Brand Name

Bimzelx

Generic Name
Bimekizumab
View Brand Information
FDA approval date: October 17, 2023
Form: Injection

What is Bimzelx (Bimekizumab)?

BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Approved To Treat

Top Global Experts

Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
Enrollment Status: Recruiting
Publish Date: October 10, 2025
Intervention Type: Drug
Study Phase: Phase 3

Summary: The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enrollment Status: Recruiting
Publish Date: October 10, 2025
Intervention Type: Drug
Study Phase: Phase 3

Summary: The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Enrollment Status: Recruiting
Publish Date: October 02, 2025
Intervention Type: Drug
Study Phase: Phase 3

Summary: The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).

View All Clinical Trials

Related Latest Advances

IL-17A complexes with therapeutic antibodies exhibit distinct size distributions, potentially contributing to clinically observed immunogenicity.
IL-17A complexes with therapeutic antibodies exhibit distinct size distributions, potentially contributing to clinically observed immunogenicity.
Journal: mAbs
Published: October 19, 2025
Generalized pustular psoriasis in Caucasian patient successfully and rapidly treated with bimekizumab.
Generalized pustular psoriasis in Caucasian patient successfully and rapidly treated with bimekizumab.
Journal: Italian journal of dermatology and venereology
Published: October 09, 2025
Predictive factors for early super response to bimekizumab in 341 patients with psoriasis-a 24-week short-term multicenter real-life experience.
Predictive factors for early super response to bimekizumab in 341 patients with psoriasis-a 24-week short-term multicenter real-life experience.
Journal: The Journal of dermatological treatment
Published: October 01, 2025
View All Latest Advances

Brand Information

Bimzelx (bimekizumab)
1CONTRAINDICATIONS
None.
2ADVERSE REACTIONS
The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling:
  • Suicidal Ideation and Behavior
  • Infections
  • Liver Biochemical Abnormalities
  • Inflammatory Bowel Disease
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
2.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of BIMZELX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections:conjunctivitis, esophageal candidiasis
3DESCRIPTION
Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa.
BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use.
Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1.
Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.
4PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
5INSTRUCTIONS 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,
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.
  • 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, "
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
  • 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.
Figure B
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
  • the back of your arm (
  • 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.
Step 7: Prepare your skin
  • Clean the injection site with an alcohol swab. Let the area dry completely.
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 (
Figure E
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 .
  • 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
  • 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
  • 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.
Figure GFigure H
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.
Step 12: Dispose of (throw away) the used BIMZELX autoinjector (see
  • Put the used BIMZELX autoinjector in an FDA-cleared sharps disposal container right away after use.
  • 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:
  • 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.
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:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: 9/2024
6INSTRUCTIONS for USE BIMZELX ®(bim zel' ex) (bimekizumab-bkzx) injection, for subcutaneous use single-dose prefilled syringe
This Instructions for Use contains information on how to inject BIMZELX.
Read this Instructions for Use before using the BIMZELX prefilled syringe 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.
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 prefilled syringe 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.
  • The BIMZELX prefilled syringe 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 prefilled syringe after injection.
  • Do notshare or reuse your BIMZELX prefilled syringe. You may give or get an infection.
  • Do notremove the needle cap until just before you give the injection.
How should I store BIMZELX prefilled syringe?
  • Store the BIMZELX prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • BIMZELX prefilled syringes may be stored at room temperature up to 77°F (25°C) in the original carton for up to 30 days. Do not place BIMZELX prefilled syringes 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 the BIMZELX prefilled syringe 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 prefilled syringe past the expiration date printed on the carton.
Keep BIMZELX prefilled syringes and all medicines out of the reach of children.
BIMZELX prefilled syringe parts (see
Figure A
Supplies Needed For each BIMZELX injection:
  • 1 BIMZELX prefilled syringe. You may need 2 BIMZELX prefilled syringes to give the prescribed dose.
Not provided in the BIMZELX prefilled syringe carton:
  • 1 alcohol swab
  • 1 clean cotton ball
  • 1 sharps disposal container. See, "
Setting up for your BIMZELX injection.
Step 1: Take the BIMZELX prefilled syringe carton out of the refrigerator. Do notuse the BIMZELX prefilled syringe(s) if the carton seal is broken. Throw it away and get a new one.
  • Keep the BIMZELX prefilled syringe in its original carton for 30 to 45 minutesto warm to room temperature. This will help to reduce discomfort when injecting.
  • Do notmicrowave the prefilled syringe, run hot water over it, or leave it in direct sunlight
  • Do notshake the prefilled syringe.
  • Do nottake the cap off the prefilled syringe 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 for your injection.
Step 4:Wash your hands well with soap and water and dry with a clean towel.
Step 5:Inspect the BIMZELX prefilled syringe (see
  • Remove the BIMZELX prefilled syringe 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 prefilled syringe, 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 in your thigh
  • the back of your arm
  • 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.
Step 7: Prepare your skin.
  • Clean the injection site with an alcohol swab. Let the area dry completely.
Injecting BIMZELX.
Step 8: Remove the BIMZELX prefilled syringe needle cap.
  • Hold the BIMZELX prefilled syringe around the finger grip with one hand. Pull the cap straight off (away from) the BIMZELX prefilled syringe with the other hand
Figure E
Step 9:Gently pinch and hold a fold of skin where you cleaned the injection site with one hand. With the other hand, insert the needle into your skin at about a 45-degree angle.
  • Push the needle all the way in to make sure that you inject your full dose. Then gently let go of your skin. Make sure the needle is in place
Figure F
Step 10:Firmly push the plunger head all the way down until all the medicine is injected. (see .
Figure G
  • All the medicine is injected when you cannot push the plunger head any further
Figure H
Step 11:Lift your thumb off the plunger head (see The needle will automatically move back in and lock in place.
Figure I
  • Press a clean cotton ball or gauze pad over the injection site for a few seconds. Do not rub 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 prefilled syringe (see
Figure J
  • Put the used BIMZELX prefilled syringe in an FDA-cleared sharps disposal container right away after use.
  • 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 prefilled syringe if you need to use 2 prefilled syringes to give the prescribed dose.
  • Make sure to select a new injection site on the body each time you use BIMZELX.
You can sign up to receive sharps containers for BIMZELX syringe disposal at no additional cost by going to www.BIMZELX.com or call 1-844-599-2273.
Manufactured by:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: 9/2024
7INSTRUCTIONS for USE BIMZELX ®(bim zel' ex) (bimekizumab-bkzx) injection, for subcutaneous use mg/2 mL 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.
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,
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.
  • 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
Not provided in the BIMZELX autoinjector carton:
  • 1 alcohol swab
  • 1 clean cotton ball
  • 1 sharps disposal container. See, "
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
  • 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.
Figure B
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
  • the back of your arm (
  • 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).
  • You should change (rotate) your injection site with each injection.
Step 7: Prepare your skin
  • Clean the injection site with an alcohol swab. Let the area dry completely.
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 (
Figure E
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
Important: When you remove the autoinjector, if the 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.
Step 12: Dispose of (throw away) the used BIMZELX autoinjector (see
  • Put the used BIMZELX autoinjector in an FDA-cleared sharps disposal container right away after use.
  • 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:
  • Do notrecycle your used sharps disposal container.
Figures J
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:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 10/2024
8INSTRUCTIONS for USE BIMZELX ®(bim zel' ex) (bimekizumab-bkzx) injection, for subcutaneous use mg/ 2 mL single-dose prefilled syringe
This Instructions for Use contains information on how to inject BIMZELX.
Read this Instructions for Use before using the BIMZELX prefilled syringe 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.
Each BIMZELX prefilled syringe 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 prefilled syringe 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 prefilled syringe 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 prefilled syringe after injection.
  • Do notshare or reuse your BIMZELX prefilled syringe. You may give or get an infection.
  • Do notremove the needle cap until just before you give the injection.
How should I store BIMZELX prefilled syringe?
  • Store the BIMZELX prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • BIMZELX prefilled syringes may be stored at room temperature up to 77°F (25°C) in the original carton for up to 30 days. Do not place BIMZELX prefilled syringes 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 the BIMZELX prefilled syringe 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 prefilled syringe past the expiration date printed on the carton.
Keep BIMZELX prefilled syringes and all medicines out of the reach of children.
BIMZELX prefilled syringe parts (see
Figure A
Supplies Needed For each BIMZELX injection:
  • 1 BIMZELX prefilled syringe
Not provided in the BIMZELX prefilled syringe carton:
  • 1 alcohol swab
  • 1 clean cotton ball
  • 1 sharps disposal container. See, "
Setting up for your BIMZELX injection.
Step 1: Take the BIMZELX prefilled syringe carton out of the refrigerator. Do notuse the BIMZELX prefilled syringe(s) if the carton seal is broken. Throw it away and get a new one.
  • Keep the BIMZELX prefilled syringe in its original carton for 30 to 45 minutesto warm to room temperature. This will help to reduce discomfort when injecting.
  • Do notmicrowave the prefilled syringe, run hot water over it, or leave it in direct sunlight
  • Do notshake the prefilled syringe.
  • Do nottake the cap off the prefilled syringe 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 for your injection.
Step 4:Wash your hands well with soap and water and dry with a clean towel.
Step 5:Inspect the BIMZELX prefilled syringe (see
  • Remove the BIMZELX prefilled syringe 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 prefilled syringe, 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
Figure B
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 in your thigh
  • the back of your arm
Figure CFigure D
  • 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).
  • You should change (rotate) your injection site with each injection.
Step 7: Prepare your skin.
  • Clean the injection site with an alcohol swab. Let the area dry completely.
Injecting BIMZELX.
Step 8: Remove the BIMZELX prefilled syringe needle cap.
  • Hold the BIMZELX prefilled syringe around the finger grip with one hand. Pull the cap straight off (away from) the BIMZELX prefilled syringe with the other hand
Figure E
Step 9:Gently pinch and hold a fold of skin where you cleaned the injection site with one hand. With the other hand, insert the needle into your skin at about a 45-degree angle.
  • Push the needle all the way in to make sure that you inject your full dose. Then gently let go of your skin. Make sure the needle is in place
Figure F
Step 10:Firmly push the plunger head all the way down until all the medicine is injected. (see .
Figure G
  • All the medicine is injected when you cannot push the plunger head any further
Figure H
Step 11:Lift your thumb off the plunger head (see The needle will automatically move back in and lock in place.
Figure I
  • Press a clean cotton ball or gauze pad over the injection site for a few seconds. Do not rub 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 prefilled syringe (see
Figure J
  • Put the used BIMZELX prefilled syringe in an FDA-cleared sharps disposal container right away after use.
  • 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.
You can sign up to receive sharps containers for BIMZELX syringe disposal at no additional cost by going to www.BIMZELX.com or call 1-844-599-2273.
Manufactured by:
US License No. 1736
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
9PRINCIPAL DISPLAY PANEL - 160 mg/mL Autoinjector Carton
NDC 50474-781-85
ATTENTION: Dispense enclosed
Bimzelx
160 mg/mL per autoinjector
Two single-dose autoinjectors.
For a 320 mg dose, two 160 mg
PRINCIPAL DISPLAY PANEL - 160 mg/mL Autoinjector Carton
10PRINCIPAL DISPLAY PANEL - 160 mg/mL Syringe Carton
NDC 50474-780-79
ATTENTION: Dispense enclosed
Bimzelx
160 mg/mL per syringe
Two single-dose prefilled
For a 320 mg dose, two 160 mg
PRINCIPAL DISPLAY PANEL - 160 mg/mL Syringe Carton
11PRINCIPAL DISPLAY PANEL - 320 mg/2 mL autoinjector Carton
NDC 50474-782-84
ATTENTION: Dispense enclosed
Bimzelx
320 mg/2 mL autoinjector
FOR SUBCUTANEOUS USE ONLY
One single-dose autoinjector.
PRINCIPAL DISPLAY PANEL - 320 mg/2 mL autoinjector Carton
12PRINCIPAL DISPLAY PANEL - 320 mg/2 mL Syringe Carton
NDC 50474-783-78
ATTENTION: Dispense enclosed
Bimzelx
320 mg/2 mL (160 mg/mL)
FOR SUBCUTANEOUS USE ONLY
One single-dose prefilled syringe.
PRINCIPAL DISPLAY PANEL - 320 mg/2 mL Syringe Carton