Bimzelx 320 mg solucion inyectable en pluma precargada

Prospect: information for the user

Bimzelx320mg solution for injection in a 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 section4includes 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 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 do not appear in this prospect. See section4.

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.

Psoriatic arthritis

Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflammation of the joints, often accompanied by plaque psoriasis. If 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 cartilage and bone damage in the affected joints. 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 section6).
• 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 section4.

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 include:

• 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 under18years 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 should use contraception while using this medication and for at least17weeks 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 should 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 per ml of solution. Polisorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Bimzelx contains sodium

This medication contains less than1mmol (23mg) of sodium per dose; this is, essentially “sodium-free”.

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.

How much Bimzelx is administered and for how long

Plaque psoriasis

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

• 320 mg (administered in one pre-filled syringe with 320 mg) at weeks 0, 4, 8, 12, and 16.
• From week 16, you will use 320 mg (one pre-filled syringe with 320 mg) 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 a subcutaneous injection, is as follows:

• 160 mg every 4 weeks.
• If you have coexisting moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust the injections to 160 mg every 4 weeks, based on your joint symptoms. There are other pharmaceutical forms/concentrations available for the administration of 160 mg.

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

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

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

Hidradenitis supurativa

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

• 320 mg (administered in one pre-filled syringe with 320 mg) every 2 weeks until week 16.
• From week 16, you will receive 320 mg (one pre-filled syringe with 320 mg each) every 4 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 pre-filled syringe of Bimzelx 320 mg injectable 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 assistanceimmediatelyif 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 than1person in every10)

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

Common(may affect up to1person in every10people)

• oral or throat candidiasis with symptoms such as white or yellow patches; redness or sores in the mouth and difficulty 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)

Rare(may affect up to1person in every100people)

• 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, 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 not listed in this leaflet. You can also report them directly through thenationalreporting 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/CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator between2°C and8°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 of25days. It must be stored in the outer packaging, at no more than25°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 the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Bimzelx

• The active ingredient is bimekizumab. Each pre-filled pen contains320mg of bimekizumab in2ml of solution.
• The other components are glycine, sodium acetate trihydrate, glacial acetic acid, polisorbate80and 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 single-use disposable pre-filled pen.

Bimzelx 320mg injectable solution in pre-filled pen is available in packs containing1pre-filled pen and in multiple packs of3boxes, each containing1pre-filled pen

Only some pack sizes may be marketed.

Marketing Authorization Holder

UCB Pharma S.A.

Allée de la Recherche60

B-1070Brussels, Belgium

Responsible for manufacturing

UCB Pharma S.A.

Chemin du Foriest

B-1420Braine-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

The detailed 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 320mg pre-filled pen.

Bimzelx 320mg pre-filled pen at a glance (see figureA):

Important information:

• Your healthcare professional should teach you how to prepare and inject Bimzelx using the 320 mg pre-filled pen.Do notinject yourself or someone else 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.
• 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/CAD) has passed.
• The packaging is damaged.
• 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 320mg pre-filled pen out of the refrigerator and leave it on a flat surface at room temperature in its original packaging for30-45minutesbefore injection.

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

Follow the steps below each time you use Bimzelx.

Step1: Preparation of the injection

Place the following items on a clean, flat, and well-lit work surface, such as a table:

• 1 Bimzelx 320mg pre-filled pen

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

• 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.

Step2: Choose the injection site and prepare the injection

2a: Choose the injection site

• The sites you can choose for the injection are:
• • The abdomen (tummy) or thigh (see figureB);
  • You can also use the back of the arm, if a caregiver is administering the injection (see figureC).

• Do not inject in areas where the skin is sensitive, discolored, red, scaly, or hard, or in areas with scars or stretch marks.
• Do not inject within5cm of the navel.
• You should 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, 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 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 from the pre-filled pen

• Hold the pre-filled pen firmly with one hand by the barrel. Pull the cap straight off with the other hand (see figureE). Although you cannot see the needle tip, 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 you to prick yourself.

3b: Hold the pre-filled pen at a90degree angle to the cleaned skin 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).

3d: Hold the pre-filled pen in place and press it firmly against the skin. It will take approximately20seconds to receive the full dose.

• You will hear a second “click” that indicates the injection is almost complete.
• You will see the yellow indicator filling the viewing window (see figureH).

• After the second click, continue to press the pre-filled pen for another5seconds (count slowly to5). This will ensure you receive the full dose (see Figure I).

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 small amount of 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 disposal container immediately after use (see figureJ).