Bimzelx (bimekizumab-bkzx) is used to treat moderate to severe plaque psoriasis in adults who may benefit from using systemic therapy or phototherapy (light therapy). Bimzelx is the first FDA psoriasis treatment that works by selectively inhibiting IL-17A and IL-17F, which are two proteins that are involved with the psoriasis inflammatory process. Bimzelx may be self injected by the patient as subcutaneous injection under the skin every 4 weeks initially then every 8 weeks.

Bimzelx became an FDA-approved medicine on October 18, 2023, approval was based on positive results from three Phase 3 randomized clinical trials (BE READY, BE VIVID and BE SURE). In these clinical trials Bimzelx was compared to active comparator medicines adalimumab, ustekinumab and secukinumab, it was also compared to placebo treatment. Bimzelx consistently and effectively improved plaque psoriasis with lasting levels of skin clearance.

What is plaque psoriasis?

Plaque psoriasis in a long lasting (chronic) inflammatory skin condition that results from by an over active immune system (autoimmune disease), along with genetic and environmental factors. Immune factors and messenger protein (inflammatory cytokines) including IL-17 increase inflammation and are involved in driving the psoriasis inflammatory processes.

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

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

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. Bimzelx 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 Bimzelx, 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 Bimzelx, 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.

Read the detailed "Instructions for Use" that comes with your Bimzelx 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 Bimzelx exactly as prescribed by your healthcare provider.

Before injecting, remove the carton from the refrigerator and allow Bimzelx 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 cloudy.

Bimzelx administration Instructions

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

Usual adults Bimzelx dose: 320 mg (given as 2 subcutaneous injections of 160 mg each) 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.

Bimzelx is available as:

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

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

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.