Bimzelx 160 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bimzelx 160 mg solution for injection in pre-filled syringe

bimekizumab

This medicinal product is subject to additional monitoring, which will enable rapid detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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 Bimzelx is and what it is used for

What Bimzelx is

Bimzelx contains the active substance 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 suppurativa

Plaque psoriasis
Bimzelx is used in adults to treat a skin disorder 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 first been given other medicines. If these medicines are not effective enough or if you are intolerant to them, you will be given Bimzelx either alone or in combination with another medicine called methotrexate.

Bimzelx reduces inflammation and therefore may help reduce joint pain, stiffness, swelling in and around the joints, psoriatic skin rash, and psoriatic nail damage, as well as slow down cartilage and bone damage in the joints affected by the disease. These effects help you control the signs and symptoms of the disease, make your daily activities easier, 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 spinal 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 medicines. If you do not respond adequately to these medicines, you will be given Bimzelx to reduce the signs and symptoms of the disease, decrease inflammation, and improve your physical functional capacity. Bimzelx may help reduce back pain, stiffness, and fatigue, which may make your daily activities easier and improve your 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 nodules (lumps) and abscesses (boils), as well as lesions that may discharge pus. It mainly affects specific areas of the skin, such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in the affected areas. You will first be given other medicines. If your response to these medicines is insufficient, you will be given Bimzelx.

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

How Bimzelx works
Bimekizumab, the active substance in Bimzelx, belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab works by reducing the activity of two interleukins called IL-17A and IL-17F, which are involved in causing inflammation. 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 using Bimzelx

Do not use Bimzelx

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

(listed in section 6).

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

Warnings and precautions

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

• You have an infection or an infection that keeps recurring.
• You have recently been vaccinated or are planning to get vaccinated. During treatment with Bimzelx, certain 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 immediate medical attention if you notice blood in your stools, abdominal cramps, pain, diarrhoea, or weight loss. These may be signs of new or worsening inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Be alert for signs of infections and allergic reactions

Rarely, Bimzelx may cause serious infections. Speak to your doctor or seek immediate medical attention if you notice any signs of a serious infection. These signs are listed under “Serious adverse reactions” in section 4.

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

• difficulty breathing or swallowing.
• low blood pressure, which may cause dizziness or lightheadedness
• 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 given to 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 taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine. It is preferable 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 contraception while using this medicine and for at least 17 weeks after the last dose of Bimzelx.

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

Driving and using machines

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

Bimzelx contains polysorbate 80

This medicine contains 0.4 mg of polysorbate 80 in each ml of solution. Polysorbates 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”.

3. How to use Bimzelx

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much Bimzelx is administered and for how long

Plaque psoriasis

The recommended dose, administered as injections under the skin (“subcutaneous injections”), is as follows:

• 320 mg (administered in two pre-filled syringes containing 160 mg each) at weeks 0, 4, 8, 12, and 16.
• From week 16 onwards, you will use 320 mg (two pre-filled syringes containing 160 mg each) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue with injections every 4 weeks starting from week 16.

Psoriatic arthritis

The recommended dose, administered as an injection under the skin (“subcutaneous injection”), is as follows:

• 160 mg (administered in one pre-filled syringe containing 160 mg) every 4 weeks.
• If you have coexisting psoriatic arthritis and 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, administered as an injection under the skin (“subcutaneous injection”), is as follows:

• 160 mg (in one pre-filled syringe containing 160 mg) every 4 weeks.

Hidradenitis suppurativa

The recommended dose, administered as injections under the skin (“subcutaneous injections”), is as follows:

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

You and your doctor or nurse will decide whether you should inject this medicine yourself. Do not inject this medicine yourself unless a healthcare professional has trained you to do so. A caregiver may also administer the injections if they have been properly trained.

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

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 earlier than scheduled.

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

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

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

4. Possible adverse effects

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

Serious adverse effects

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

Possible serious infection – signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, persistent cough
• warmth, redness and pain in the skin, or a painful blistering rash

Your doctor will decide whether you can continue using Bimzelx.

Other adverse effects

Tell your doctor, pharmacist, or nurse if you experience any of the following adverse 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
• fungal skin infections, such as athlete’s foot between the toes
• ear infections
• cold sores (herpes simplex infections)
• stomach flu (gastroenteritis)
• inflammation of hair follicles, which may look like pimples
• headache
• itching, dry skin, or a rash resembling 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 levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• eye discharge with itching, redness, and swelling (conjunctivitis)
• blood in stools, cramps and abdominal pain, diarrhoea, or weight loss (signs of intestinal problems)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bimzelx

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

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

Bimzelx may be kept outside the refrigerator for up to 25 days. It must be kept in the outer packaging, at a temperature not exceeding 25 °C, and protected from direct light. Do not use the pre-filled syringes after this period. There is a space on the carton to write down the date when it was removed from the refrigerator.

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

6. Contents of the pack and other information

Composition of Bimzelx

• The active substance 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, polysorbate 80, and water for injections.

Appearance of Bimzelx and contents of the pack

Bimzelx is a liquid that ranges from clear to slightly opalescent. Its colour may vary from colourless to light yellowish brown. It is supplied in a single-use, disposable pre-filled syringe with a needle cap.

Bimzelx 160 mg solution for injection in pre-filled syringe is available in unit packs containing 1 or 2 pre-filled syringe(s), 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 certain 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

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium UCB Pharma S.A./NV Tel/Tel: + 32 / (0)2 559 92 00	Lithuania UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland)
	Luxembourg/Luxembourg UCB Pharma S.A./NV Tél/Tel: + 32 / (0)2 559 92 00 (Belgium/Belgium)
Czech Republic UCB s.r.o. Tel: + 420 221 773 411	Hungary UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
Denmark UCB Nordic A/S Tlf.: + 45 / 32 46 24 00	Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36
Germany UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848	Netherlands UCB Pharma B.V. Tel: + 31 / (0)76-573 11 40
Estonia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland)	Norway UCB Nordic A/S Tlf: + 47 / 67 16 5880
Greece UCB A.E. Tel: + 30 / 2109974000	Austria UCB Pharma GmbH Tel: + 43-(0)1 291 80 00
Spain UCB Pharma, S.A. Tel: + 34 / 91 570 34 44	Poland 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 (Pharmaceutical Products), Lda Tel: + 351 21 302 53000
Croatia Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46	Romania UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04
Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395	Slovenia Medis, d.o.o. Tel: + 386 1 589 69 00
Iceland Vistor hf. Tel: + 354 535 7000	Slovakia UCB s.r.o., organizational unit Tel: + 421 (0) 2 5920 2020
Italy UCB Pharma S.p.A. Tel: + 39 / 02 300 791	Finland/Finland UCB Pharma Oy Finland Tel/Tel: + 358 9 2514 4221
Cyprus Lifepharma (Z.A.M.) Ltd Tel: + 357 22 056300	Sweden UCB Nordic A/S Tel: + 46 / (0) 40 294 900
Latvia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland)

Date of the most recent revision of this leaflet:

Other sources of information

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

Instructions for use

Read the following instructions completely before using the Bimzelx 160 mg pre-filled syringe for injectable solution.

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

Important information:

• Your healthcare professional must show 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 trained to inject Bimzelx correctly.
• You and/or your caregiver must read these instructions before each use of Bimzelx.
• Contact 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 pre-filled syringe(s) of Bimzelx 160 mg. One pre-filled syringe is required for a 160 mg dose, and two pre-filled syringes (administered consecutively) are required for a 320 mg dose.
• Each pre-filled syringe is for single use (single-dose) only.
• The 160 mg pre-filled syringe has a needle safety feature. This will automatically cover the needle after the injection is complete. The needle safety feature helps prevent needlestick injuries to anyone handling the pre-filled syringe after injection.

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

• The expiry date (EXP) has passed.
• The packaging seal is broken.
• The pre-filled syringe has been dropped or appears damaged.
• The liquid has ever been frozen (even if it has been thawed).

For a more comfortable injection: Remove the pre-filled syringe(s) of Bimzelx 160 mg from the refrigerator and let it sit on a flat surface at room temperature for 30–45 minutes before injection.

• Do not heat them in any other way, such as in a microwave or with warm water.
• Do not shake the pre-filled syringe(s).
• Do not remove the cap from the pre-filled syringe(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, well-lit work surface, such as a table:

• 1 or 2 pre-filled syringe(s) 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 “Disposal 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 following sites may be used for injection:

• The stomach (abdomen) or thigh (see Figure B);

• The back of the upper 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 tender, 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 required for the prescribed dose (320 mg), a different injection site must be used 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. Allow the area to dry completely.
• Do not touch the cleaned area again before the injection.

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

• Make sure the name Bimzelx and the expiration date appear on the label.
• Check the medication through the viewing window. The medication should be from clear to slightly opalescent and free of particles. The color may vary from colorless to light yellowish brown. Air bubbles in the liquid may be visible. This is normal.
• Do not use the Bimzelx pre-filled syringe if the medication 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 grip with one hand. Pull the cap straight off the syringe with the other hand (see Figure E). You may see a drop of liquid at the needle tip; this is normal.

• Do not touch the needle or allow the needle to touch any surface.

• Do not press or hold the plunger rod while removing the cap. If the plunger rod is accidentally pulled out,

• discard the pre-filled syringe into a sharps disposal container and use a new one.

• Do not re-cap the needle. Doing so may damage the needle or cause accidental needlestick injury.

3b: With one hand, pinch and hold a fold of the cleaned skin. With the other hand, insert the needle into the skin at an approximate angle of 45 degrees

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

3c: Firmly push the plunger head to inject all the medication (see Figure G)

The medication has been fully injected when the plunger head can no longer be pushed (see Figure H).

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

• Press a dry cotton ball against 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 may cover the injection site with a bandage if needed.

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

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

If a second injection is prescribed by your doctor, use a new 160 mg Bimzelx pre-filled syringe and repeat steps 2–4.

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