Bimekizumab-bkzx (bye-me-KIZ-ue-mab - bkzx)

Treats plaque psoriasis.

Brand Name(s):

Bimzelx Autoinjector, Bimzelx PFS

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in your thighs, stomach, or upper arm.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes in 2 forms: an autoinjector and a prefilled syringe. Your doctor will tell you which dosage form you should use.
• Allow 30 to 45 minutes for the autoinjector or prefilled syringe to warm up to room temperature. Do not warm using heat sources (including hot water, microwave, or sunlight).
• Check the liquid in the autoinjector or prefilled syringe. It should be clear to slightly pearly, and colorless to pale brownish-yellow. Do not use the medicine if is cloudy, discolored, or has particles in it. Do not use the autoinjector or prefilled syringe if it looks damaged or has been dropped. Do not shake.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are bruised, red, hard, tender, thick, or scaly, or areas with psoriasis.
• Autoinjector:
  • Wash your hands with soap and water before and after using this medicine.
  • Remove the autoinjector cap. Hold the autoinjector with one hand around the handle. Pull the cap straight off with the other hand.
  • Do not touch the needle guard or recap.
  • Hold the autoinjector at a 90 degree angle. Place the autoinjector flat against your skin, then firmly press down against your skin. You will hear a "click" sound. Your injection begins when the first click is heard. Do not lift the autoinjector away from the skin.
  • Keep holding the autoinjector in place while pressing firmly against your skin. It will take about 15 seconds to receive your full dose. You will hear a second click in about 15 seconds after the first click.
  • The second click tells you that all the medicine has been injected. You should see the yellow color indicator filling the view window. If the window has not turned yellow, this means you may not have received the full dose.
  • Remove the autoinjector by pulling it straight up from your skin. Do not touch the needle.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Remove the needle cap. Hold the syringe around the finger grip with one hand and pull the needle cap straight off with your other hand. Do not touch and recap the needle.
  • Gently pinch and hold a fold of skin. With the other hand, insert the needle into your skin at about 45 degree angle.
  • Push the plunger head all the way down until all the medicine is injected.
  • Lift your thumb off the plunger head. The needle will move back and lock in place.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, inject it as soon as possible. Then inject the next dose at your next scheduled time.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store this medicine at room temperature for up to 30 days. Do not put it back in the refrigerator. Throw away any unused medicine after 30 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how bimekizumab-bkzx works. Tell your doctor if you are using cyclosporine or blood thinner (including warfarin).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, of if you have liver disease, inflammatory bowel disease (including Crohn disease or ulcerative colitis), or a history of depression, suicidal thoughts or behavior, or tuberculosis, Tell your doctor if you have any type of infection or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Changes in behavior or mood, including thoughts of suicide
  • Increased risk of infections
  • Liver problems
  • Inflammatory bowel disease
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Pain, itching, sores, or blisters on the lips, nose, eyes, or genitals
• Severe stomach pain, diarrhea
• Sores or white patches on your lips, mouth, or throat
• Unusual moods or behaviors, depression, thoughts of hurting yourself or others

If you notice these less serious side effects, talk with your doctor:

• Blemishes on the skin, pimples
• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088