Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Bimzelx 320 mg solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Bimekizumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 condition called plaque psoriasis. Bimzelx reduces the symptoms, including pain, itching, and scaling of the skin. Psoriatic arthritis Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints, often accompanied by plaque psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough or in case of intolerance, you will be given Bimzelx either alone or in combination with another medicine called methotrexate. Bimzelx reduces inflammation and can therefore help to reduce pain, stiffness, swelling in and around your joints, psoriatic skin rash, psoriatic nail damage and slow down the damage to the cartilage and bone of the joints involved in the disease. These effects can help you to control signs and symptoms of the disease, ease your normal daily activities, reduce tiredness, and improve your quality of life. Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis) 1
Bimzelx is used to treat adults with an inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints, called axial spondyloarthritis. If the condition is not visible using X-rays, it is referred to as "non-radiographic axial spondyloarthritis"; if it occurs in patients with visible signs on X-rays, it is referred to as "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, reduce inflammation and improve your physical function. Bimzelx can help to reduce back pain, stiffness and tiredness, which can ease your normal daily activities and improve your quality of life. Hidradenitis suppurativa Bimzelx is used in adults to treat a condition called hidradenitis suppurativa (sometimes called acne inversa or Verneuil's disease). Hidradenitis suppurativa is a chronic inflammatory skin disease that causes painful lesions like tender nodules (lumps) and abscesses (boils), and lesions that may leak pus. It most commonly affects specific areas of the skin such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas. You will first be given other medicines. If you do not respond well enough to these medicines, you will be given Bimzelx. Bimzelx reduces the inflammatory nodules (lumps), abscesses (boils), and lesions that may leak 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 (IL) inhibitors. Bimekizumab works by reducing the activity of two proteins called IL-17A and IL-17F, which are involved in causing inflammation. There are higher levels of these proteins in inflammatory diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa. 2.
What you need to know before you take it
e 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, including tuberculosis (TB), which your doctor thinks is important. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Bimzelx if: • you have an infection or an infection that keeps coming back. • you recently had or plan to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Bimzelx. • 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 tell your doctor or get medical help immediately if you notice blood in the stool, abdominal cramps, pain, diarrhoea or weight loss. These may be signs of new or worsening inflammatory bowel disease (Crohn's disease or ulcerative colitis). Look out for infections and allergic reactions Bimzelx can rarely cause serious infections. Talk to your doctor or get medical help immediately if you notice any signs of a serious infection. Such signs are listed under "Serious side effects" in section 4.
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Bimzelx can potentially cause serious allergic reactions. Talk to your doctor or get medical help immediately if you notice any signs of a serious allergic reaction. Such signs may include: • difficulty breathing or swallowing • low blood pressure, which can make you dizzy or light-headed • swelling of the face, lips, tongue or throat • severe itching of the skin, with a red rash or raised bumps. Children and adolescents Do not give this medicine to children and young people under 18 years of age. This is because it has not yet been adequately 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, breast-feeding and fertility If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. It is preferable to avoid the use of Bimzelx in pregnancy. This is because it is not known how this medicine will affect the baby. If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 17 weeks after your last dose of Bimzelx. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you can breast-feed or use Bimzelx. Driving and using machines Bimzelx is unlikely to affect your ability to drive and use machines. Bimzelx contains polysorbate 80 This medicine contains 0.4 mg of polysorbate 80 in each 1 mL solution. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. Bimzelx contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially "sodium free". 3.
How to use Bimzelx
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How to take it
and for how long Plaque psoriasis The recommended dose, given as an injection under your skin ('subcutaneous injection') is as follows: • 320 mg (given as one pre-filled pen containing 320 mg) at weeks 0, 4, 8, 12, 16. • From week 16, you will use 320 mg (one pre-filled pen containing 320 mg) every 8 weeks. If you weigh more than 120 kg, your doctor may decide to continue your injections every 4 weeks from week 16. Psoriatic arthritis The recommended dose, given as an injection under your skin ('subcutaneous injection') is as follows: • 160 mg every 4 weeks. • If you have psoriatic arthritis with coexistent moderate to severe plaque psoriasis, the recommended dose regimen is the same as for plaque psoriasis. After week 16, your doctor may 3
adapt your injections to 160 mg every 4 weeks, depending on your joint symptoms. Other pharmaceutical forms /strengths are available for administration of the 160 mg dose. Axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis) The recommended dose, given as an injection under your skin ('subcutaneous injection') is as follows: • 160 mg every 4 weeks. Other pharmaceutical forms/strengths are available for administration of the 160 mg dose. Hidradenitis suppurativa The recommended dose, given as an injection under your skin ('subcutaneous injection') is as follows: • 320 mg (given as one pre-filled pen containing 320 mg) every 2 weeks until week 16. • From week 16, you will use 320 mg (one pre-filled pen containing 320 mg) every 4 weeks. You and your doctor or nurse will decide if you should inject this medicine yourself. Do not inject this medicine unless you have been trained by a healthcare professional. A caregiver may also give your injections after they have been trained. Read the 'Instructions for use' at the end of this leaflet before injecting Bimzelx 320 mg solution for injection in pre-filled pen 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 your dose earlier than you should. 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 you stop using Bimzelx. If you stop treatment, your symptoms may come back. If you have any further questions on 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 get medical help immediately if you get any of the following side effects: Possible serious infection – the signs may include: • fever, flu-like symptoms, night sweats • feeling tired or short of breath, cough which will not go away • warm, red and painful skin, or a painful skin rash with blisters Your doctor will decide if you can keep using Bimzelx. Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects: Very common (may affect more than 1 in 10 people) • upper respiratory infections with symptoms such as sore throat and stuffy nose Common (may affect up to 1 in 10 people) 4
• • • • • • • • • • • •
thrush in the mouth or throat with symptoms such as white or yellow patches; red or sore mouth and pain with swallowing fungal infection of the skin, such as athlete's foot between the toes ear infections cold sores (herpes simplex infections) stomach flu (gastroenteritis) inflamed hair follicles which may look like pimples headache itchy, dry skin or an eczema-like rash sometimes with swollen and reddened skin (dermatitis) acne redness, pain or swelling and bruising at the site of injection feeling tired fungal infection of the vulvovaginal area (vaginal thrush)
Uncommon (may affect up to 1 in 100 people) • lowered levels of white blood cells (neutropenia) • fungal infections of the skin and mucous membranes (including oesophageal candidiasis) • discharge from the eye with itching, redness and swelling (conjunctivitis) • blood in the stool, abdominal cramps and pain, diarrhoea or weight loss (signs of bowel problems) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
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 that month. Store in a refrigerator between 2 °C and 8 °C. Do not freeze. Keep the pre-filled pens in the original carton in order to protect from light. Bimzelx can be kept out of the refrigerator for up to 25 days. This must be in the outer carton, not above 25 °C and away from direct light. Do not use the pre-filled pens after this time period. There is a space on the box so you can write the date it was taken out of the refrigerator. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What Bimzelx contains • The active substance is bimekizumab. Each pre-filled pen contains 320 mg of bimekizumab in the 2 mL solution. • The other ingredients are glycine, sodium acetate trihydrate, glacial acetic acid, polysorbate 80 and water for injections (see section 2 "Bimzelx contains polysorbate 80" and "Bimzelx contains sodium"). What Bimzelx looks like and contents of the pack Bimzelx is a clear to slightly opalescent liquid. Its colour may vary from colourless to pale brownishyellow. It comes in a single use disposable pre-filled pen. Bimzelx 320 mg solution for injection in pre-filled pen is available in unit packs containing 1 prefilled pen and in multipacks comprising 3 cartons, each containing 1 pre-filled pen. Not all pack sizes may be marketed. Marketing Authorisation Holder UCB Pharma Limited 208 Bath Road Slough Berkshire SL1 3WE, United Kingdom. Manufacturer UCB Pharma S.A. Chemin du Foriest B-1420 Braine-l'Alleud, Belgium This leaflet was last revised in 03/2026
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Instructions for use Read all the instructions below before you use Bimzelx 320 mg solution for injection in pre-filled pen. Bimzelx 320 mg pre-filled pen at a glance (see Figure A):
Important information: • • • •
Your healthcare professional should show you how to prepare and inject Bimzelx using the 320 mg pre-filled pen. Do not inject yourself or someone else until you have been shown how to inject Bimzelx the right way. You and/or your caregiver should read these Instructions for Use before each use of Bimzelx. Call your healthcare professional if you or your caregiver have any questions about how to inject Bimzelx the right way. Each pre-filled pen is for one-time (single-dose) use only.
Do not use this medicine and return it to the pharmacy if: • • • •
the expiry date (EXP) has passed. the carton seal is broken. the pre-filled pen has been dropped or looks damaged. the liquid has ever been frozen (even if thawed).
For a more comfortable injection: Take the 320 mg pre-filled pen out of the refrigerator and let it sit on a flat surface at room temperature in its original carton for 30 to 45 minutes before injecting. • • •
Do not warm in any other way, such as in a microwave or in hot water. Do not shake the pre-filled pen. Do not uncap the pre-filled pen until you are ready to inject.
Follow the steps below each time you use Bimzelx. Step 1: Setting up for your injection Place the following items on a clean flat, well-lit work surface, like a table: •
1 Bimzelx 320 mg pre-filled pen
You will also need (not included in the carton): 7
• • •
1 alcohol wipe 1 clean cotton ball 1 sharps disposal container. See "Throw away the used Bimzelx pre-filled pen" at the end of these Instructions for Use.
Step 2: Choose injection site and prepare your injection 2a: Choose your injection site • The places you may choose for your injection are: o your stomach (abdomen) or your thigh (see Figure B). o the back of your arm (see Figure C). Bimzelx may be injected into the back of your arm by a healthcare professional or caregiver only.
• • •
Do not inject into areas where the skin is tender, bruised, red, scaly, hard or areas with scars or stretch marks. Do not inject within 5 cm of the belly-button (navel). You should choose a different place each time you give yourself an injection.
2b: Wash your hands well with soap and water and dry with a clean towel 2c: Prepare your skin • Clean the injection site with an alcohol wipe. Let the area dry completely. Do not touch the cleaned area again before injecting. 2d: Check the pre-filled pen (see Figure D) • Make sure the name Bimzelx and expiry date appear on the label. • Check the medicine through the viewing window. The medicine should be clear to slightly opalescent and free of particles. Its colour may vary from colourless to pale 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, discoloured, or has particles.
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Step 3: Inject Bimzelx 3a: Remove the pre-filled pen cap • Hold the pre-filled pen firmly with one hand around the handle. Pull the cap straight off the prefilled pen with the other hand (see Figure E). Although you cannot see the needle tip, it is now uncovered. • Do not touch the needle guard or put the cap back on. This is because it could activate the prefilled pen and you could prick 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 your skin, then firmly press the pre-filled pen down against your skin • You will hear a click sound. Your injection begins when the first "click" is heard (see Figure G). Do not lift the pre-filled pen away from the skin.
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3d: Keep holding the pre-filled pen in place and pressed firmly against your skin. It will take about 20 seconds to receive your full dose. • You will hear a second "click" that tells you that the injection is almost complete. You will see the yellow colour indicator filling the viewing window (see Figure H).
After the second click, continue to hold down the pre-filled pen for an additional 5 seconds (slowly count to 5). This will ensure you receive your full dose (see Figure I).
•
5s
3e: Remove the pre-filled pen by carefully pulling it straight up from your skin. The needle guard will automatically cover the needle • Press a dry cotton ball over 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 small adhesive plaster, if needed.
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Step 4: Throw away the used Bimzelx pre-filled pen Put the used pre-filled pen in a sharps disposal container straight away after use (see Figure J).
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Frequently asked questions about Bimzelx 320 mg solution for injection in pre-filled pen
How do I take Bimzelx 320 mg solution for injection in pre-filled pen?
Bimzelx 320 mg solution for injection in pre-filled pen comes as injection containing 320mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Bimzelx 320 mg solution for injection in pre-filled pen?
The active substance in Bimzelx 320 mg solution for injection in pre-filled pen is bimekizumab.
Are there equivalent medicines to Bimzelx 320 mg solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: Bimzelx 320 mg solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Bimzelx 320 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Bimzelx 320 mg solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: bimekizumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Plaque psoriasis
Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic arthritis
Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
Hidradenitis suppurativa (HS)
Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy (see section 5.1).
4.2. Posology and method of administration
This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated.
Posology
Plaque psoriasis
The recommended dose for adult patients with plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter.
Psoriatic arthritis
The recommended dose for adult patients with active psoriatic arthritis is 160 mg (given as 1 subcutaneous injection of 160 mg) every 4 weeks.
For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, the recommended dose is the same as for plaque psoriasis [320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter]. After 16 weeks, regular assessment of efficacy is recommended and if a sufficient clinical response in joints cannot be maintained, a switch to 160 mg every 4 weeks can be considered.
Axial spondyloarthritis (nr-axSpA and AS)
The recommended dose for adult patients with axial spondyloarthritis is 160 mg (given as 1 subcutaneous injection of 160 mg) every 4 weeks.
Hidradenitis suppurativa
The recommended dose for adult patients with hidradenitis suppurativa is 320 mg (given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg) every 2 weeks up to week 16 and every 4 weeks thereafter.
For above indications, consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.
Special populations
Overweight patients with plaque psoriasis
For some patients with plaque psoriasis (including psoriatic arthritis with coexistent moderate to severe psoriasis) and a body weight ≥120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response (see section 5.1).
Elderly (≥65 years)
No dose adjustment is required (see section 5.2).
Renal or hepatic impairment
Bimekizumab has not been studied in these patient populations. Dose adjustments are not considered necessary based on pharmacokinetics (see section 5.2).
Paediatric population
The safety and efficacy of bimekizumab in children and adolescents below the age of 18 years have not yet been established. No data are available.
Method of administration
This medicinal product is administered by subcutaneous injection. A 320 mg dose can be given as 2 subcutaneous injections of 160 mg or 1 subcutaneous injection of 320 mg.
Suitable areas for injection include thigh, abdomen and upper arm. Injection sites should be rotated and injections should not be given into psoriasis plaques or areas where the skin is tender, bruised, erythematous, or indurated. Administration in the upper arm may only be performed by a healthcare professional or caregiver.
The pre-filled syringe or pre-filled pen must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Bimzelx with a pre-filled syringe or pre-filled pen if their physician determines that it is appropriate and with medical follow-up as necessary. Patients should be instructed to inject the full amount of Bimzelx according to the instructions for use provided in the package leaflet.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Infections
Bimekizumab may increase the risk of infections such as upper respiratory tract infections and oral candidiasis (see section 4.8).
Caution should be exercised when considering the use of bimekizumab in patients with a chronic infection or a history of recurrent infection. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated (see section 4.3).
Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection, the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves.
Pre-treatment evaluation for tuberculosis (TB)
Prior to initiating treatment with bimekizumab, patients should be evaluated for TB infection. Bimekizumab should not be given in patients with active TB (see section 4.3). Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating bimekizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Inflammatory bowel disease
Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab (see section 4.8). Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.
Hypersensitivity
Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.
Vaccinations
Prior to initiating therapy with bimekizumab, completion of all age-appropriate immunisations according to current immunisation guidelines should be considered.
Live vaccines should not be given in patients treated with bimekizumab.
Patients treated with bimekizumab may receive inactivated or non-live vaccinations. Healthy individuals who received a single 320 mg dose of bimekizumab two weeks prior to vaccination with an inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive bimekizumab prior to vaccination.
Excipients with known effect
Polysorbate 80
This medicinal product contains 0.4 mg of polysorbate 80 in each 1 mL solution. Polysorbates may cause allergic reactions.
Sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium free”.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
There is no direct evidence for the role of IL-17A or IL-17F in the expression of CYP450 enzymes. The formation of some CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation. Thus, anti-inflammatory treatments, such as with the IL-17A and IL-17F inhibitor bimekizumab, may result in normalisation of CYP450 levels with accompanying lower exposure of CYP450-metabolised medicinal products. Therefore, a clinically relevant effect on CYP450 substrates with a narrow therapeutic index, in which the dose is individually adjusted (e.g. warfarin) cannot be excluded. On initiation of bimekizumab therapy in patients being treated with these types of medicinal products, therapeutic monitoring should be considered.
Population pharmacokinetic (PK) data analyses indicated that concomitant administration of conventional disease modifying antirheumatic drugs (cDMARDs) including methotrexate or prior exposure to biologics have no clinically relevant impact on the clearance of bimekizumab.
Live vaccines should not be given concurrently with bimekizumab (see section 4.4).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
Pregnancy
There is a limited amount of data on the use of bimekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Bimzelx during pregnancy.
Breast-feeding
It is unknown whether bimekizumab is excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bimzelx therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
The effect of bimekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Bimzelx has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS respectively).
Tabulated list of adverse reactions
Adverse reactions from clinical studies and post-marketing reports (Table 1) are classified by MedDRA System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
A total of 5862 patients have been treated with bimekizumab in blinded and open-label clinical studies in plaque psoriasis (PSO), psoriatic arthritis (PsA), axial spondyloarthritis (nr-axSpA and AS) and hidradenitis suppurativa (HS) representing 11468.6 patient-years of exposure. Of these, over 4660 patients were exposed to bimekizumab for at least one year. Overall, the safety profile of bimekizumab is consistent across all indications.
Table 1: List of adverse reactions
System Organ Class
Frequency
Adverse reaction
Infections and infestations
Very common
Upper respiratory tract infections
Common
Oral candidiasis,
Tinea infections,
Ear infections,
Herpes simplex infections,
Oropharyngeal candidiasis,
Gastroenteritis,
Folliculitis,
Vulvovaginal mycotic infection (including vulvovaginal candidiasis)
Uncommon
Mucosal and cutaneous candidiasis (including oesophageal candidiasis),
Conjunctivitis
Blood and lymphatic system disorders
Uncommon
Neutropenia
Nervous system disorders
Common
Headache
Gastrointestinal disorders
Uncommon
Inflammatory bowel disease
Skin and subcutaneous tissue disorders
Common
Rash, dermatitis and eczema,
Acne
General disorders and administration site conditions
Common
Injection site reactionsa,
Fatigue
a) Includes: injection site erythema, reaction, oedema, pain, swelling, haematoma.
Description of selected adverse reactions
Infections
In the placebo-controlled period of Phase III clinical studies in plaque psoriasis, infections were reported in 36.0% of patients treated with bimekizumab for up to 16 weeks compared with 22.5% of patients treated with placebo. Serious infections occurred in 0.3% of patients treated with bimekizumab and 0% treated with placebo.
The majority of infections consisted of non-serious mild to moderate upper respiratory tract infections such as nasopharyngitis. There were higher rates of oral and oropharyngeal candidiasis in patients treated with bimekizumab consistent with the mechanism of action (7.3% and 1.2% respectively compared to 0% for placebo-treated patients). More than 98% of cases were non-serious, mild or moderate in severity, and did not require treatment discontinuation. A slightly higher incidence of oral candidiasis was reported in patients <70 kg (8.5% versus 7.0% in patients ≥70 kg).
Over the entire treatment period of Phase III studies in plaque psoriasis, infections were reported in 63.2% of patients treated with bimekizumab (120.4 per 100 patient-years). Serious infections were reported in 1.5% of patients treated with bimekizumab (1.6 per 100 patient-years) (see section 4.4).
Infection rates observed in PsA and axSpA (nr-axSpA and AS) Phase III clinical studies were similar to those observed in plaque psoriasis apart from oral and oropharyngeal candidiasis rates in patients treated with bimekizumab, which were lower at 2.3% and 0% respectively in PsA and 3.7% and 0.3% respectively in axSpA compared to 0% with placebo.
Infection rates observed in HS Phase III clinical studies were similar to those observed in other indications. In the placebo-controlled period, oral and oropharyngeal candidiasis rates in patients treated with bimekizumab were 7.1% and 0% respectively compared to 0% with placebo.
Neutropenia
Neutropenia was observed with bimekizumab in Phase III clinical studies in plaque psoriasis. Over the entire treatment period of Phase III studies, neutropenia grade 3/4 were observed in 1% of patients treated with bimekizumab.
The frequency of neutropenia in PsA, axSpA (nr-axSpA and AS) and HS clinical studies was similar to that observed in plaque psoriasis studies.
More than 80% of the cases were transient and did not require treatment discontinuation. No serious infections were associated with neutropenia.
Hypersensitivity
Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors (see section 4.4).
Immunogenicity
Plaque psoriasis
Approximately 45% of plaque psoriasis patients treated with bimekizumab up to 56 weeks at the recommended dosing regimen (320 mg every 4 weeks up to week 16 and 320 mg every 8 weeks thereafter) developed anti-drug antibodies. Of the patients who developed anti-drug antibodies, approximately 34% (16% of all patients treated with bimekizumab) had antibodies that were classified as neutralising.
Psoriatic arthritis
Approximately 31% of patients with psoriatic arthritis treated with bimekizumab at the recommended dosing regimen (160 mg every 4 weeks) up to 16 weeks had anti-drug antibodies. Of the patients with anti-drug antibodies, about 33% (10% of all patients treated with bimekizumab) had antibodies that were classified as neutralising. By week 52, approximately 47% of biologic disease-modifying anti-rheumatic drug (bDMARD) treatment naïve patients with psoriatic arthritis in the BE OPTIMAL study treated with bimekizumab at the recommended dosing regimen (160 mg every 4 weeks) had anti-drug antibodies. Of the patients with anti-drug antibodies, about 38% (18% of all patients in the BE OPTIMAL study treated with bimekizumab) had antibodies that were classified as neutralising.
Axial spondyloarthritis (nr-axSpA and AS)
Approximately 57% of patients with nr-axSpA treated with bimekizumab up to 52 weeks at the recommended dosing regimen (160 mg every 4 weeks) had anti-drug antibodies. Of the patients with anti-drug antibodies, approximately 44% (25% of all patients treated with bimekizumab) had antibodies that were classified as neutralising.
Approximately 44% of patients with AS treated with bimekizumab up to 52 weeks at the recommended dosing regimen (160 mg every 4 weeks) had anti-drug antibodies. Of the patients with anti-drug antibodies, approximately 44% (20% of all patients treated with bimekizumab) had antibodies that were classified as neutralising.
Hidradenitis suppurativa
Approximately 59% of HS patients treated with bimekizumab up to 48 weeks at the recommended dosing regimen (320 mg every 2 weeks up to week 16 and 320 mg every 4 weeks thereafter) developed anti-drug antibodies. Of the patients who developed anti-drug antibodies, approximately 63% (37% of all patients treated with bimekizumab) had antibodies that were classified as neutralising.
Across indications, no clinically meaningful impact on clinical response was associated with anti-bimekizumab antibodies development, and an association between immunogenicity and treatment emergent adverse events has not been clearly established.
Elderly patients (≥65 years)
Exposure is limited in elderly subjects.
Elderly patients may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.
In the placebo-controlled period of Phase III clinical studies in plaque psoriasis, oral candidiasis was observed in 18.2% of patients ≥65 years versus 6.3% in <65 years, dermatitis and eczema in 7.3% of patients ≥65 years versus 2.8% in <65 years.
In the placebo-controlled period of Phase III clinical studies in psoriatic arthritis, oral candidiasis was observed in 7.0% of patients ≥65 years versus 1.6% in <65 years, dermatitis and eczema in 1.2% of patients ≥65 years versus 2.0% in <65 years.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Single doses of 640 mg intravenously or 640 mg subcutaneously, followed by 320 mg subcutaneously every two weeks for five doses have been administered in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs and symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
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