BIMZELX 160 mg Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the User

Bimzelx 160 mg solution for injection in pre-filled pen

bimekizumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Bimzelx and what is it used for
2. What you need to know before you use Bimzelx
3. How to use Bimzelx
4. Possible side effects
5. Storage of Bimzelx
6. Package contents and further information Instructions for use

1. What is Bimzelx and what is it used for

What is Bimzelx

Bimzelx contains the active substance bimekizumab.

What is Bimzelx used for

Bimzelx is used to treat the following inflammatory diseases:

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

Plaque psoriasis

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

Psoriatic arthritis

Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes joint inflammation, often accompanied by plaque psoriasis. If you have active psoriatic arthritis, you may have been given other medicines before. If these medicines do not work well enough or if you cannot tolerate them, you will receive Bimzelx alone or in combination with another medicine called methotrexate.

Bimzelx reduces inflammation and can help reduce pain, stiffness, swelling in the joints and around them, psoriatic skin rash, and 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 daily activities, reduce fatigue, and improve quality of life.

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

Bimzelx is used to treat adults with a disease that mainly affects the spine and causes inflammation of the joints in the spine, 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 medicines. If you do not respond well enough to these medicines, you will be given Bimzelx to reduce the signs and symptoms of the disease, decrease inflammation, and improve your physical functional ability. Bimzelx can help reduce back pain, stiffness, and fatigue, making it easier to perform daily activities and improve quality of life.

Hidradenitis suppurativa

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

Bimzelx reduces inflammatory nodules (lumps), abscesses (boils), and lesions that can ooze pus, as well as pain caused by hidradenitis suppurativa.

How Bimzelx works

Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin inhibitors (IL). Bimekizumab works 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 suppurativa.

2. What you need to know before you use 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 that your doctor thinks is important, such as tuberculosis (TB).

• If you have an infection or an infection that keeps coming back.
• If you have been vaccinated recently or are planning to be vaccinated. During treatment with Bimzelx, some vaccines (those made with live microbes) should not be given.
• If you have ever had tuberculosis (TB).
• If you have ever had inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before starting treatment with Bimzelx if:

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

Stop using Bimzelx and tell your doctor or seek medical attention immediately if you notice blood in your stool, 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 risk of infections and allergic reactions

Rarely, Bimzelx can cause serious infections. Talk to your doctor or seek medical attention immediately if you notice any signs of serious infection. These signs are listed in "Serious side effects" in section 4.

Bimzelx can cause serious allergic reactions. Talk to your doctor or seek medical attention immediately if you notice any signs of a serious allergic reaction. These signs may include:

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

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and Bimzelx

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 recommended to avoid using Bimzelx during pregnancy, as it is not known how this medicine will affect the baby.

If you are a woman who can 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 will decide whether you can breastfeed or use Bimzelx.

Driving and using machines

Bimzelx is unlikely to affect your ability to drive or use machines.

Bimzelx contains polysorbate 80

This medicine contains 0.4 mg of polysorbate 80 per ml of solution. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergies.

Bimzelx contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to use Bimzelx

Plaque psoriasis

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much Bimzelx to use and for how long

• The recommended dose, given as injections under the skin ("subcutaneous injections"), is as follows:
• 320 mg (given in two pre-filled pens with 160 mg each) at weeks 0, 4, 8, 12, and 16.
• From week 16 onwards, 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, given as an injection under the skin ("subcutaneous injection"), is as follows:

• 160 mg (given in one pre-filled pen containing 160 mg) every 4 weeks.
• If you have co-existing psoriatic arthritis with moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust the injections to 160 mg every 4 weeks, depending on your joint symptoms.

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

The recommended dose, given as an injection under the skin ("subcutaneous injection"), is 160 mg (in one pre-filled pen containing 160 mg) every 4 weeks.

Hidradenitis suppurativa

The recommended dose, given as injections under the skin ("subcutaneous injections"), is as follows:

• 320 mg (given in two pre-filled pens with 160 mg each) every 2 weeks until week 16.
• From week 16 onwards, you will receive 320 mg (two pre-filled pens with 160 mg each) every 4 weeks.

You and your doctor or nurse will decide if you should inject this medicine yourself. Do not inject this medicine unless a healthcare professional has taught you how to do it. A caregiver can also give you 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 pen of Bimzelx 160 mg solution for injection yourself.

If you use more Bimzelx than you should

Tell your doctor if you have used more Bimzelx than you should or if you have injected a 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 stop using Bimzelx

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

If you have any other 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

Tell your doctor or seek medical attention immediately if you experience any of the following side effects:

Possible serious infection - the signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or having trouble 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

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

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

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

Common (may affect up to 1 in 10 people)

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

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

Uncommon (may affect up to 1 in 100 people)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton after EXP. The expiry date refers to the last day of the month shown.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled pens in the original carton to protect them from light.

Bimzelx can be stored at room temperature (up to 25°C) for a maximum of 25 days. It must be kept in the outer packaging and away from direct light. Do not use the pre-filled pens after this time. There is a space on the carton for you to write the date you removed it from the refrigerator.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Bimzelx Composition

• 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, polysorbate 80, and water for injectable preparations.

Appearance of Bimzelx and Container Contents

Bimzelx is a clear to slightly opalescent liquid. The color may vary from colorless to light brownish yellow. It comes in a single-use, disposable 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 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

Manufacturer

UCB Pharma S.A.

Chemin du Foriest

B-1420 Braine-l’Alleud, Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu

Instructions for Use

Read the following instructions in their entirety before using the Bimzelx 160 mg pre-filled pen.

Bimzelx 160 mg Pre-filled Pen 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 pen. Do notinject yourself or another person until you have been taught 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 questions about how to inject Bimzelx correctly.
• Depending on the prescribed dose, you must use 1 or 2 Bimzelx 160 mg pre-filled pens.For a 160 mg dose, one pre-filled pen is needed, and for a 320 mg dose, two pre-filled pens are needed (consecutively).
• Each pre-filled pen is for single use only.

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

• The expiration date (EXP) has passed.
• The pack is damaged.
• The pre-filled pen has been dropped or appears to be damaged.
• The liquid has been frozen at any time (even if it has been thawed).

For a more comfortable injection:Remove the 160 mg pre-filled pen(s) from the refrigerator and let it/them sit on a flat surface at room temperature for 30-45 minutesbefore 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(s).
• Do not remove the cap from the pre-filled pen(s) until you are ready to inject.

Follow the steps below each time you use Bimzelx.

Step 1: Prepare the Injection(s)

Depending on the prescribed dose, place the following items on a clean, flat, and well-lit work surface, such as a table:

• 1 or 2 Bimzelx 160 mg pre-filled pens

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

• 1 or 2 alcohol swabs
• 1 or 2 clean cotton balls
• 1 container for disposing of sharp objects. 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 injection sites you can choose from are:
• • The 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 caregiver.

• Do not inject into areas where the skin is sensitive, bruised, 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 needed for the prescribed dose (320 mg), 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 well with soap and water and dry them with a dry, clean towel

2c: Prepare the skin

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

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

• Make sure the name Bimzelx and the expiration date appear on the label.
• Check the medicine through the viewing window. The medicine should be clear to slightly opalescent and free of particles. The color may vary from colorless to light brownish yellow. 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.

Step 3: Inject Bimzelx

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

• Hold the pre-filled pen firmly with one hand by the handle. Pull the cap straight off the pre-filled pen with the other hand (see Figure E). Although you cannot see the needle tip, it is now exposed.
• Do not touch the needle shield or replace the cap. This is because you could activate the pre-filled pen and stick yourself.

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

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 Figure G).

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" 15 seconds after the first click.
• The second click indicates that all the medicine has been injected and the Bimzelx injection is complete. You should see the yellow indicator filling the viewing window (see Figure H).

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

• Press a dry 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 band-aid if needed.

Step 4: Dispose of the Used Bimzelx Pre-filled Pen

Place the used pre-filled pen in a container for disposing of sharp objects immediately after use (see Figure I).

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

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