Bimekizumab-bkzx injection

WHY is this medicine prescribed?

Bimekizumab-bkzx injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in certain adults. It is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Bimekizumab-bkzx injection is also used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain and joint damage) in adults. It is also used to treat active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas causing pain and signs of swelling, but without changes seen on x-ray) in adults. Bimekizumab-bkzx is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of psoriasis.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Bimekizumab-bkzx comes as a solution (liquid) in a prefilled syringe and as a prefilled autoinjector to inject subcutaneously (under the skin). To treat plaque psoriasis, it is usually injected once every 4 weeks for the first 5 doses and then once every 8 weeks after that. To treat psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis, it is usually injected once every 4 weeks. If you are injecting bimekizumab-bkzx injection yourself, follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use bimekizumab-bkzx injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You may receive your first dose of bimekizumab-bkzx injection in your doctor's office. If you are an adult, your doctor may allow you or a caregiver to perform the bimekizumab-bkzx injections at home after you have been trained. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject and prepare it.

Use each syringe or autoinjector only once and inject all the solution in the syringe or autoinjector. Dispose of used syringes and autoinjector in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Remove the prefilled syringe or autoinjector from the refrigerator. Place it on a flat surface without removing the needle cap and allow it warm to room temperature for 30-45 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, leaving it in sunlight, or through any other method.

Do not shake a syringe or autoinjector that contains bimekizumab-bkzx.

Always look at bimekizumab-bkzx solution before injecting it. Check that the expiration date has not passed and that the liquid is clear or slightly yellow. The liquid should not contain visible particles. Do not use a syringe or autoinjector if it is cracked or broken, if it is expired or frozen, or if the liquid is cloudy or contains small particles.

You can inject bimekizumab-bkzx injection anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If you have a caregiver to inject the medication, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks. Do not inject bimekizumab-bkzx into an area affected by psoriasis. If your doctor has told you to inject two syringes of bimekizumab-bkzx for each dose, choose a different spot for each injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide and Instructions for Use) when you begin treatment with bimekizumab-bkzx injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm ) to obtain the Medication Guide, or the manufacturer's website to obtain the Medication Guide and the Instructions for Use.

Bimekizumab-bkzx may help to control your symptoms, but will not cure your condition. Continue to use bimekizumab-bkzx even if you feel well. Do not stop using bimekizumab-bkzx without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before using bimekizumab-bkzx,

• tell your doctor and pharmacist if you are allergic to bimekizumab-bkzx, medications, or any of the ingredients in bimekizumab-bkzx injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking bimekizumab-bkzx. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had depression or attempt or thoughts of harming yourself, liver problems, or inflammatory bowel disease (IBD; a group of conditions that cause swelling of the lining of the intestines) such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using bimekizumab-bkzx, call your doctor.

• tell your doctor if you have recently received a vaccine. Also check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor. It is important that adults receive all age-appropriate vaccines before beginning treatment with infliximab.

• you should know that bimekizumab-bkzx injection has caused suicidal thoughts and behaviors (thoughts or attempts to harm yourself). Call your doctor right away if you have 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, or attempt to commit suicide.

• you should know that bimekizumab-bkzx injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with bimekizumab-bkzx injection, call your doctor immediately: fever, sweats, or chills, muscle aches, shortness of breath, warm, red, or painful skin or sores on your body, diarrhea, stomach pain, frequent, urgent, or painful urination, or other signs of infection. Your doctor will probably delay your treatment with bimekizumab-bkzx injection if you have an infection.

• you should know that using bimekizumab-bkzx injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using bimekizumab-bkzx injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it and then resume normal dosing schedule.

What SIDE EFFECTS can this medicine cause?

Bimekizumab-bkzx injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• cold sores (sores around the mouth or lips)
• small, red bumps on your skin
• feeling tired
• yeast or fungal infection of the mouth or throat (patches or white in or around the mouth, difficulty or painful swallowing), skin, nails, feet (scaly, itchy skin or thickening of nails), or genitals (white discharge, itching)
• pain, redness or swelling at the injection site
• stuffy or runny nose, sneezing, or sore throat
• stomach pain
• diarrhea
• acne

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• right-sided lower stomach pain, feeling tired, loss of appetite, nausea and vomiting, itching, dark urine, light-colored stool, yellowing of the skin or eyes

Bimekizumab-bkzx may cause flare-ups of inflammatory bowel disease (ulcerative colitis, crohn's disease). If you have worsening disease symptoms or new onset stomach pain or diarrhea, talk to your doctor. Your doctor may stop treatment.

Bimekizumab-bkzx may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in to protect it from light, tightly closed, and out of reach of children. Store bimekizumab-bkzx injection in the refrigerator, but do not freeze it. If needed, you may store bimekizumab-bkzx injection at room temperature for up to 30 days in the original carton to protect it from light. Once stored at room temperature, do not return bimekizumab-bkzx injection to the refrigerator. Discard bimekizumab-bkzx injection if it is not used within 30 days at room temperature.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to bimekizumab-bkzx.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.