Bimzelx bimekizumab 160 mg/mL Injection, Solution, 1 syringe — NDC 50474-780-78 (Billing 50474-0780-78)
This is a package of 1 syringe of Bimzelx bimekizumab 160 mg/mL Injection, Solution from UCB, Inc., marketed since Oct 2023 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 50474-780-78 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 50474 labeler · 780 product · 78 package
- Package marketed since
- Oct 1, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5047478078 7
- Medicaid fills, this package
- 214 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 082752
- GCN: 51344
- GPI-14 (Medi-Span): 9025051800E520
- HICL (First Databank): 047629
- AHFS class code: 84:06.28.00
- RxCUI (RxNorm): 2668086
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Interleukin inhibitors class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Bimekizumab-bkzx injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in certain adults. It is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Bimekizumab-bkzx injection is also used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain and joint damage) in adults. It is also used to treat active non-radiographic axial spondyloarthritis (a condition in which the bod...
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $8,011.04 | $8,011.04 / 1 ml |
| Medicare drug plans payPart D · Q2 2026 | $8,473.99 | $8,473.99 / 1 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50474-0780-79 50474-780-79 Main listing | 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS | 2023-10-17 | — | Active |
| 50474-0780-78 You're viewing this | 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS | 2024-10-01 | — | Active |
This pack accounts for about 35% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 50474-0780-79?
What NDC number is used to bill for this package of Bimzelx bimekizumab 160 mg/mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bimzelx 160 mg/mL 50474-0781-85 | UCB, | 2 syringes | $8,112.590 | — | Availability likely | — |
| Bimzelx 160 mg/mLthis 50474-0780-78 | UCB, | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 17, 2035 |
Is there a biosimilar for BIMZELX 160 MG/ML SYRINGE?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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1.23 mg / 1 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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16.5 mg / 1 mL
UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
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0.4 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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2.83 mg / 1 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) . ( 1.2 ) Adults with active non-radiographic axial spondyloarthritis ( nr-axSpA ) with objective signs of inflammation.
( 1.3 ) Adults with active ankylosing spondylitis ( AS ). ( 1.4 ) Adults with moderate to severe hidradenitis suppurativa (HS) . ( 1.5 )
1.1Plaque Psoriasis BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
1.2Psoriatic Arthritis BIMZELX is indicated for the treatment of adults with active psoriatic arthritis.
1.3Non-Radiographic Axial Spondyloarthritis BIMZELX is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
1.4Ankylosing Spondylitis BIMZELX is indicated for the treatment of adults with active ankylosing spondylitis.
1.5Hidradenitis Suppurativa BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to treatment: ( 2.1 ) Evaluate patients for tuberculosis infection. Test liver enzymes, alkaline phosphatase, and bilirubin. Complete all age-appropriate vaccinations as recommended by current immunization guidelines.
Plaque Psoriasis Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16. ( 2.2 ) Psoriatic Arthritis Administer 160 mg by subcutaneous injection every 4 weeks.
( 2.3 ) For patients with coexisting moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis. ( 2.2 ) Non-Radiographic Axial Spondyloarthritis Administer 160 mg by subcutaneous injection every 4 weeks. ( 2.4 ) Ankylosing Spondylitis Administer 160 mg by subcutaneous injection every 4 weeks.
( 2.5 ) Hidradenitis Suppurativa Administer 320 mg by subcutaneous injection at Week 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter. ( 2.6 ) See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. ( 2.7 , 2.8 , 2.9 )
2.1Recommended Evaluations and Immunization Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.3) ] . Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with BIMZELX [see Warnings and Precautions (5.4) ] . Complete all age-appropriate vaccinations as recommended by current immunization guidelines [see Warning and Precautions (5.6) ] .
2.2Recommended Dosage for Plaque Psoriasis The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter . For patients weighing 120 kg or more, consider a dosage of 320 mg every 4 weeks after Week 16 [see Clinical Pharmacology (12.3) ] .
2.3Recommended Dosage for Psoriatic Arthritis The recommended dosage is 160 mg by subcutaneous injection every 4 weeks. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis [see Dosage and Administration (2.2) ] .
2.4Recommended Dosage for Non-Radiographic Axial Spondyloarthritis The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
2.5Recommended Dosage for Ankylosing Spondylitis The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
2.6Recommended Dosage for Hidradenitis Suppurativa The recommended dosage is 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
2.7Missed Doses If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.
2.8Preparation Instructions Before injecting, remove the carton with BIMZELX from the refrigerator and allow BIMZELX to reach room temperature (30 to 45 minutes) without removing the prefilled syringes or autoinjectors from the carton to protect from light. Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BIMZELX injection is clear to slightly opalescent, and colorless to pale brownish- yellow.
Do not use if the solution contains visible particles, is discolored or cloudy.
2.9Administration Instructions BIMZELX is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of BIMZELX according to the "Instructions for Use" [see Instructions for Use].
If two separate 160 mg injections are used to achieve the recommended dose, administer each injection subcutaneously at a different anatomic location (such as thighs, abdomen or back of upper arm). Discard the… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection : 160 mg/mL in a single-dose prefilled syringe or single-dose prefilled autoinjector. ( 3 ) Injection : 320 mg/2 mL (160 mg/mL) in a single-dose prefilled syringe or single-dose prefilled autoinjector. ( 3 ) Injection (1 mL): 160 mg/mL clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
Injection (2 mL): 320 mg/2 mL (160 mg/mL) clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Suicidal Ideation and Behavior (SI/B) : May increase risk of SI/B. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct patients to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988.
Carefully weigh risks and benefits of treatment with BIMZELX in patients with a history of severe depression and/or suicidal ideation or behavior. ( 5.1 ) Infections : May increase risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur.
If such an infection develops, do not administer BIMZELX until the infection resolves. ( 5.2 ) Tuberculosis (TB) : Avoid use in patients with active TB. Initiate treatment of latent TB prior to BIMZELX treatment.
( 5.3 ) Liver Biochemical Abnormalities : Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and according to routine patient management. Permanently discontinue use of BIMZELX in patients with causally - associated combined elevations of transaminases and bilirubin.
( 5.4 ) Inflammatory Bowel Disease (IBD) : Cases of IBD were reported in clinical trials with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
( 5.5 ) Immunizations : Avoid the use of live vaccines in patients treated with BIMZELX. ( 5.6 )
5.1Suicidal Ideation and Behavior An increased incidence of new onset or worsening suicidal ideation and behavior was observed in subjects treated with BIMZELX. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been definitively established. Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials.
The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from "none" to "active suicidal ideation with specific plan and intent") and behaviors (rating the injury and potential lethality of self-injury, if present). Plaque Psoriasis During the two 16-week, placebo-controlled periods of Trials Ps-1 and Ps-2, higher rates of suicidal ideation as assessed by C-SSRS were reported in BIMZELX-treated subjects than in subjects receiving placebo. Pooled analysis of C-SSRS data indicated that 12/670 (1.8%) BIMZELX-treated subjects and 1/169 (0.6%) subjects receiving placebo reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39, 22.74).
Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new onset suicidal ideation on the C-SSRS than subjects receiving placebo (1.3% vs 0.6%). During the open-label extension trial, one completed suicide was reported in a BIMZELX-treated subject [see Adverse Reactions (6.1) ]. Psoriatic Arthritis Pooled analysis of C-SSRS data from the two 16-week, placebo-controlled periods of Trials PsA-1 and PsA-2 indicated that 2/698 (0.3%) BIMZELX-treated subjects and 3/413 (0.7%) subjects receiving placebo reported passive suicidal ideation with an estimated relative risk of 0.35 (95% confidence interval: 0.05, 2.29) [see Adverse Reactions (6.1) ] .
Non-Radiographic Axial Spondyloarthritis Analysis of C-SSRS data from a 16-week, placebo-controlled period of Trial nr-axSpA-1 indicated that no subjects, being treated either with BIMZELX or placebo, reported suicidal ideation [see Adverse Reactions (6.1) ] . Ankylosing Spondylitis Analysis of C-SSRS data from a 16-week, placebo-controlled period of Trial AS-1 indicated that no subjects, being treated either with BIMZELX or placebo, reported suicidal ideation [see Adver… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE 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 [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Liver Biochemical Abnormalities [see Warnings and Precautions (5.4) ] Inflammatory Bowel Disease [see Warnings and Precautions (5.5) ] Most common adverse reactions are: Psoriasis and Hidradenitis Suppurativa (incidence ≥ 1%): upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.
( 6.1 ) Psoriatic Arthritis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection. ( 6.1 ) Non-Radiographic Axial Spondyloarthritis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase, and urinary tract infection. ( 6.1 ) Ankylosing Spondylitis (incidence ≥ 2%): upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash and vulvovaginal mycotic infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. Plaque Psoriasis Clinical Trials In clinical trials, a total of 1,789 subjects with plaque psoriasis were treated with BIMZELX. Of these, 1,073 subjects were exposed to BIMZELX for at least one year.
The safety of BIMZELX was evaluated in two placebo-controlled trials (Ps-1 and Ps-2), an active-controlled trial (Ps-3), and an open-label extension trial. Data from Trials Ps-1 and Ps-2 in 839 subjects (mean age 45 years, 72% male, 84% White) were pooled to evaluate the safety of BIMZELX in comparison to placebo up to 16 weeks after treatment initiation. A total of 670 subjects were treated during this initial period with BIMZELX 320 mg at Weeks 0, 4, 8, 12, and 16.
Table 1 summarizes the adverse reactions that occurred at a rate of 1% or greater and at a higher rate in the BIMZELX group than the placebo group. Table 1: Adverse Reactions Occurring in ≥1% of Subjects with Plaque Psoriasis in the BIMZELX Group and More Frequently than in the Placebo Group in Trials Ps-1 and Ps-2 BIMZELX N=670 n (%) Placebo N=169 n (%) URI Upper Respiratory Infections include nasopharyngitis, upper respiratory tract infection, pharyngitis, rhinitis, viral upper respiratory tract infection, tonsillitis, sinusitis, pharyngitis streptococcal, pharyngitis bacterial, peritonsillar abscess, viral rhinitis, and influenza 102 (15) 24 (14) Oral Candidiasis Oral Candidiasis includes oral candidiasis, oropharyngeal candidiasis, oral fungal infection, fungal pharyngitis, and oropharyngitis fungal 61 (9) 0 (0) Headache 22 (3) 0 (0) Injection Site Reactions Injection Site Reactions include injection site reaction, injection site erythema, injection site pain, injection site edema, injection site bruising, and injection site swelling 19 (3) 2 (1) Tinea Infections Tinea Infections include tinea pedis, fungal skin infection, tinea versicolor, tinea cruris, tinea infection, body tinea, and onychomycosis 18 (3) 1 (1) Gastroenteritis Gastroenteritis includes Enterovirus infection, gastroenteritis, gastroenteritis bacterial, and gastroenteritis viral 12 (2) 0 (0) Herpes Simplex Infections Herpes Simplex Infections include herpes simplex and oral herpes 9 (1) 0 (0) Acne 8 (1) 0 (0) Folliculitis 8 (1) 0 (0) Other Candida Infections Other Candida Infections include vulvovaginal candi… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP450 Substrates The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with BIMZELX may modulate serum levels of some cytokines. Therefore, upon initiation or discontinuation of BIMZELX in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.
Population pharmacokinetic (PK) data analyses indicated that the clearance of BIMZELX was not impacted by concomitant administration of cDMARDs including methotrexate, or by prior exposure to biologics.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BIMZELX during pregnancy. For more information, healthcare providers or patients can contact the Organization of Teratology Information Specialists (OTIS) AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. Risk Summary Available data from case reports on BIMZELX use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, BIMZELX may be transmitted from the mother to the developing fetus (see Clinical Considerations ) . In an enhanced pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of bimekizumab-bkzx during the period of organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD) (see Data ) .
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions: Because bimekizumab-bkzx may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to BIMZELX in utero. There are no data regarding infant serum levels of bimekizumab-bkzx at birth and the duration of persistence of bimekizumab-bkzx in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 4 months after birth may be considered because of the half-life of the product.
Data Animal Data: An enhanced pre- and postnatal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered subcutaneous doses of bimekizumab-bkzx of 20 or 50 mg/kg/week from gestation day 20 to parturition and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study.
There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology or neurobehavioral development. The no observed adverse effect level (NOAEL) for both maternal and developmental toxicity was identified as 50 mg/kg/week (38 times the MRHD, based on mg/kg comparison of 1.33 mg/kg/week administered as a 320 mg dose to a 60 kg individual once every 4 weeks).
8.2Lactation Risk Summary There are no data on the presence of bimekizumab-bkzx in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Endogenous IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to bimekizumab-bkzx are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BIMZELX and any potential adverse effects on the breastfed infant from BIMZELX or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of BIMZELX in pediatric patients have not been established.
8.5Geriatric Use Of the 1,789 subjects with plaque psoriasis that were exposed to BIMZELX, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or olde… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BIMZELX during pregnancy. For more information, healthcare providers or patients can contact the Organization of Teratology Information Specialists (OTIS) AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. Risk Summary Available data from case reports on BIMZELX use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, BIMZELX may be transmitted from the mother to the developing fetus (see Clinical Considerations ) . In an enhanced pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of bimekizumab-bkzx during the period of organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD) (see Data ) .
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions: Because bimekizumab-bkzx may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to BIMZELX in utero. There are no data regarding infant serum levels of bimekizumab-bkzx at birth and the duration of persistence of bimekizumab-bkzx in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 4 months after birth may be considered because of the half-life of the product.
Data Animal Data: An enhanced pre- and postnatal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered subcutaneous doses of bimekizumab-bkzx of 20 or 50 mg/kg/week from gestation day 20 to parturition and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study.
There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology or neurobehavioral development. The no observed adverse effect level (NOAEL) for both maternal and developmental toxicity was identified as 50 mg/kg/week (38 times the MRHD, based on mg/kg comparison of 1.33 mg/kg/week administered as a 320 mg dose to a 60 kg individual once every 4 weeks).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of BIMZELX in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1,789 subjects with plaque psoriasis that were exposed to BIMZELX, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PSO did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects . Of the 1,197 subjects with PsA that were exposed to BIMZELX, a total of 148 were 65 years of age and older.
Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in PsA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects . Of the 244 subjects with nr-axSpA that were exposed to BIMZELX, a total of 6 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in nr-axSpA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .
Of the 330 subjects with AS that were exposed to BIMZELX, a total of 11 were 65 years of age and older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the clinical trial in AS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects . Of the 995 subjects with hidradenitis suppurativa that were exposed to BIMZELX, a total of 18 were 65 years of age and older.
Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, clinical trials in HS did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.
12.2Pharmacodynamics Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin, and lesional skin in HS. Bimekizumab-bkzx exposure-response relationships to serum biomarkers, including IL-17A and IL-17F, and the time course of such pharmacodynamic responses are unknown. Immune Response to Inactivated or Non-Live Vaccines Healthy individuals who received a single 320 mg dose of BIMZELX two weeks prior to vaccination with an inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive BIMZELX prior to vaccination.
The effectiveness of inactivated seasonal influenza vaccines and other inactivated and non-live vaccines has not been evaluated in patients treated with BIMZELX.
12.3Pharmacokinetics Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) μg/mL and was reached in 3-4 days. Bimekizumab-bkzx exhibited dose-proportional pharmacokinetics in patients with plaque psoriasis over a dose range of 64 mg to 480 mg (0.2 to 1.5 times the approved recommended dosage) following subcutaneous administration.
The median steady-state trough concentration of bimekizumab-bkzx was approximately 40% lower in HS subjects than that of PSO subjects. Absorption The absolute bioavailability of bimekizumab-bkzx was 70% in healthy subjects. Distribution The median volume of distribution at steady state was
11.2L in subjects with moderate to severe plaque psoriasis. The volume of distribution in subjects with moderate to severe hidradenitis suppurativa was estimated to be approximately 18% higher than in subjects with moderate to severe plaque psoriasis. Elimination The median (coefficient of variation %) clearance (CL/F) of bimekizumab-bkzx was 0.337 L/day (32.7%).
The mean terminal elimination half-life was 23 days, with clearance independent of dose. The apparent clearance in subjects with moderate to severe hidradenitis suppurativa was estimated to be approximately 31% higher than in subjects with moderate to severe plaque psoriasis. Metabolism: Bimekizumab-bkzx is expected to be degraded into small peptides by catabolic pathways.
Specific Populations No significant differences in the pharmacokinetics of bimekizumab-bkzx were observed based on age (≥18 years). Body Weight: The average plasma concentration in adult subjects weighing ≥120 kg was predicted to be at least 30% lower than those weighing < 120 kg (median of 87 kg) [see Dosage and Administration (2.2) ].
12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of BIMZELX or of other bimekizumab products. Across the pivotal trials in all indications, there was no identified clinically significant effect of anti-bimekizumab-bkzx antibodies, including neutralizing anti-drug antibodies, on safety or effectiveness of BIMZELX.
Plaque Psoriasis During the 52–56-week treatment period in Trial Ps-1, Trial Ps-2, and Trial Ps-3 [see Clinical Studies (14.1) ], 116/257 (45%) of BIMZELX-treated subjects (at the recommen… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution. Each prefilled autoinjector or prefilled syringe contains 1 mL or 2 mL of a 160 mg/mL solution. The autoinjectors and prefilled syringes are not made with natural rubber latex.
BIMZELX is supplied as: BIMZELX autoinjector: NDC 50474-781-85: Carton of two 160 mg/mL single-dose autoinjectors. Each prefilled autoinjector is fixed with a 27 gauge ½ inch needle. NDC 50474-781-84: Carton of one 160 mg/mL single-dose autoinjector.
The prefilled autoinjector is fixed with a 27 gauge ½ inch needle. NDC 50474-782-84: Carton of one 320 mg/2 mL (160 mg/mL) single-dose autoinjector fixed with a 27 gauge ½ inch needle. BIMZELX prefilled syringe: NDC 50474-780-79: Carton of two 160 mg/mL single-dose prefilled syringes.
Each prefilled syringe is fixed with a 27 gauge ½ inch needle with needle guard. NDC 50474-780-78: Carton of one 160 mg/mL single dose prefilled syringe. The prefilled syringe is fixed with a 27 gauge ½ inch needle with a needle guard.
NDC 50474-783-78: Carton of one 320 mg/2 mL (160 mg/mL) single-dose prefilled syringe with a 27 gauge ½ inch needle. Storage and Handling Store cartons with BIMZELX refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect it from light until the time of use.
Do not freeze. Do not shake. Do not use beyond expiration date.
BIMZELX does not contain a preservative; discard any unused portion. When necessary, BIMZELX prefilled syringes or autoinjectors may be stored at room temperature up to 25°C (77°F) in the original carton for a single period of up to 30 days. Once BIMZELX prefilled syringes or autoinjectors have been stored at room temperature, do not place back in refrigerator.
Write the date removed from the refrigerator in the space provided on the carton and discard if not used within a 30-day period.
📦 Storage and Handling ▾
Storage and Handling Store cartons with BIMZELX refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect it from light until the time of use. Do not freeze.
Do not shake. Do not use beyond expiration date. BIMZELX does not contain a preservative; discard any unused portion.
When necessary, BIMZELX prefilled syringes or autoinjectors may be stored at room temperature up to 25°C (77°F) in the original carton for a single period of up to 30 days. Once BIMZELX prefilled syringes or autoinjectors have been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within a 30-day period.
📋 Description ▾
11 DESCRIPTION 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Instructions Instruct patients or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique [see Dosage and Administration (2.9) , Instructions for Use]. If two separate 160 mg injections are used to achieve the recommended dose, instruct patients or caregivers to administer each injection subcutaneously at a different anatomic location [see Dosage and Administration (2.9) ] .
Instruct patients or caregivers in the technique of needle and syringe disposal [see Instructions for Use] . Advise patients if they forget to take their dose of BIMZELX to inject their dose as soon as they remember. Instruct patients to then take their next dose at the appropriate scheduled time [see Dosage and Administration (2.7 )] .
Suicidal Ideation and Behavior Instruct patients and their caregivers to monitor for the emergence of suicidal ideation and behavior and promptly seek medical attention if the patient experiences suicidal ideation or behavior; or new onset or worsening depression, anxiety, or other mood changes. Instruct patients to call the National Suicide and Crisis Lifeline at 988 if they experience suicidal ideation or behavior [see Warnings and Precautions (5.1) ]. Infections Inform patients that BIMZELX may lower the ability of their immune system to fight infections.
Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.2) ] . Liver Biochemical Abnormalities Inform patients that BIMZELX may increase the risk of elevated liver enzymes. Acute liver disease or cirrhosis may increase this risk.
Advise patients that laboratory evaluation is needed prior to and periodically during treatment. Advise patients to hold the next dose of BIMZELX and call their healthcare provider right away, if signs or symptoms of liver dysfunction occur [see Warnings and Precautions (5.4) ] . Inflammatory Bowel Disease Instruct patients to seek medical advice if they develop signs and symptoms of Crohn's disease or ulcerative colitis [see Warnings and Precautions (5.5) ] .
Immunizations Advise patients to avoid vaccination with live vaccines during BIMZELX treatment. Instruct patients to inform their healthcare practitioner that they are taking BIMZELX prior to a potential vaccination [see Warnings and Precautions (5.6) ] . Pregnancy Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in patients exposed to BIMZELX during pregnancy [see Use in Specific Populations (8.1) ] .
💬 Medication Guide ▾
MEDICATION GUIDE BIMZELX ® (bim zel'ex) (bimekizumab-bkzx) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: November 2024 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://moth… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) μg/mL and was reached in 3-4 days. Bimekizumab-bkzx exhibited dose-proportional pharmacokinetics in patients with plaque psoriasis over a dose range of 64 mg to 480 mg (0.2 to 1.5 times the approved recommended dosage) following subcutaneous administration.
The median steady-state trough concentration of bimekizumab-bkzx was approximately 40% lower in HS subjects than that of PSO subjects. Absorption The absolute bioavailability of bimekizumab-bkzx was 70% in healthy subjects. Distribution The median volume of distribution at steady state was
11.2L in subjects with moderate to severe plaque psoriasis. The volume of distribution in subjects with moderate to severe hidradenitis suppurativa was estimated to be approximately 18% higher than in subjects with moderate to severe plaque psoriasis. Elimination The median (coefficient of variation %) clearance (CL/F) of bimekizumab-bkzx was 0.337 L/day (32.7%).
The mean terminal elimination half-life was 23 days, with clearance independent of dose. The apparent clearance in subjects with moderate to severe hidradenitis suppurativa was estimated to be approximately 31% higher than in subjects with moderate to severe plaque psoriasis. Metabolism: Bimekizumab-bkzx is expected to be degraded into small peptides by catabolic pathways.
Specific Populations No significant differences in the pharmacokinetics of bimekizumab-bkzx were observed based on age (≥18 years). Body Weight: The average plasma concentration in adult subjects weighing ≥120 kg was predicted to be at least 30% lower than those weighing < 120 kg (median of 87 kg) [see Dosage and Administration (2.2) ].
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin, and lesional skin in HS. Bimekizumab-bkzx exposure-response relationships to serum biomarkers, including IL-17A and IL-17F, and the time course of such pharmacodynamic responses are unknown. Immune Response to Inactivated or Non-Live Vaccines Healthy individuals who received a single 320 mg dose of BIMZELX two weeks prior to vaccination with an inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive BIMZELX prior to vaccination.
The effectiveness of inactivated seasonal influenza vaccines and other inactivated and non-live vaccines has not been evaluated in patients treated with BIMZELX.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Plaque Psoriasis Three multicenter, randomized, double-blind trials [Trial Ps-1 (NCT03370133), Trial Ps-2 (NCT03410992), and Trial Ps-3 (NCT03412747)] enrolled a total of 1,480 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, an Investigator's Global Assessment (IGA) score of ≥3 ("moderate") in the overall assessment of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12. In Trial Ps-1, 567 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks, ustekinumab (for subjects weighing ≤100kg, 45 mg initially and 4 weeks later, then every 12 weeks; for subjects weighing >100kg, 90 mg initially and 4 weeks later, then every 12 weeks), or placebo through Week 52.
At Week 16, subjects originally randomized to placebo received BIMZELX 320 mg every 4 weeks through Week 52. In Trial Ps-2, 435 subjects were randomized to either BIMZELX 320 mg by subcutaneous injection every 4 weeks or placebo. At Week 16, subjects who achieved a PASI 90 response continued into a 40-week randomized withdrawal period.
Subjects originally randomized to BIMZELX 320 mg every 4 weeks were re-randomized to either BIMZELX 320 mg every 4 weeks or BIMZELX 320 mg every 8 weeks or placebo. Subjects originally randomized to placebo continued to receive placebo if they were PASI 90 responders. Subjects who did not achieve a PASI 90 response at week 16 entered an open-label escape arm and received BIMZELX 320 mg every 4 weeks for 12 weeks.
Subjects who relapsed, defined as having a less than PASI 75 response compared to baseline, during the randomized withdrawal period also entered the 12-week escape arm. In Trial Ps-3, 478 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks through week 56, BIMZELX 320 mg every 4 weeks through week 16 followed by BIMZELX every 8 weeks through week 56, or adalimumab (80 mg as an initial dose followed by 40 mg every other week starting 1 week after initial dose through Week 24) followed by BIMZELX 320 mg every 4 weeks through Week 56.
In Trial Ps-1, Trial Ps-2, and Trial Ps-3, 71% of the subjects were male and 84% of the subjects were White, with a mean age of 45 years and a mean weight of 89 kg. At baseline, subjects had a median baseline PASI score of 18, median baseline for BSA of 20%, and baseline IGA score of 4 ("severe") in 33% of subjects. A total of 93% subjects had psoriasis of the scalp (Scalp IGA score of ≥1) and a total of 26% of subjects had a history of psoriatic arthritis.
Additionally, 38% had received prior biologic therapy. Clinical Response at Week 16 (Trial Ps-1 and Trial Ps-2) Trial Ps-1 and Trial Ps-2 responses at Week 16 compared to placebo for the two co-primary endpoints: The proportion of subjects who achieved an IGA score of 0 ("clear") or 1 ("almost clear") with at least a 2-grade improvement from baseline The proportion of subjects who achieved at least a 90% reduction from baseline PASI (PASI 90) Secondary endpoints included the proportion of subjects who achieved PASI 100, IGA 0, and Scalp IGA response (defined as Scalp IGA score of 0 [clear] or 1 [almost clear] with at least 2-grade of improvement from baseline) at Week 16, and PASI 75 at Week 4.
In addition, secondary endpoints included assessment of psoriasis symptoms (itching, pain, and scaling) measured by the Patient Symptom Diary (PSD) at Week 16. The proportion of subjects who achieved IGA 0 or 1, PASI 90, IGA 0, and PASI 100 response at Week 16 are presented in Table 3. Table 3: Efficacy Results at Week 16 in BIMZELX or Placebo-Treated Adults with Plaque Psoriasis in Trial Ps-1 and Trial Ps-2 Trial Ps-1 Trial Ps-2 BIMZELX 320 mg every 4 weeks (N=321) n (%) Placebo (N=83) n (%) BIMZELX 320 mg every 4 weeks (N=349) n (%) Placebo (N=86) n (%) IGA 0 or 1 ("clear" or "almost clear") Co-primary endpoints 270 (84%) 4 (… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with bimekizumab-bkzx. No effects on fertility parameters such as effects on reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were subcutaneously administered 200 mg/kg/week bimekizumab-bkzx (150 times the MRHD, based on mg/kg comparison) for 26 weeks. The monkeys were not mated to evaluate fertility.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with bimekizumab-bkzx. No effects on fertility parameters such as effects on reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were subcutaneously administered 200 mg/kg/week bimekizumab-bkzx (150 times the MRHD, based on mg/kg comparison) for 26 weeks. The monkeys were not mated to evaluate fertility.
📖 Instructions for Use ▾
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 not share or reuse your BIMZELX autoinjector. You may give or get an infection.
Do not remove the needle cap until just before you give the injection. If you have vision or hearing problems, do not use 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 not place 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 not use 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 minutes to warm to room temperature.
This will help to reduce discomfort when injecting. Do not microwave the autoinjector, run hot water over it, or leave it in direct sunlight. Do not shake the autoinjector.
Do not take 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 o… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1.2 , 1.3 , 1.4 , 1.5 ) 11/2024 Dosage and Administration ( 2.3 , 2.4 , 2.5 , 2.6 , 2.7 ) 11/2024 Warnings and Precautions ( 5.1 , 5.2 ) 11/2024
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 160 mg/mL Autoinjector Carton NDC 50474-781-85 Rx ONLY ATTENTION: Dispense enclosed Medication Guide to each patient. Bimzelx ® (bimekizumab-bkzx) Injection 160 mg/mL per autoinjector FOR SUBCUTANEOUS USE ONLY Two single-dose autoinjectors. Each autoinjector delivers 160 mg in 1 mL of bimekizumab-bkzx. For a 320 mg dose, two 160 mg autoinjectors are required. PRINCIPAL DISPLAY PANEL - 160 mg/mL Autoinjector Carton
PRINCIPAL DISPLAY PANEL - 160 mg/mL Syringe Carton NDC 50474-780-79 Rx ONLY ATTENTION: Dispense enclosed Medication Guide to each patient. Bimzelx ® (bimekizumab-bkzx) Injection 160 mg/mL per syringe FOR SUBCUTANEOUS USE ONLY Two single-dose prefilled syringes. Each syringe delivers 160 mg in 1 mL of bimekizumab-bkzx. For a 320 mg dose, two 160 mg prefilled syringes are required. PRINCIPAL DISPLAY PANEL - 160 mg/mL Syringe Carton
PRINCIPAL DISPLAY PANEL - 320 mg/2 mL autoinjector Carton NDC 50474-782-84 Rx ONLY ATTENTION: Dispense enclosed Medication Guide to each patient. Bimzelx ® (bimekizumab-bkzx) Injection 320 mg/2 mL autoinjector FOR SUBCUTANEOUS USE ONLY One single-dose autoinjector. Each autoinjector delivers 320 mg in 2 mL of bimekizumab-bkzx. PRINCIPAL DISPLAY PANEL - 320 mg/2 mL autoinjector Carton
PRINCIPAL DISPLAY PANEL - 320 mg/2 mL Syringe Carton NDC 50474-783-78 Rx ONLY ATTENTION: Dispense enclosed Medication Guide to each patient. Bimzelx ® (bimekizumab-bkzx) Injection 320 mg/2 mL (160 mg/mL) syringe FOR SUBCUTANEOUS USE ONLY One single-dose prefilled syringe. Each syringe delivers 320 mg in 2 mL of bimekizumab-bkzx. PRINCIPAL DISPLAY PANEL - 320 mg/2 mL Syringe Carton
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