Pronunciation:

bye-me-KIZ-ue-mab - bkzx

Brand Names:

• Bimzelx

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Bimekizumab

Uses of This Medicine:

Bimekizumab-bkzx injection is used to treat moderate to severe plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is given to patients who may receive other types of treatment, including pills, injections, or phototherapy (light treatment).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bimekizumab-bkzx injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bimekizumab-bkzx injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Infection, history of or
• Inflammatory bowel disease (eg, Crohn disease or ulcerative colitis), active or
• Liver disease or
• Suicidal thoughts or behavior, history of—Use with caution. May make these conditions worse.

• Infection, active—Use is not recommended in patients with this condition.

• Tuberculosis, inactive—Should be treated first before receiving this medicine.

Proper Use of This Medicine:

This medicine is given as a shot under the skin of your thigh, stomach, or upper arm. It may be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

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 (eg, 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.

To use the 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.

To use the 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 a 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage forms (prefilled syringe or autoinjector):
  • For plaque psoriasis:
    • Adults—320 milligrams (mg) injected under the skin given as two shots (160 mg each) at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

If you miss a dose, inject it as soon as possible. Then inject the next dose at your next scheduled time.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store 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.

Throw away used autoinjector and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that the doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infection may be reduced while you are being treated with bimekizumab-bkzx. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Inflammatory bowel disease may occur while you are using this medicine. Tell your doctor right away if you have rectal bleeding, severe stomach pain, or severe diarrhea while using this medicine.

While you are being treated with bimekizumab-bkzx, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Bimekizumab-bkzx may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chest tightness

chills

cough

dryness or soreness of the throat

ear congestion

fever

headache

hoarseness

loss of voice

muscle aches

pain or tenderness around eyes and cheekbones

sneezing

sore mouth or tongue

stuffy or runny nose

tender, swollen glands in the neck

trouble breathing

trouble in swallowing

unusual tiredness or weakness

white patches in the mouth or on the tongue

Less common

Burning or stinging of the skin

diarrhea

itching in the genital or other skin areas

itching of the vagina or genitals

loss of appetite

nausea

painful cold sores or blisters on the lips, nose, eyes, or genitals

scaling

stomach pain

thick, white vaginal discharge with mild or no odor

Incidence not known

Changes in behavior

dark urine

rectal bleeding

thoughts of killing oneself

vomiting

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blemishes on the skin

burning, itching, and pain in hairy areas, pus at the root of hair

pimples

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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