Uses

This medication is used to treat a certain skin condition (plaque psoriasis). Bimekizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking certain natural proteins in your body (interleukin-17A and interleukin-17F) that cause inflammation and swelling. Bimekizumab can help lessen symptoms caused by this condition, such as pain, itching, and scaling of the skin.

How To Use

Read the Medication Guide and, if available, the Patient Information Leaflet and Instructions for Use leaflet provided by your pharmacist before you start using bimekizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting treatment with this medication, your doctor will test you for tuberculosis (TB). Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.

This medication is given by injection under your skin as directed by your doctor, usually every 4 weeks for the first 16 weeks, then every 8 weeks. Each dose requires 2 injections, one after the other. The injections are given in the upper arms, thighs, or abdomen (at least 2 inches from your belly button). The dosage and treatment schedule are based on your medical condition, weight, and response to treatment. Follow your doctor's instructions carefully.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product instructions. Wash your hands before using this medication. Remove the medication from the refrigerator 30 to 45 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way such as by heating in the microwave, placing in hot water, or leaving it in direct sunlight. Do not shake the medication. Before using, check this product visually for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, bruised, red, scaly, or hard, or areas with scars or stretch marks. Learn how to store and discard medical supplies safely. Do not share or reuse syringes or the injection device. You may give or get an infection.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to use the medication.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Pain, redness, or swelling at the injection site may occur. Cold symptoms (such as runny/stuffy nose) may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, white patches in the mouth, fever, chills, cough).

Tell your doctor right away if you have any serious side effects, including:

• stomach/abdominal pain
• diarrhea with blood/mucus
• mental/mood changes (such as depression, anxiety, thoughts of suicide)
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using bimekizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent/returning infection (such as tuberculosis, herpes)
• bowel disease (such as Crohn's disease, ulcerative colitis)
• mental/mood problems (such as depression, suicidal thoughts)
• liver disease

Bimekizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using bimekizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function tests, skin exams) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. Use your next dose on your regular schedule (for example, 4 or 8 weeks later). Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the refrigerator. Do not freeze. If this product is taken out of the refrigerator and stored at room temperature, ask your pharmacist or read the product package to see how long your medication can be stored at room temperature. Do not put room-temperature product back in the refrigerator. Keep the product in the original carton to protect from light. Discard any unused portion after use.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.