Prospect: information for the user

Bimzelx 160 mg pre-filled syringe injectable solution

bimekizumab

This medicine is subject to additional monitoring, which will facilitate 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 doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only to you, and you should 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 do not appear in this prospect. See section 4.

1.What is Bimzelx and what it is 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 psoriasis

Bimzelx is used in adults to treat a skin disorder 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)

Bimzelx is 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 given Bimzelx to reduce the signs and symptoms of the disease, decrease 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 the 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 components of this medication

(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. Speak with 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. Speak with your doctor or seek medical assistance immediatelyif 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 medication should not be administered to children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medications and Bimzelx

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

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

If you are a woman and may become pregnant, you must use contraceptives while using this medication 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 medication. 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 medication 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 medication contains less than 1 mmol (23 mg) of sodium per dose; it is essentially “sodium-free”.

Plaque Psoriasis

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

Chow Bimzelx is administered and for how long

• The recommended dose, administered in the form of subcutaneous injections, is as follows:
• 320 mg (administered in two pre-filled pens with 160 mg each) in weeks 0, 4, 8, 12, and 16.
• From week 16, you will use 320 mg (two pre-filled pens with 160 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:

• 160 mg (administered inonepre-filled pen containing 160 mg) every 4 weeks.
• 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 160 mg every4 weeks, 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 160 mg (inonepre-filled pen containing 160 mg) every 4 weeks.

Hidradenitis Suppurativa

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

• 320 mg (administered intwopre-filled pens with 160 mg each) every 2 weeks until week 16.
• From week16, you will receive 320 mg (twopre-filled pens with 160 mg each) every4 weeks.

You and your doctor or nurse will decide whether to 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 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

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

If you stop using Bimzelx

Speak with 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- 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:

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 infections (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 on 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 CAD. 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 preloaded pens in the original box 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 preloaded pens 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 drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Bimzelx

• The active ingredient is bimekizumab. Each pre-filled pen contains 160 mg of bimekizumab in 1 ml of solution.
• The other components are glycine, sodium acetate trihydrate, glacial acetic acid, 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 pen for single use.

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 of 3 boxes, each containing 1 pre-filled pen, or multiple packs of 2 boxes, each containing 2 pre-filled pens.

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 medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

Further information on this medicine 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 pre-filled pen.

Pre-filled pen of Bimzelx 160 mg at a glance (see figureA):

Important information:

• Your healthcare professional must teach you how to prepare and inject Bimzelx using the 160 mg pre-filled pen.Do not inject yourself or someone else until you have been taught how to inject Bimzelx correctly.
• You and/or your caregiver must 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.
• Depending on the prescribed dose, you must use1 or 2pre-filled pens of Bimzelx 160 mg.For a dose of 160mg, one pre-filled pen is needed, and for a dose of 320mg, two consecutive pre-filled pens are needed.
• Each pre-filled pen is for single use only.

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

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

For a more comfortable injection:Take the pre-filled pen(s) of Bimzelx 160 mg out of the refrigerator and leave it/them on a flat surface at room temperature for30-45minutesbefore injection.

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

Follow the steps below each time you use Bimzelx.

Step1: 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 2pre-filled pens of Bimzelx 160 mg

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

• 1 or 2alcohol wipes
• 1 or 2clean cotton balls
• 1sharps container. See “Dispose of the used Bimzelx pre-filled pen” at the end of these instructions for use.

Step2: Choose the injection site and prepare the injection

2a: Choose the injection site

• The injection sites you can choose are:
• • The abdomen (tummy) or thigh (see figureB);
  • 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 within5cm of the navel.
• If a second injection is needed 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 injection.

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

• Make sure the name Bimzelx and the expiry date appear on the label.
• Check the medicine through the viewing window. The medicine 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 pen if the medicine is cloudy, has changed color, or contains particles.

Step3: Inject Bimzelx

3a: Remove the cap of the pre-filled pen

• Hold the pre-filled pen firmly with one hand by the barrel. Pull the cap of the pre-filled pen directly off with the other hand (see figureE). Although you cannot see the tip of the needle, it is now exposed.
• Do not touch the needle guard or put the cap back on. This could activate the pre-filled pen and cause a needlestick injury.

3b: Hold the pre-filled pen at an angle of90degrees to the cleaned injection site (see figureF)

3c: Place the pre-filled pen flat against the skin and, then, press the pre-filled pen firmly against the skin

You will hear a click. The injection starts when you hear the first “click” (see figureG).

Do not lift the pre-filled pen away from the skin.

3d: Hold the pre-filled pen in place and press it firmly against the skin

• You will hear a second “click” 15seconds after the first click.
• The second click indicates that all the medicine has been injected and that the Bimzelx injection has finished. You should see the yellow indicator filling the viewing window (see figureH).

3e: Remove the pre-filled pen by pulling it out carefully. The needle guard will automatically cover the needle

• Press a clean cotton ball against 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 bandage, if needed.

Step4: Dispose of the used Bimzelx pre-filled pen

Place the used pre-filled pen in a sharps container immediately after use (see figureI).

If you need a second injection because your doctor has prescribed it, use a new Bimzelx 160 mg pre-filled pen and repeat steps2-4.

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