Patient information: uses, side effects, how to take - Bimzelx

What is the most important information I should know about BIMZELX?

BIMZELX is a medicine that affects your immune system. BIMZELX may increase your risk of having serious side effects, including:

Suicidal thoughts and behavior. New or worsening suicidal thoughts and behavior have happened in some people treated with BIMZELX.Get medical help right away or call the National Suicide and Crisis Lifeline at 988 if you, your caregiver or your family member notice in you 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
- attempt to commit suicide
Infections. BIMZELX is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections, including serious infections.
- Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with BIMZELX.
- If your healthcare provider feels you are at risk for TB, you may be treated with medicine for TB before you begin treatment with BIMZELX and during your treatment with BIMZELX.
- Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with BIMZELX. Do not take BIMZELX if you have an active TB infection.

Before starting BIMZELX, tell your healthcare provider if you:

are being treated for an infection
have an infection that does not go away or keeps coming back
have TB or have been in close contact with someone with TB
think you have an infection or have symptoms of an infection such as:

fever, sweats, or chills
muscle aches
cough
shortness of breath
blood in your phlegm

weight loss
warm, red, or painful skin or sores on your body different from your psoriasis
diarrhea or stomach pain
burning when you urinate or urinating more often than normal

After starting BIMZELX, call your healthcare provider right away if you have any of the signs of infection listed above.Do not use BIMZELX if you have any signs of infection unless you are instructed to by your healthcare provider.

See " What are the possible side effects of BIMZELX ?" for more information about side effects.

What is BIMZELX?

BIMZELX is a prescription medicine used to treat:

adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet light alone or with pills (phototherapy).
adults with active psoriatic arthritis.
adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
adults with active ankylosing spondylitis.
adults with moderate to severe hidradenitis suppurativa.

It is not known if BIMZELX is safe and effective in children.

Before using BIMZELX, tell your healthcare provider about all of your medical conditions, including if you:

have any of the conditions or symptoms listed in the section "What is the most important information I should know about BIMZELX?"
have a history of depression, or suicidal thoughts or behavior
have liver problems
have inflammatory bowel disease (Crohn's disease or ulcerative colitis)
have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with BIMZELX. Tell all your healthcare providers that you are being treated with BIMZELX before receiving a vaccine.
are pregnant or plan to become pregnant. It is not known if BIMZELX can harm your unborn baby.
- If you become pregnant while taking BIMZELX, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-311-8972 to enroll in this registry or visit http://mothertobaby.org/pregnancy-studies/.
are breastfeeding or plan to breastfeed. It is not known if BIMZELX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with BIMZELX.

Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins and herbal supplements.

How should I use BIMZELX?

See the detailed " Instructions for Use" that comes with your BIMZELX for information on how to prepare and inject a dose of BIMZELX, and how to properly throw away (dispose of) used BIMZELX autoinjectors and prefilled syringes.

Use BIMZELX exactly as prescribed by your healthcare provider.
If you miss your BIMZELX dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.

What are the possible side effects of BIMZELX?

BIMZELX may cause serious side effects, including:

See " What is important information I should know about BIMZELX?"
Elevated liver enzyme levels.Your healthcare provider will do blood tests to check your liver enzyme levels before starting treatment and during treatment with BIMZELX. Your healthcare provider may temporarily stop or permanently stop your treatment with BIMZELX if you develop liver problems. Call your healthcare provider right away if you develop any signs or symptoms of liver problems, including:

pain on the right side of your stomach-area
feeling very tired
loss of appetite
nausea and vomiting

itching
dark urine
light-colored stool
yellowing of your skin or the whites of your eyes

Inflammatory bowel disease.New cases of inflammatory bowel disease or "flare-ups" have happened with BIMZELX. If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis), tell your healthcare provider if you have worsening disease symptoms during treatment with BIMZELX or develop new symptoms of stomach pain or diarrhea. Your healthcare provider will stop treatment with BIMZELX if you develop new or worsening signs of Crohn's disease or ulcerative colitis.

The most common side effects of BIMZELX in people treated for Psoriasis and Hidradenitis Suppurativa include:

upper respiratory tract infections
headache
herpes simplex infections (cold sores in or around the mouth)
small red bumps on your skin
feeling tired

fungal infections (oral thrush or infections in the mouth, throat, skin, nails, feet or genitals)
pain, redness or swelling at injection site
stomach flu (gastroenteritis)
acne

The most common side effects of BIMZELX in people treated for psoriatic arthritis include:

upper respiratory tract infections
headache
urinary tract infection

oral thrush or infections in the mouth
diarrhea

The most common side effects of BIMZELX in people treated for non-radiographic axial spondyloarthritis include:

upper respiratory tract infections
headache
cough
joint pain
tonsilitis
urinary tract infection

oral thrush or infections in the mouth
diarrhea
feeling tired
muscle aches
liver enzyme increase

The most common side effects of BIMZELX in people treated for ankylosing spondylitis include:

upper respiratory tract infections
headache
pain at injection site
vaginal yeast infections

oral thrush or infections in the mouth
diarrhea
rash

These are not all of the possible side effects of BIMZELX.

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

How should I store BIMZELX?

Store BIMZELX in the refrigerator between 36°F to 46°F (2°C to 8°C).
BIMZELX may be stored at room temperature up to 77°F (25°C) for up to 30 days in the original carton. Do notplace BIMZELX prefilled syringes or autoinjectors back in the refrigerator after they have been stored at room temperature.
Write the date removed from the refrigerator in the space provided on the carton and throw away BIMZELX if it has been kept at room temperature and not been used within 30 days.
Keep BIMZELX in the original carton until ready for use to protect from light.
Do not freeze BIMZELX.
Do not shake BIMZELX.
Do not use BIMZELX past the expiration date printed on the carton.

Keep BIMZELX and all medicines out of the reach of children.

General information about the safe and effective use of BIMZELX.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BIMZELX for a condition for which it was not prescribed. Do not give BIMZELX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BIMZELX that is written for health professionals.

What are the ingredients in BIMZELX?

Active ingredient: bimekizumab-bkzx

Inactive ingredients: glacial acetic acid, glycine, polysorbate 80, sodium acetate and Water for Injection, USP.

Manufactured by:

UCB, Inc.

1950 Lake Park Drive Smyrna, GA 30080

US License No. 1736

For more information, go to www.BIMZELX.com or call 1-844-599-2273

INSTRUCTIONS for USE

BIMZELX ^®(bim zel' ex)

(bimekizumab-bkzx)

injection, for subcutaneous use

single-dose autoinjector

This Instructions for Use contains information on how to inject BIMZELX.

Read this Instructions for Use before using the BIMZELX autoinjector and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

These instructions are for 1 injection only. You may need more than 1 injection at a time depending on your prescribed dose of BIMZELX. Each BIMZELX autoinjector is for one-time (single-dose) use only.

Important Information you Need to Know Before Injecting BIMZELX:

Your healthcare provider should show you or a caregiver how to prepare and inject BIMZELX using the autoinjector for the first time. Do not inject yourself or someone else until you have been shown how to inject BIMZELX the right way. Call your healthcare provider if you have any questions.
These instructions are for 1 injection only.
The BIMZELX autoinjector has a needle safety feature that will be activated to cover the needle after the injection is finished. The needle safety feature will help to prevent needle stick injuries to anyone who handles the autoinjector after injection.
Do notshare or reuse your BIMZELX autoinjector. You may give or get an infection.
Do notremove the needle cap until just before you give the injection.
If you have vision or hearing problems, do notuse the BIMZELX autoinjector without help from a caregiver.

How should I store BIMZELX autoinjector?

Store the BIMZELX autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
BIMZELX autoinjectors may be stored at room temperature up to 77°F (25°C) in the original carton for up to 30 days. Do notplace BIMZELX autoinjectors back in the refrigerator after they have been stored at room temperature.
Write the date removed from the refrigerator in the space provided on the carton and throw away if it has been kept at room temperature and not used within 30 days.
Keep BIMZELX in the original carton until ready for use to protect from light.
Do not freeze BIMZELX.
Do not shake BIMZELX.
Do not use the BIMZELX autoinjector past the expiration date printed on the carton.

Keep BIMZELX autoinjectors and all medicines out of the reach of children.

BIMZELX autoinjector parts (see Figure A):

Supplies Needed for each BIMZELX injection

1 BIMZELX autoinjector. You may need 2 BIMZELX autoinjectors to give the prescribed dose.

Not provided in the BIMZELX autoinjector carton:

1 alcohol swab
1 clean cotton ball
1 sharps disposal container. See, " Step 12: Dispose of (throw away) the used BIMZELX autoinjector " at the end of this Instructions for Use.

Setting up for your BIMZELX injection.

Step 1: Take the BIMZELX autoinjector carton out of the refrigerator. Do notuse the BIMZELX autoinjector(s) if the carton seal is broken. Throw it away and get a new one.

Keep the BIMZELX autoinjector in its original carton for 30 to 45 minutesto warm to room temperature. This will help to reduce discomfort when injecting.
- Do notmicrowave the autoinjector, run hot water over it, or leave it in direct sunlight.
- Do notshake the autoinjector.
- Do nottake the cap off the autoinjector until you are ready to inject.

Step 2: Find a clean, flat, and well-lit work surface, like a table.

Step 3:Gather the supplies needed for your injection.

Step 4:Wash your hands well with soap and water and dry with a clean towel.

Step 5:Inspect the BIMZELX autoinjector (see Figure B):

Remove the BIMZELX autoinjector from the carton.
Make sure the name BIMZELX appears on the label.
- Check the expiration date printed on the label.
- Check the medicine through the Viewing Window. The medicine inside should be clear to slightly pearly, and colorless to pale brownish-yellow. You may see air bubble(s) in the liquid. This is normal.
Do not use the BIMZELX autoinjector,throw it away and get a new one if:
- The expiration date printed on the label has passed.
- The medicine is cloudy, discolored, or has particles.
- It looks damaged or has been dropped.

Choose and prepare your injection site.

Step 6: Choose and clean your injection site.

The sites you may choose for your injection are:
- your stomach area (abdomen) or your thigh (see Figure C ).
- the back of your arm ( see Figure D ). BIMZELX may be injected into the back of your arm by a healthcare provider or caregiver only.

Do notinject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis , or within 2 inches of the belly button (navel).
Choose a new injection site on the body each time you use BIMZELX. Do notuse the same injection site 2 times in a row.

Step 7: Prepare your skin

Clean the injection site with an alcohol swab. Let the area dry completely. Do nottouch the cleaned area again before injecting.

Injecting BIMZELX.

Step 8: Remove the BIMZELX autoinjector cap.

Hold the BIMZELX autoinjector firmly with one hand around the handle. Pull the cap straight off (away from) the autoinjector with the other hand ( see Figure E ). Although you cannot see the needle tip, it is now uncovered.
- Putthe cap into an FDA-cleared sharps disposal container right away. You will not need it again.
- Do nottouch the needle guard or put the cap back on as it could activate the autoinjector and you can stick yourself.

Step 9:Hold the BIMZELX autoinjector at a 90-degree angle to the cleaned injection site (see Figure F).

Step 10:Place the BIMZELX autoinjector flat against your skin, then firmly press the BIMZELX autoinjector down against your skin. You will hear a "click" sound. Your injection begins when the 1 ^st"click" is heard (see Figure G) .

Do notlift the autoinjector away from the skin.

Keep holding the BIMZELX autoinjector in place and pressed firmly against your skin. It will take about 15 seconds to receive your full dose.

You will hear a 2 ^nd"click" in about 15 seconds after you hear the first click.
The second click tells you that all the medicine has been injected and your BIMZELX injection is finished. You should see the yellow color indicator filling the viewing window (see Figure H) .
Important:When you remove the autoinjector, if the viewing window has not turned yellow this means you may not have received a full dose. Call your healthcare provider right away.

Step 11:Remove the BIMZELX autoinjector by carefully pulling the BIMZELX autoinjector straight up from your skin. The needle guard will automatically cover the needle. Do nottry to touch the needle.

Press a clean cotton ball over the injection site for a few seconds. Do notrub the injection site. You may see slight bleeding or a drop of liquid. This is normal. You may cover the injection site with a small adhesive bandage, if needed.

Step 12: Dispose of (throw away) the used BIMZELX autoinjector (see Figure I).

Put the used BIMZELX autoinjector in an FDA-cleared sharps disposal container right away after use. Do notthrow away (dispose of) the BIMZELX autoinjector in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do notrecycle your used sharps disposal container.

Step 13: Repeat steps 1 through 12 with a new BIMZELX autoinjector if you need to use 2 autoinjectors to give the prescribed dose.

Make sure you select a new injection site on the body each time you use BIMZELX. Do notuse the same site that you used for your first injection.

You can sign up to receive sharps containers for BIMZELX autoinjector disposal at no additional cost by going to www.BIMZELX.comor call 1-844-599-2273.

Manufactured by:

UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080

US License No. 1736

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 9/2024