Bimzelx

Generic name: Bimekizumab
Dosage form: single-dose prefilled syringe (160 mg/mL), single-dose prefilled autoinjector (160 mg/mL)

Usage of Bimzelx

Bimzelx (bimekizumab) is an interleukin inhibitor used to treat types of plaque psoriasis in adults. Bimzelx reduces inflammation and improves plaque psoriasis symptoms by inhibiting two proteins (IL-17A and IL-17F) involved with the psoriasis inflammatory process. Bimzelx may be self-injected by the patient as a 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 consistently and effectively improved plaque psoriasis with lasting levels of skin clearance.

Bimzelx is used to treat moderate to severe plaque psoriasis in adults who may benefit from systemic or light therapy phototherapy.

Bimzelx side effects

Common side effects

The most common side effects of Bimzelx 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 Bimzelx side effects

Also see "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 Bimzelx.

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.

Before taking Bimzelx

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 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 your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use Bimzelx

Usual adult 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, your 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.

Warnings

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

Suicidal thoughts and behavior has 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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.