience any of the
following side effects.
Possible serious infections, symptoms may include:

• 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 a painful rash with blisters.

Your doctor will assess whether you can continue to use 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 airway infections with symptoms such as sore throat and stuffy nose

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• low levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including esophageal candidiasis)
• eye discharge with itching, redness and swelling (conjunctivitis)
• blood in stools, cramps and abdominal pain, diarrhea or weight loss (signs of bowel problems).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
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 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 packaging 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 the original packaging to protect the medicine from light.
Bimzelx can be kept outside the refrigerator for a maximum of 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 space on the packaging to write the date on which it was
removed from the refrigerator.
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 Bimzelx contains

• The active substance is bimekizumab. Each pre-filled syringe 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 from clear to slightly opalescent. Its colour may range from colourless to
pale straw-yellow-light brown. It is presented in a single-use pre-filled syringe with
needle cap.
Bimzelx 320 mg solution for injection in a pre-filled syringe is available in packs
containing 1 pre-filled syringe and in multiple packs consisting of 3 cartons, 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 on this medicinal product, 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

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

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

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

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

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

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

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

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

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

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

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

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

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

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

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

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

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

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

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

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

Ísland
Vistor hf.
Sími: + 354 535 7000

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

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

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

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

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

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

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

Altre fonti d’informazioni
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 the instructions carefully before using Bimzelx 320 mg solution for injection in
a pre-filled syringe.
Description of Bimzelx 320 mg in a pre-filled syringe ( see Figure A):

Figure A

Important information

• The healthcare professional must show you how to prepare and inject Bimzelx using the 320 mg pre-filled syringe. Do notinject yourself or another person 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 have any questions about how to inject Bimzelx correctly.
• Each pre-filled syringe is for single use only.
• The 320 mg pre-filled syringe is equipped with a needle safety device that will automatically cover the needle once the injection is complete. The needle safety device will help prevent the needle from injuring anyone handling the pre-filled syringe after the injection.

Do not use this medicinal product and return it to the pharmacy if:

• the expiry date (Scad./EXP) has passed;
• the seal on the carton 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 pre-filled syringe of Bimzelx from the
refrigerator and leave it in its original carton on a flat surface at room temperature for
30-45 minutesbefore injecting.

• Do not heat the syringe(s) in any other way, such as in a microwave oven 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 inject.

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

• 1 Bimzelx 320 mg pre-filled syringe

You will also need (not included in the box):

• 1 alcohol-soaked wipe
• 1 clean cotton ball
• 1 sharps disposal container. See “Dispose of the 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 arm ( see Figure C). Bimzelx can only be injected into the back of the arm by a healthcare professional or another person.

Figure BFigure C

• Do not inject into areas where the skin is sensitive, bruised, red, scaly, hard or areas with scars or stretch marks.
• Do not inject less than 5 cm from 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 wipe
2c: Prepare the skin

• Disinfect the injection site with an alcohol-soaked wipe. Allow the area to dry completely. Do not touch the disinfected area again before the injection.

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

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

Figure D

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

• Hold one hand on the flange of the pre-filled syringe. With the other hand, remove the needle cap from the pre-filled syringe ( see Figure E). You may see a drop of liquid on the tip of the needle; this is normal.
• Do nottouch the needle and do not let the needle touch any surface.
• Do nothold down the plunger when removing the cap. If you accidentally remove the plunger rod, discard the pre-filled syringe in a sharps disposal container and take a new one.
• Do notput the needle cap back on. Otherwise, you may damage the needle or prick yourself.

Figure E

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

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

Figure F

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

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

Figure H

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

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

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

Figure J

Bimzelx 320 mg injectable solution in a pre-filled pen

bimekizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 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 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 for the treatment of 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 scaling of the skin.
Psoriatic arthritis
Bimzelx is used for the treatment of adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflammation of the joints, often accompanied by plaque psoriasis. In cases of active psoriatic arthritis, other medications may be given first. If these medications are not effective enough, or in case of intolerance, you will be given Bimzelx as monotherapy or in combination with another medication, known as methotrexate.
Bimzelx reduces inflammation and may, therefore, help to reduce pain, stiffness, swelling inside and around the joints, psoriatic skin rash, nail damage due to psoriasis and slow down damage to the cartilage and bones of the joints involved in the disease.
These effects can 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 for the treatment of 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 suffer from axial spondyloarthritis, you will initially be given other medications. If you do not respond adequately to these medications, you will receive Bimzelx in order 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 may help you with your 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 (pus-filled sacs) and lesions from which pus may leak. It most commonly affects specific areas of the skin such as the area under the breast, armpits, inner thighs, groin and buttocks. Scars may also form in the affected areas. You will first be given other medications. If you do not respond well enough to these medications, you will be given Bimzelx.
Bimzelx reduces inflammatory nodules, abscesses (pus-filled sacs) and lesions from which pus may leak, as well as the pain caused by hidradenitis suppurativa.

How Bimzelx works
Bimekizumab, the active substance of Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimzelx 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, higher levels of these proteins are present.

2. What you need to know before using Bimzelx

Do not use Bimzelx

• if you are allergic to bimekizumab or 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 an infection that keeps coming back;
• you have recently had a vaccination or are planning to have one. You should 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 may be signs of
new inflammatory bowel disease or worsening of inflammatory bowel
disease (Crohn’s disease or ulcerative colitis).

Pay attention to any infections and allergic reactions
Bimzelx can rarely cause serious infections. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any sign indicating a
serious infection. These signs are listed in section 4 “Serious side effects”.
Bimzelx may potentially cause serious allergic reactions. Contact your doctor or seek

immediatelymedical attention if you notice the appearance of any sign indicating a serious
allergic reaction. These signs may include:

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

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because 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, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of
Bimzelx during pregnancy. 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 contraception during use of this medicine and
for at least 17 weeks after the last dose of Bimzelx.
If you are breastfeeding or plan to breastfeed, ask your doctor for advice before using this medicine.
You and your doctor should decide together 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 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 following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist.

How much Bimzelx is administered and for how long
Plaque psoriasis
The recommended dose, administered by injection under the skin (‘subcutaneous injection’) is the
following:

• 320 mg (administered with onepre-filled pen containing 320 mg) at weeks 0, 4, 8, 12, 16;
• from week 16, you will use 320 mg (onepre-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 injection under the skin (‘subcutaneous injection’) is the
following:

• 160 mg every 4 weeks.
• In case of psoriatic arthritis with coexisting moderate to severe plaque psoriasis, the recommended dosage 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 your joint symptoms. Other pharmaceutical forms/concentrations are available for administering the 160 mg dose.

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

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

Hidradenitis suppurativa
The recommended dose, administered by injection under the skin (‘subcutaneous injection’), is the
following:

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

You and your doctor or nurse will decide whether you will be able to self-administer this medicine. Do not
inject this medicine unless you have been instructed by a healthcare professional. Anyone
caring for you can also administer the injection to you after being
trained.
Before injecting Bimzelx 320 mg injectable solution in a pre-filled pen, read carefully the

If you use more Bimzelx than you should
Tell your doctor if you have received more Bimzelx than you should or the dose was administered before
when it was due.

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, the
symptoms may return.
If you have any questions about using 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
See a doctor or get immediatemedical help if you get any of the following side effects:

• fever, flu-like symptoms, night sweats
• fatigue or shortness of breath, cough that doesn't go away
• warm, red, and painful skin, or a painful rash with blisters.

The doctor will assess whether you can continue to use Bimzelx.

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 airway infections with symptoms such as sore throat and stuffy nose

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• low levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• blood in your stools, cramps and abdominal pain, diarrhoea or weight loss (signs of bowel problems.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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 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 packaging after
“Expiry/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 the original packaging to protect the medicine from light.
Bimzelx can be kept outside the refrigerator for a maximum of 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 space on the packaging to write the date on which it was
removed from the refrigerator.
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. Content of the pack 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 components are glycine, sodium acetate trihydrate, glacial acetic acid, polysorbate 80 and water for injections.

Description of the appearance of Bimzelx and content of the pack
Bimzelx is a liquid from clear to slightly opalescent. Its colour may range from colourless to
pale straw-yellow-light brown. It is presented in a single, disposable pre-filled pen.
Bimzelx 320 mg solution for injection in a 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, 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

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

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

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

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

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

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

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

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

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

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

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

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

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

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

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

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

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

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

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

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

Ísland
Vistor hf.
Sími: + 354 535 7000

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

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

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

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

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

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

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

Altre fonti d’informazioni
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 the instructions carefully before using Bimzelx 320 mg solution for injection in
a pre-filled pen.
Description of Bimzelx 320 mg in a pre-filled pen ( see Figure A):

Figure A

Important information

• The healthcare professional must show you how to prepare and inject Bimzelx using the 320 mg pre-filled pen. Donot inject yourself or another person 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 have any questions about how to inject Bimzelx correctly.
• Each pre-filled pen is for single use only (single-patient use).

Do not use this medicinal product and return it to the pharmacy if:

• the expiry date (Scad./EXP) has passed;
• the seal on the carton 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 allow it to
stand in its original carton on a flat surface at room temperature for 30-45 minutes
before injection.

• Do not heat the pre-filled pen/pre-filled pens in any other way, for example in a microwave oven or in hot water.
• Do not shake the pre-filled pen.
• Do not remove the pen cap until you are ready to administer the injection.

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

• 1 Bimzelx 320 mg pre-filled pen

You will also need (not included in the carton):

• 1 alcohol wipe
• 1 clean cotton ball
• 1 sharps disposal container. See “Dispose of the used Bimzelx pre-filled pen” 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 the injection are:
• stomach (abdomen) or thigh ( see Figure B);
• the back of the arm ( see Figure C). Bimzelx can only be injected into the back of the arm by a healthcare professional or another person.

Figure BFigure C

• Do not inject into areas where the skin is sensitive, bruised, red, scaly, hardened or areas with scars or stretch marks.
• Do not inject less than 5 cm from 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 wipe
2c: Prepare the skin

• Disinfect the injection site with an alcohol wipe. Allow the area to dry completely. Do not touch the disinfected area again before the injection.

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

• Make sure the name Bimzelx and the expiry date are legible on the label.
• Check the medicine through the viewing window. The medicine should be from clear to slightly opalescent and free of particles. Its colour may range from colourless to pale straw-yellow-light 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.

Figure D

Step 3: Inject Bimzelx
3a: Remove the pen cap

• Hold the pre-filled pen firmly on 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 cover and do not put the cap back on. Otherwise, you may activate the pre-filled pen and injure yourself.

Figure E

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

3c: Fully attach the pre-filled pen to 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.
Figure G

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

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

Figure H

• After the second click, continue to hold the pen pressed for another 5 seconds(counting slowly to 5). This ensures delivery of theentire dose(see Figure I).

Figure I

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

• Press a clean 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 can cover the injection site with a small plaster, if needed.

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

Figure J