Bimzelx 160 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bimzelx 160 mg solution for injection in pre-filled pen

bimekizumab

This medicinal product is subject to additional monitoring, which will enable rapid identification 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 all of this 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to 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 medications. If these medications 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 normal 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 primarily 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 medications. If you do not respond sufficiently 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 may help reduce back pain, stiffness, and fatigue, which may make your normal 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 acne inversa 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 medications. If your response to these medications 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 driving 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 ingredients 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 Bimzelx if:

• You have an infection or an infection that keeps recurring.
• You have recently been vaccinated or plan 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 help if you notice blood in your stools, abdominal cramps, pain, diarrhea, 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

In rare cases, Bimzelx may cause serious infections. Speak to your doctor or seek immediate medical help 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 help 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.
• Severe itching of the skin, with a red rash or lumps.

Children and adolescents

This medicine should 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 unknown how this medicine may 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 operate machinery.

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; therefore, it is essentially “sodium-free”.

3. How to use Bimzelx

Plaque psoriasis

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

How much Bimzelx is administered and for how long

• The recommended dose, administered as injections under the skin ("subcutaneous injections"), is as follows:
• 320 mg (administered in two pre-filled pens with 160 mg each) at weeks 0, 4, 8, 12, and 16.
• Starting 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 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 pen containing 160 mg) every 4 weeks.
• If you have psoriatic arthritis coexisting with moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis. After week 16, your doctor may adjust your 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 via a subcutaneous injection, is 160 mg (in one pre-filled pen containing 160 mg) every 4 weeks.

Hidradenitis suppurativa

The recommended dose, administered as subcutaneous injections, is as follows:

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

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

Read the "Instructions for use" at the end of this leaflet before injecting the Bimzelx 160 mg pre-filled pen 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 earlier than scheduled.

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 the use of Bimzelx. If you stop treatment, your 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

Inform your doctor or seek immediate medical help 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 rash with blisters

Your doctor will decide whether you can continue using Bimzelx.

Other adverse effects

Inform 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 an eczema-like rash, sometimes with swollen and
• red skin (dermatitis)
• 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 levels of white blood cells (neutropenia)
• fungal infections of the skin and mucous membranes (including esophageal 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 included 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 the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and packaging following 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 pens in their original carton to protect them from light.

Bimzelx may be kept outside the refrigerator for a maximum of 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 pens after this period. There is a space on the carton to write 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 any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Bimzelx

• The active substance 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 injections.

What Bimzelx looks like and contents of the pack

Bimzelx is a liquid, from transparent to slightly opalescent. Its colour may vary from colourless to light yellowish brown. It is supplied 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 pen(s), 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 certain pack sizes may be marketed.

Marketing Authorisation Holder

UCB Pharma S.A.

Allée de la Recherche 60

B-1070 Bruxelles, 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 Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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 in full 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 must teach you how to prepare and inject Bimzelx using the 160 mg pre-filled pen. 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 correctly inject Bimzelx.
• Depending on the prescribed dose, you must use 1 or 2 pre-filled pen(s) of Bimzelx 160 mg. One pre-filled pen is required for a 160 mg dose, and two pre-filled pens (administered consecutively) are required for a 320 mg dose.
• Each pre-filled pen is for single use (single-dose) only.

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 pen has been dropped or appears damaged.
• The liquid has ever been frozen (even if it has since thawed).

For a more comfortable injection: Remove the 160 mg pre-filled pen(s) from the refrigerator and leave them 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 pen(s).
• Do not remove the cap from the pre-filled pen(s) until you are ready for injection.

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 pre-filled pen(s) of Bimzelx 160 mg

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

• 1 or 2 alcohol swab(s)
• 1 or 2 clean cotton ball(s)
• 1 sharps container for disposal of used needles and syringes. See “Disposal of used Bimzelx pre-filled pen” at the end of these instructions.

Step 2: Choose the injection site and prepare for injection

2a: Choose the injection site

• Injection sites you may use include:
  • 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 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 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 swab. Allow the area to dry completely. Do not touch the cleaned area before injection.

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

• Ensure that the name Bimzelx and the expiry date are visible on the label.
• Check the medication through the viewing window. The solution should be from clear to slightly opalescent and free of particles. The colour may vary from colourless to light yellowish brown. Air bubbles in the liquid may be visible. This is normal.
• Do not use the Bimzelx pre-filled pen if the solution is cloudy, has changed colour, or contains particles.

Step 3: Inject Bimzelx

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

• Hold the pre-filled pen firmly by the grip with one hand. Pull the cap straight off 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 could activate the pre-filled pen and result in accidental needle stick.

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 begins 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 pressed firmly against the skin

• You will hear a second “click” 15 seconds after the first click.
• The second click indicates that the full dose has been injected and the Bimzelx injection is complete. You should see the yellow indicator completely fill the viewing window (see Figure H).

3e: Remove the pre-filled pen by carefully pulling it away from 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. Mild bleeding or a drop of liquid may occur. This is normal. You may cover the injection site with a plaster if needed.

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

Immediately after use, place the used pre-filled pen into a sharps disposal container (see Figure I).

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

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