Bimekizumab

Generic name: bimekizumab
Brand name: Bimzelx
Dosage form: single-dose prefilled syringe (160 mg/mL, 320 mg/2 mL), single-dose prefilled autoinjector (160 mg/mL, 320 mg/2 mL)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 30, 2024.

What is bimekizumab?

Bimekizumab (Bimzelx) is an interleukin inhibitor used to treat types of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nraxSpA to reduce inflammation and improve symptoms.  Bimekizumab works by targeting and blocking immune proteins called interleukin (IL-17A, IL-17F, and 17-AF) to reduce inflammation and improve symptoms of these conditions. 

Bimekizumab may be self-injected by the patient as a subcutaneous injection (under the skin) every 4 weeks initially, then every 8 weeks.

Bimekizumab FDA approval was received on October 18, 2023. FDA approval was based on positive results from three Phase 3 randomized clinical trials (BE READY, BE VIVID, and BE SURE) for plaque psoriasis. In these clinical trials, bimekizumab consistently and effectively improved plaque psoriasis with lasting levels of skin clearance. Since then, Bimekizumab FDA approval has been extended to cover other conditions. Bimekizumab brand name is Bimzelx from UCB, Inc.

What is Bimekizumab used for?

Bimekizumab FDA-approved indications are:

• plaque psoriasis (PSO) that is moderate to severe in adults who are candidates for systemic therapy or phototherapy.
• active psoriatic arthritis (PsA )in adults.
• active non-radiographic axial spondyloarthritis (nraxSpA) with objective signs of inflammation in adults.
• active ankylosing spondylitis in adults.

How does bimekizumab work?

Bimekizumab mechanism of action is as a monoclonal IgG1 antibody, a protein designed to attach to proteins called interleukin 17A (IL-17A) and interleukin 17F (IL-17F), which are both messenger molecules in the immune system. High levels of these interleukins have been shown to be involved in these autoimmune conditions. Bimekizumab attaches to IL-17A and IL-17F, reducing inflammation and improving condition symptoms.

How well does bimekizumab work?

In phase 3 clinical trials for plaque psoriasis, 59-68% of the bimekizumab patients had a complete clearance of psoriasis, and 85-91% of bimekizumab patients achieved clear or almost clear skin by week 16. Bimekizumab achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics (adalimumab, ustekinumab, and secukinumab) for psoriasis, with rapid responses lasting up to a year.

What is plaque psoriasis?

Plaque psoriasis is a red, scaly plaque with well-defined edges and a scale over the top, usually silvery white. In the skin folds, the plaques often appear shiny and have moist, peeling surfaces. Plaque psoriasis is often on the scalp, elbows, and knees but can affect any body part.

Plaque psoriasis results from an overactive immune system (autoimmune disease) and genetic and environmental factors. Immune factors and messenger proteins (inflammatory cytokines), including IL-17, increase inflammation and are involved in driving the psoriasis inflammatory processes.

Bimekizumab side effects

Common side effects

The most common side effects of bimekizumab affecting 1% or more patients include:

• upper respiratory tract infections
• headache
• cold sores (herpes simplex infections)
• small red bumps on your skin
• feeling tired
• fungal infections (oral thrush or fungal infections of the throat, skin, nails, feet or genitals)
• pain, redness, or swelling at the injection site
• stomach flu (gastroenteritis)
• acne.

Serious bimekizumab side effects

Also, see the "Warnings" section below.

Other serious side effects include:

Elevated liver enzyme levels. Your healthcare provider will do blood tests to check your liver enzyme levels before starting treatment and during treatment with this medicine. If you develop liver problems, your healthcare provider may pause or permanently stop your treatment with this medicine. Call your healthcare provider right away if you develop any signs or symptoms of liver problems, including pain on the right side of your stomach area, feeling very tired, reduced appetite, nausea and vomiting, itchy skin, dark urine, light-colored bowel motions, yellowing of your skin or the whites of your eyes.

Inflammatory bowel disease. New cases of inflammatory bowel disease or "flare-ups" have happened in patients taking this medicine. If you also have inflammatory bowel disease (Crohn's disease or ulcerative colitis), tell your healthcare provider if you have worsening disease symptoms or develop new symptoms of stomach pain or diarrhea during treatment with this medicine. If you develop new or worsening signs of Crohn's disease or ulcerative colitis, your healthcare provider will stop treatment with bimekizumab.

These are not all of the possible side effects of Bimzelx.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Bimekizumab may increase your risk of having serious side effects, including:

Suicidal thoughts and behavior

Suicidal thoughts and behavior have happened in some people treated with this medicine. Get medical help right away or call the National Suicide and Crisis Lifeline at 988 if you, your caregiver, or your family member notices in you any of the following symptoms:

• new or worsening depression or anxiety
• thoughts of suicide, dying, or hurting yourself
• changes in behavior or mood
• acting on dangerous impulses
• attempt to commit suicide.

Infections

Bimekizumab may lower the ability of your immune system to fight infections and, therefore, may increase your risk of infections.

• Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with this medicine.
• If your healthcare provider feels you are at risk for TB, you may be treated with medicine for TB before you begin treatment and during your treatment with this injection.
• Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Bimzelx. Do not take this medicine if you have an active TB infection. 

Before starting bimekizumab, tell your healthcare provider if you:

• are being treated for an infection;
• have an infection that does not go away or keeps coming back
• have TB or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection with symptoms such as fever, sweats, or chills, muscle aches, cough, shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body that is different from your psoriasis, diarrhea or stomach pain, or burning when you urinate or urinating more often than normal.

After starting bimekizumab, call your healthcare provider right away if you have any of the signs of infection listed above. Do not use this medicine if you have any signs of infection unless you are instructed to by your healthcare provider. See "Bimzelx side effects" for more information about side effects.

Before using this medicine

Before using this injection, tell your healthcare provider about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before using bimekizumab, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "Warnings"
• have a history of depression, or suicidal thoughts or behavior
• have liver problems - your doctor will test your liver enzymes, alkaline phosphatase, and bilirubin before starting treatment
• have inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with bimekizumab. Tell all your healthcare providers you are being treated with bimekizumab before receiving a vaccine.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as it is not known if bimekizumab can harm your unborn baby.

If you become pregnant while taking bimekizumab, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about your and your baby's health. Talk to your healthcare provider or call 1-877-311-8972 to enroll in this registry.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed, as it is not known if bimekizumab passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

Tell your healthcare provider about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use bimekizumab?

Read the detailed "Instructions for Use" that comes with your bimekizumab injections for information on how to prepare and inject a dose and how to properly throw away (dispose of) used autoinjectors and prefilled syringes. Bimzelx should be used under the guidance and supervision of a healthcare professional. Patients may self-inject after training in subcutaneous injection technique. Use bimekizumab precisely as prescribed by your healthcare provider.

Before injecting, remove the carton from the refrigerator and allow bimekizumab to reach room temperature (30 to 45 minutes). Do not remove the prefilled syringes or autoinjectors from the carton to protect from light.

If the solution and container permit, check the injection solution for particulate matter and discoloration before administration. Do not use if the solution contains visible particles, is discolored or is cloudy.

Bimekizumab administration instructions

• Bimekizumab is a subcutaneous injection (given under the skin) that can be injected into the thigh, abdomen, or back of the upper arm.
• Bimekizumab should only be administered into the upper outer arm by a healthcare professional or caregiver.
• Do not inject within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
• For each dose, bimekizumab is given as 2 subcutaneous injections of 160 mg each; each injection should be given in different locations.
• Discard the syringes or autoinjectors after use. Do not reuse.

Dosing information

Usual adult bimekizumab dose: 320 mg given at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.

For patients weighing 120 kg or over, you healthcare professional may consider a dosage of 320 mg every 4 weeks after Week 16.

Bimekizumab is available as:

• single-dose prefilled syringe 160 mg/mL
• single-dose prefilled autoinjector 160 mg/mL
• single-dose prefilled syringe 320 mg/2 mL
• single-dose prefilled autoinjector 320 mg/2 mL.

Related/similar drugs

Otezla, Sotyktu, Cimzia, prednisone, naproxen, Humira, Rinvoq, adalimumab, Enbrel, Tremfya

What happens if I miss a dose?

If you miss your prescribed dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.

Storage

• Store in the refrigerator between 36°F to 46°F (2°C to 8oC).
• Bimzelx may be stored at room temperature up to 77°F (25°C) for up to 30 days in the original carton.
• Do not place prefilled syringes or autoinjectors back in the refrigerator after they have been stored at room temperature.
• Write the date removed from the refrigerator in the space provided on the carton and throw away if injections have been kept at room temperature and not been used within 30 days.

Ingredients

Active ingredient: bimekizumab-bkzx

Bimzelx inactive ingredients: glacial acetic acid, glycine, polysorbate 80, sodium acetate, and Water for Injection, USP.

Company

Manufactured by: UCB, Inc., 1950 Lake Park Drive Smyrna, GA 30080.

Bimekizumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for bimekizumab.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer