Bimekizumab Injection

What is this medication?

BIMEKIZUMAB (BYE me KIZ ue mab) treats psoriasis. It works by slowing down an overactive immune system. It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Bimzelx

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• History of depression
• Immune system problems
• Infection, such as tuberculosis (TB) or other bacterial, fungal, or viral infections
• Inflammatory bowel disease, such as Crohn disease or ulcerative colitis
• Liver disease
• Recent or upcoming vaccine
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to bimekizumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It is usually given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

If you give yourself the medication at home: If you miss a dose, take it as soon as you can. Then continue your normal schedule. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines

This medication may affect how other medications work. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medication. If your care team prescribes any medication for TB, you should start taking the TB medication before starting this medication. Make sure to finish the full course of TB medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team about your vaccination history. To lower your risk of infection, you may need certain vaccines before you start this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Severe or prolonged diarrhea
• Severe stomach pain
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Cold sores
• Fatigue
• Headache
• Pain, redness, or irritation at injection site
• Small, red, pus-filled bumps on skin around hair follicles
• Thrush—white patches in the mouth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to use it. Protect from light.

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Get rid of any unused medication after the expiration date.

Room temperature: If needed, this medication may be stored at room temperature for up to 30 days. Once it has been stored at room temperature, do not place it back in the refrigerator. Write the date removed from the refrigerator on the carton and get rid of any unused mediation after 30 days or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.