Prospect: information for the user

Bimzelx 160 mg injectable solution in pre-filled syringe

bimekizumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Bimzelx and what is it used for

2.What you need to know before starting to use Bimzelx

3.How to use Bimzelx

4.Possible adverse effects

5.Storage of Bimzelx

6.Contents of the package and additional information Instructions for use

What is Bimzelx

Bimzelx contains the active ingredient 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 supurativa

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

Psiatic 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 you have active psoriatic arthritis, you may have been given other medications first. If these medications do not work well enough or if you are intolerant, you will receive Bimzelx alone or in combination with another medication called methotrexate.

Bimzelx reduces inflammation and can help reduce joint pain, stiffness, swelling in the joints and around them, psoriatic skin rash, and psoriatic nail damage, as well as slow down joint cartilage and bone damage. These effects help control the signs and symptoms of the disease, make it easier to perform your daily activities, reduce fatigue, and improve your quality of life.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)

Bimzelxis used to treat adults with an inflammatory disease that mainly affects the spine and causes inflammation of the spine joints, called axial spondyloarthritis. If the condition is not visible on X-rays, it is called “non-radiographic axial spondyloarthritis”; if it occurs in patients with visible signs on X-rays, it is called “ankylosing spondylitis” or “radiographic axial spondyloarthritis”.

If you have axial spondyloarthritis, you will first be given other medications. If you do not respond well enough to these medications, you will be givenBimzelxto reduce the signs and symptoms of the disease, reduce inflammation, and improve your physical functional capacity. Bimzelx can help reduce back pain, stiffness, and fatigue, making it easier to perform your daily activities and improving your quality of life.

Hidradenitis supurativa

Bimzelx is used in adults to treat a disease called hidradenitis supurativa (sometimes called inverse acne or Verneuil's disease). Hidradenitis supurativa is a chronic inflammatory skin disease that causes painful lesions in the form of nodules (bumps) and abscesses (boils), as well as lesions that can suppurate pus. It mainly affects specific areas of the skin, such as under the breasts, armpits, the inner thighs, groin, and buttocks. In affected areas, scars can also form. You will first be given other medications. If your response to these medications is not sufficient, you will be given Bimzelx.

Bimzelx reduces inflammatory nodules (bumps), abscesses (boils), and lesions that can suppurate pus, as well as the pain caused by hidradenitis supurativa.

How Bimzelx works

Bimekizumab, the active ingredient in Bimzelx, belongs to a group of medications called interleukin inhibitors (IL). Bimekizumab acts by reducing the activity of two interleukins called IL-17A and IL-17F, which are involved in the production of inflammation. The levels of these interleukins are elevated in inflammatory diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis supurativa.

Do not use Bimzelx

• if you are allergic to bimekizumab or any of the other ingredients in this medicine

(listed in section 6).

• if you have an infection that your doctor considers important, for example, tuberculosis (TB).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Bimzelx if:

• You have an infection or a recurring infection.
• You have recently been vaccinated or plan to be vaccinated. During treatment with Bimzelx, some vaccines (those made with live microorganisms) should not be administered.
• You have ever had tuberculosis (TB).
• You have ever had inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Stop using Bimzelx and inform your doctor or seek medical assistance immediately if you observe blood in your stools, abdominal cramps, pain, diarrhea or weight loss. These may be signs of the onset or worsening of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Be aware of the appearance of infections and allergic reactions

In rare cases, Bimzelx may cause severe infections. Talk to your doctor or seek medical assistanceimmediatelyif you observe any signs of severe infection. These signs are listed in “Severe adverse reactions” in section 4.

Bimzelx may cause severe allergic reactions. Talk to your doctor or seek medical assistanceimmediatelyif you observe any signs of severe allergic reaction. These signs may be:

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

Children and adolescents

This medicine should not be administered 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 using, have used recently or may need to use any other medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine. It is preferable to avoid using Bimzelx during pregnancy, as it is not known how this medicine may affect the baby.

If you are a woman and may become pregnant, you must use contraceptives while using this medicine and for at least 17 weeks after the last dose of Bimzelx.

If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether you can breastfeed or use Bimzelx.

Driving and operating machinery

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

Bimzelxcontainspolisorbate 80

This medicine contains 0.4mg of polisorbate 80 in each ml of solution. Polisorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Bimzelx contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Bimzelx is administered and for how long

Plaque psoriasis

The recommended dose, administered in the form of subcutaneous injections, is as follows:

• 320 mg (administered intwopre-filled syringes containing160 mg each) in weeks 0, 4, 8, 12, and 16.
• From week 16, you will use 320 mg (twopre-filled syringes containing160 mg each) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue with injections every 4 weeks from week 16.

Psoriatic arthritis

The recommended dose, administered in the form of subcutaneous injection, is as follows:

• 160mg (administered inonepre-filled syringe containing 160mg) every 4weeks.
• If you have coexisting moderate to severe plaque psoriasis and psoriatic arthritis, the recommended dosing regimen is the same as for plaque psoriasis. After week16, your doctor may adjust the injections to 160mg every4weeks, based on your joint symptoms.

Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis)

The recommended dose, administered via a subcutaneous injection, is as follows:

• 160mg (inonepre-filled syringethat contains 160mg) every 4weeks.

Hidradenitis suppurativa

The recommended dose, administered in the form of subcutaneous injections, is as follows:

• 320mg (administered intwopre-filled syringes with 160mg each) every 2weeks until week 16.
• From week16, you will receive 320mg (twopre-filled syringes with 160mg each) every4weeks.

You and your doctor or nurse will decide if you should inject this medication yourself. Do not inject this medication unless a healthcare professional has taught you how to do it. A caregiver can also administer the injections if they have been taught how to do it.

Read the “Instructions for use” at the end of this leaflet before injecting the pre-filled syringe of Bimzelx 160 mg injectable solution yourself.

If you use more Bimzelx than you should

Inform your doctor if you have used more Bimzelx than you should or if you have injected the dose too early.

If you forget to use Bimzelx

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

If you interrupt treatment with Bimzelx

Talk to your doctor before stopping the use of Bimzelx. If you stop treatment, symptoms may reappear.

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

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

Severe side effects

Inform your doctor or seek medical assistance immediately if you experience any of the following severe side effects:

Severe infection- the symptoms may include:

• fever, flu-like symptoms, night sweats
• feeling tired or difficulty breathing, persistent cough
• heat, redness, and pain in the skin or a painful rash with blisters

Your doctor will decide if you can continue using Bimzelx.

Other side effects

Inform your doctor, pharmacist, or nurse if you experience any of the following side effects:

following side effects:

Very common(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

• oral or throat candidiasis with symptoms such as yellow or white patches;

• redness or sores in the mouth and pain when swallowing
• skin fungal infections, such as athlete's foot between the toes
• ear infections
• fevers (herpes simplex infections)
• stomach flu (gastroenteritis)
• inflammation of hair follicles, which may appear as pimples
• headache
• itching, dry skin, or a rash similar to eczema, sometimes with swollen and
• red skin (dermatitis)
• acne
• redness, pain, or swelling and bruising at the injection site
• feeling tired
• vulvovaginal fungal infection (vaginal candidiasis)

Uncommon(may affect up to 1 in 100 people)

• low white blood cell count (neutropenia)
• skin and mucous membrane fungal infections (including esophageal candidiasis)
• eye discharge with itching, redness, and swelling (conjunctivitis)
• blood in the stool, cramps, and abdominal pain, diarrhea, or weight loss (signs of intestinal problems)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging after EXP. The expiration date is the last day of the month indicated.

Store in refrigerator between 2 °C and 8 °C. Do not freeze.

Store the pre-filled syringes in the original packaging to protect them from light.

Bimzelx can be stored outside the refrigerator for a maximum of 25 days. It must be stored in the outer packaging, at no more than 25 °C and away from direct light. Do not use the pre-filled syringes after this period of time. There is a space in the box for you to write the date when you took it out of the refrigerator.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This way, you will help protect the environment.

Composition of Bimzelx

• The active ingredient 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, polisorbate 80, and water for injection.

Appearance of Bimzelx and contents of the pack

Bimzelx is a transparent to slightly opalescent liquid. The color may vary from colorless to light yellowish brown. It comes in a disposable pre-filled syringe with a needle cap.

Bimzelx 160 mg solution for injection in pre-filled syringe is available in single-unit packs containing 1 or 2 pre-filled syringes and in multiple packs with 3 boxes, each containing 1 pre-filled syringe, or in multiple packs with 2 boxes, each containing 2 pre-filled syringes.

Only some pack sizes may be marketed.

Marketing Authorization Holder

UCB Pharma S.A.

Allée de la Recherche 60

B-1070 Brussels, Belgium

Responsible for manufacturing

UCB Pharma S.A.

Chemin du Foriest

B-1420 Braine-l’Alleud, Belgium

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The 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 the following instructions carefully before using the Bimzelx 160 mg solution for injection in a pre-filled syringe.

Pre-filled syringe of Bimzelx 160 mg at a glance (see Figure A):

Important information:

• Your healthcare professional should teach you how to prepare and inject Bimzelx using the 160 mg pre-filled syringe. Do not inject yourself or another person until you have been taught how to inject Bimzelx correctly.
• You and/or your caregiver should read these instructions before each use of Bimzelx.
• Call your healthcare professional if you or your caregiver have any doubts about how to inject Bimzelx correctly.
• Bimzelx 160 mg solution for injection in a pre-filled syringe is available in single-unit packs containing 1 or 2 pre-filled syringes and in multiple packs with 3 boxes, each containing 1 pre-filled syringe, or in multiple packs with 2 boxes, each containing 2 pre-filled syringes.
• Only some pack sizes may be marketed.

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

• The expiry date (EXP) has passed.
• The closure of the pack is broken.
• The pre-filled syringe has fallen or appears damaged.
• The liquid has frozen at any time (although it has been thawed).

For a more comfortable injection:Squeeze the pre-filled syringe of Bimzelx 160 mg out of the refrigerator and leave it on a flat surface at room temperature for 30-45 minutes before injection.

• Do not heat it in any other way, such as in a microwave or with hot water.
• Do not shake the pre-filled syringe.
• Do not remove the needle cap until you are ready to inject.

Follow the steps below each time you use Bimzelx.

Step 1: Preparation of the injection(s)

Depending on the prescribed dose, place the following items on a clean, flat, and 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 wipes
• 1 or 2 clean cotton balls
• 1 sharps 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 sites you can choose for the injection are:

• The stomach (abdomen) or thigh (see Figure B);
• The back of the arm (see FigureC). Bimzelx can only be injected into the back of the arm by a healthcare professional or caregiver.

• Do not inject into areas where the skin is sensitive, discolored, red, scaly, or hard, or into 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 (320mg),you must 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, dry towel

2c: Prepare the skin

• Clean the injection site with an alcohol wipe. Let the area dry completely. Do not touch the cleaned area before the injection.

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

• Make sure the name Bimzelx and the expiry date appear on the label.
• Check the medicinal product through the viewing window. The medicinal product should be transparent to slightly opalescent and free of particles. The color may vary from colorless to light yellowish brown. You may see air bubbles in the liquid. This is normal.
• Do not use the Bimzelx pre-filled syringe if the medicinal product is cloudy, has changed color, or contains particles.

Step 3: Inject Bimzelx

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

• Hold the pre-filled syringe by the hand grip with one hand. Pull the needle cap straight off the pre-filled syringe with the other hand (see Figure E). You may see a drop of liquid at the tip of the needle; this is normal.

• Do not touch the needle or let the needle touch any surface.
• Do not keep the plunger rod pressed when removing the needle cap. If you accidentally extract the plunger rod, throw the pre-filled syringe in the sharps container and use a new one.
• Do not replace the needle cap. If you do, you may damage the needle or prick yourself by accident.

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

• Push the needle in until it is fully inserted. Then, release the skin carefully. Make sure the needle is in place (see Figure F).

3c: Push the plunger rod firmly until all the medicinal product has been injected (see Figure G)

The medicinal product has been injected in its entirety when it is no longer possible to push the plunger rod further (see Figure H).

3d: Separate the finger from the plunger rod (see Figure I).

The needle will automatically retract and remain in place

• Press a clean cotton ball against the injection site for a few seconds. Do not rub the injection site. You may see a slight bleeding or a drop of liquid. This is normal. You can cover the injection site with a bandage, if necessary.

Step 4: Dispose of the used Bimzelx pre-filled syringe

Place the used Bimzelx pre-filled syringe in a sharps container immediately after use (see Figure J).

If you need a second injection because your doctor has prescribed it, use a new Bimzelx 160 mg pre-filled syringe and repeat steps 2-4.

Make sure to select a new injection site for the second injection.