Bimzelx

Bimzelx (bimekizumab) is a prescription biologic medicine used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nraxSpA), and hidradenitis suppurativa (HS), in certain patients.

Bimzelx works by targeting and blocking proteins in the immune system, IL-17A and IL-17F, to reduce inflammation and improve symptoms in these immune-mediated inflammatory diseases.

Bimzelx is given as a subcutaneous injection (under the skin) usually every 2 to 4 weeks initially, which may be extended to every 8 weeks in some patients, depending on the condition treated. Bimzelx may be self-injected by the patient using an auto-injector or a prefilled syringe.

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
• active ankylosing spondylitis (AS) in adults
• moderate to severe hidradenitis suppurativa (HS) in adults.

Bimzelx works by blocking two inflammatory proteins in the immune system called IL-17A and IL-17F (interleukin-17A and interleukin-17F). These proteins signal immune cells to promote inflammation and are overactive in these immune-mediated inflammatory diseases. When Bimzelx inhibits IL-17A and IL-17F, it reduces inflammatory signaling, which helps calm the immune response, reduce tissue inflammation, and improve symptoms such as skin lesions, joint pain, and stiffness.

Bimzelx is an IL-17A and IL-17F antagonist from a class of medicines called interleukin inhibitors.

Bimzelx FDA approval was originally granted for plaque psoriasis on October 18, 2023. FDA approval was based on positive results from three Phase 3 randomized clinical trials (BE READY - NCT03410992, BE VIVID - NCT03370133, and BE SURE - NCT03412747). At week 16, 85-91% of patients treated with Bimzelx achieved clear or almost clear skin, with 59-68% achieving complete clearance.

Bimzelx FDA approval was extended to include psoriatic arthritis, ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nraxSpA) on September 23, 2024. The most recent FDA indication approved was hidradenitis suppurativa (HS) on November 19, 2024, after positive results from two Phase 3 studies, BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498). 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.

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. This 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.

If the solution and container permit, check the injection solution for particulate matter and discoloration before administration. Do not use it 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.
• If 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.

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: In clinical trials elevated serum transaminases were reported. Liver enzymes, alkaline phosphatase, and bilirubin should be tested at baseline and according to routine patient management. Bimzelx should be stopped permanently in patients with causally-associated combined elevations of transaminases and bilirubin.

Inflammatory Bowel Disease (IBD): IBD cases were reported in clinical trials with IL-17 inhibitors, including Bimzelx. Patients with active IBD should avoid using this medicine. Monitor for signs and symptoms of IBD during treatment and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations: Live vaccines should be avoided in patients being treated with this medicine. All age-appropriate vaccinations as recommended by current immunization guidelines should be completed before starting this medicine.

See "Bimzelx side effects" for more information about side effects.

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.

Common Bimzelx side effects

Most common Bimzelx side effects when used for psoriasis and hidradenitis suppurativa are upper respiratory tract infections, fungal infections (oral thrush or infections in the mouth, throat, skin, nails, feet or genitals), headache, injection site reactions, stomach flu (gastroenteritis), herpes simplex injections (cold sores in or around the mouth) infections, acne, inflammation or infection of the hair follicles (folliculitis), and tiredness (fatigue). These side effects occurred in 1% or more patients.

Side effects for Bimzelx when used for psoriatic arthritis are upper respiratory tract infections, oral thrush or infections in the mouth, headache, diarrhea, and urinary tract infection (UTI). These side effects occurred in 2% or more patients.

Side effects for Bimzelx when used for non-radiographic axial spondyloarthritis (incidence 2% or more) were upper respiratory tract infections, oral thrush or infections in the mouth, headache, diarrhea, cough, tiredness, musculoskeletal pain, muscle pain, tonsillitis, transaminase increase (liver enzyme increase), and urinary tract infection.

Common side effects for Bimzelx when used for ankylosing spondylitis (incidence 2% or more) are upper respiratory tract infections, oral thrush or infections in the mouth, headache, diarrhea, injection site pain, rash and vaginal yeast infections.

Serious 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 the FDA at 1-800-FDA-1088.

Bimzelx dosing varies by condition. Below are the recommended adult dosing regimens by indication, based on prescribing information.

Bimzelx dose for plaque psoriasis (adults)

• 320 mg given at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
• 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 (adults)

• 160 mg by subcutaneous injection every 4 weeks.
• For patients with psoriatic arthritis and also moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis.

Bimzelx dose for non-radiographic axial spondyloarthritis (adults)

• 160 mg by subcutaneous injection every 4 weeks.

Bimzelx dose for ankylosing spondylitis (adults)

• 160 mg by subcutaneous injection every 4 weeks.

Bimzelx dose for hidradenitis suppurativa (adults)

• 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 in the following injection options:

• 160 mg/mL prefilled syringe
• 160 mg/mL autoinjector
• 320 mg/2 mL prefilled syringe
• 320 mg/2 mL autoinjector

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 may interact with other medicines you take. This includes prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Not all possible drug interactions are known, so it’s important to tell your healthcare provider about everything you take.

Medicines Affected by Inflammation Changes

Some medicines are processed by the liver using enzymes called CYP450 enzymes. In people with chronic inflammatory diseases, inflammation can change how these enzymes work. Because Bimzelx reduces inflammation, it may also change how your body processes certain medicines.

If you take medications that require very precise dosing, your healthcare provider may want to:

• Monitor how well the medicine is working, or
• Check drug levels in your blood, and
• Adjust the dose if needed

Examples include medicines such as warfarin (a blood thinner) or cyclosporine (an immune-suppressing drug).

Using Bimzelx with Other Arthritis Medicines

Studies show that taking Bimzelx with common arthritis medications (such as methotrexate) or having used other biologic treatments in the past does not affect how Bimzelx works in the body.

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.

• 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.

Active ingredient: bimekizumab-bkzx

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

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