Bimzelx

Pronunciation: Bim zel’ ex
Generic name: bimekizumab
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 Nov 26, 2024.

What is Bimzelx?

Bimzelx  (bimekizumab) is a biologic medicine used to treat types of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nraxSpA) and hidradenitis suppurativa (HS). Bimzelx works by targeting and blocking immune proteins called interleukin (IL-17A, IL-17F, and 17-AF) to reduce inflammation and improve symptoms of plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, AS, and nraxSpA.

Bimzelx is a subcutaneous injection that may be self-injected by the patient under the skin every 2 to 4 weeks initially, depending on the condition treated, which may be extended to every 8 weeks for plaque psoriasis in some patients.

Bimzelx FDA approval was first received for plaque psoriasis on October 18, 2023. Approval was based on positive results from three Phase 3 randomized clinical trials (BE READY, BE VIVID, and BE SURE). Bimzelx consistently and effectively improved plaque psoriasis with lasting levels of skin clearance. Bimzelx FDA approval was extended to include psoriatic arthritis, ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nraxSpA) on September 23, 2024. Bimzelx FDA approval was granted for hidradenitis suppurativa (HS) on November 19, 2024,  after positive results from two Phase 3 studies, BE HEARD I and BE HEARD II. Bimzelx achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.

What is Bimzelx used for?

Bimzelx is FDA-approved to treat:

• 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
• moderate to severe hidradenitis suppurativa (HS) in adults.

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.

How does Bimzelx work?

Bimzelx's mechanism of action is as an interleukin-17A and F antagonist; it attaches to interleukin 17A, IL 17F, and IL-17AF, which are messenger proteins in the immune system. High levels of these proteins have been shown to be involved in these conditions. When Bimzelx attaches to IL-17A, IL-17F, and IL-17AF, it prevents the release of inflammatory substances in the body, which helps reduce inflammation and symptoms of these conditions. Bimzelx (bimekizumab-bkzx) is from a class of medicines called interleukin inhibitors.

How well does Bimzelx work?

In phase 3 clinical trials, 59-68% of the Bimzelx patients had a complete clearance of psoriasis, and 85-91% of Bimzelx patients achieved clear or almost clear skin by week 16. Bimzelx 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.

Bimzelx side effects

Common side effects

When used for psoriasis the most common Bimzelx side effects are headache, feeling tired (fatigue), cold sores (herpes simplex infections), upper respiratory tract infections, small red bumps on your skin (folliculitis), acne, stomach flu (gastroenteritis), pain, redness, or swelling at the injection site, and fungal infections (oral thrush or fungal infections of the throat, skin, nails, feet or genitals). These side effects occur in 1% or more patients who use this medicine.

When used for psoriatic arthritis, the most common Bimzelx side effects are a blocked nose, sneezing, and sore throat, which are symptoms of an upper respiratory tract infection, oral thrush (candidiasis), headache, diarrhea, and urinary tract infection. These side effects occur in 2% or more of patients who use this medicine.

When used for non-radiographic axial spondyloarthritis, the most common Bimzelx side effects are sore throat, stuffy nose, and sneezing, which are symptoms of throat upper respiratory tract infections, oral thrush (oral candidiasis), headache, diarrhea, cough, tiredness (fatigue), muscle and joint pain, tonsilitis, changes in liver test results (transaminase increase), and urinary tract infection. These side effects occur in 2% or more patients who use this medicine.

When used for ankylosing spondylitis, the most common Bimzelx side effects are stuffy nose, sneezing, and sore throat, which are symptoms of throat upper respiratory tract infections, oral thrush (candidiasis), headache, diarrhea, injection site pain, rash, and vulvovaginal fungal infection. These side effects occur in 2% or more of patients who use this medicine.

Serious Bimzelx side effects

Serious side effects of Bimzelx include elevated liver enzyme levels and inflammatory bowel disease.

Elevated liver enzyme levels. Bimzelx can increase your liver enzyme levels. Before you start taking this medicine and during treatment, you will have blood blood tests to check your liver enzyme levels. If your liver enzymes increase, you may need to pause or permanently stop your treatment. Contact your healthcare provider right away if you develop any signs or symptoms of liver problems, including feeling very tired, loss of appetite, nausea, and vomiting, itchy skin, dark urine, pain on the right side of your stomach area, light-colored bowel motions, yellowing of your skin or the whites of your eyes.

Inflammatory bowel disease (IBD) Some patients develop inflammatory bowel disease or have "flare-ups" of their IBD while taking this medicine.  Tell your healthcare provider if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis) and 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 Bimzelx.

Also see the "Warnings" section below.

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.

Related/similar drugs

Warnings

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

Suicidal thoughts and behavior: This medicine may increase the risk of suicidal thoughts and behavior in some people treated with this medicine. Patients, their caregivers, and families need to watch for emerging or worsening depression, suicidal ideation, or other related mood changes. If such changes occur, promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988. Patients with a history of severe depression and/or suicidal ideation or behavior should carefully weigh the risks and benefits of treatment with this medication.

Infections. Bimzelx may increase the risk of infection. Seek medical advice if signs or symptoms of clinically important infection occur. Contact your healthcare provider If you 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.

Do not use this medicine if you have any signs of infection unless your healthcare provider instructs you to.

Tuberculosis (TB): You should not use this medicine if you have active TB; if you have latent TB, you should start treatment for latent TB before starting Bimzelx treatment.

• 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.

Liver Biochemical Abnormalities: Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Stop Bimzlex permanently in patients with causally-associated combined elevations of transaminases and bilirubin. 

Inflammatory Bowel Disease (IBD): Cases of IBD were reported in clinical trials with IL-17 inhibitors, including Bimzlex. Avoid using this medicine in patients with active IBD. Monitor for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

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 Bimzelx, 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 Bimzelx. Tell all your healthcare providers you are being treated with Bimzelx before receiving a vaccine.

Pregnancy

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

If you become pregnant while using this medicine, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. 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 this medicine 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 Bimzelx?

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

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

Ff 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.

Bimzelx administration Instructions

• Bimzelx is a subcutaneous injection (given under the skin) that can be injected into the thigh, abdomen, or back of the upper arm.
• Bimzelx 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, Bimzelx 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

Bimzelx dose for plaque psoriasis: 320 mg given at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. Adult dose.

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

Bimzelx dose for psoriatic arthritis is 160 mg by subcutaneous injection every 4 weeks.  For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis. Adult dose.

Bimzelx dose for non-radiographic axial spondyloarthritis is 160 mg by subcutaneous injection every 4 weeks. Adult dose.

Bimzelx dose for ankylosing spondylitis is 160 mg by subcutaneous injection every 4 weeks. Adult dose.

Bimzelx dose for hidradenitis suppurativa is 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter (adult dose).

Bimzelx 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.

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.

Bimzelx Prescribing Information

Review the Bimzelx Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

• Store in the refrigerator between 36°F to 46°F (2°C to 8oC).
• Injections 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

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

Bimzelx Company

Bimzelx manufacturer UCB, Inc., 1950 Lake Park Drive Smyrna, GA 30080.

Bimzelx 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 Bimzelx.

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Further information

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

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