ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : -27 مورد

Bimekizumab: Drug information

Bimekizumab: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Bimekizumab: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Bimzelx
Brand Names: Canada
  • Bimzelx
Pharmacologic Category
  • Anti-interleukin 17-Receptor Antibody;
  • Antipsoriatic Agent;
  • Monoclonal Antibody
Dosing: Adult

Dosage guidance:

Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and age-appropriate vaccinations should be up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

Ankylosing spondylitis

Ankylosing spondylitis: SUBQ: 160 mg once every 4 weeks (Ref).

Axial spondyloarthritis, nonradiographic

Axial spondyloarthritis, nonradiographic: SUBQ: 160 mg once every 4 weeks (Ref).

Hidradenitis suppurativa, moderate to severe

Hidradenitis suppurativa, moderate to severe: SUBQ: 320 mg once every 2 weeks for the first 16 weeks (9 doses), and then every 4 weeks thereafter.

Plaque psoriasis, moderate to severe

Plaque psoriasis, moderate to severe: SUBQ: 320 mg once every 4 weeks for the first 16 weeks (5 doses), and then every 8 weeks thereafter.

Psoriatic arthritis

Psoriatic arthritis

Note: For patients with psoriatic arthritis and coexisting moderate to severe plaque psoriasis, use the dosing regimen for plaque psoriasis.

SUBQ: 160 mg once every 4 weeks (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

Hepatic impairment prior to treatment initiation

Child-Turcotte-Pugh class A to C: Avoid use.

Acute hepatotoxicity during treatment

If treatment-related increase in liver transaminases occurs, interrupt therapy and permanently discontinue if bimekizumab-induced liver injury is confirmed.

Dosing: Obesity: Adult

Plaque psoriasis, moderate to severe: ≥120 kg: SUBQ: 320 mg once every 4 weeks.

Dosing: Adjustment for Toxicity: Adult

Active infection: Discontinue therapy if patient develops active infection that is not responding to conventional therapy.

Inflammatory bowel disease: Therapy should be discontinued for new or worsening signs or symptoms of active inflammatory bowel disease.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Immunologic: Antibody development (44% to 59%; neutralizing: 16% to 63%)

Infection: Infection (27% to 36%; including candidiasis [4% to 7%], herpes simplex infection [1%], oral candidiasis [2% to 9%], serious infection [<1%], upper respiratory tract infection [14% to 15%], urinary tract infection [≤3%])

1% to 10%:

Dermatologic: Acne vulgaris (1%), folliculitis (1%), skin rash (3%), tinea (3%)

Gastrointestinal: Diarrhea (3%), gastroenteritis (2%), stomatitis (1%)

Genitourinary: Vulvovaginal candidiasis (2%)

Hematologic & oncologic: Neutropenia (≤1%)

Hepatic: Increased serum transaminases (1% to 2%)

Local: Injection-site reaction (3%; including bruising at injection site, erythema at injection site, pain at injection site, swelling at injection site)

Nervous system: Fatigue (1% to 2%), headache (3% to 4%), suicidal ideation (2%; including suicidal tendencies)

Neuromuscular & skeletal: Musculoskeletal pain (2%), myalgia (2%)

Respiratory: Bronchitis (2%), cough (2%), nasopharyngitis (≤3%), oropharyngeal pain (1%), tonsillitis (2%)

<1%:

Dermatologic: Eczema

Otic: Otitis externa, otitis media

Miscellaneous: Fever

Frequency not defined: Gastrointestinal: Inflammatory bowel disease (including Crohn disease, ulcerative colitis)

Postmarketing:

Gastrointestinal: Esophageal candidiasis

Ophthalmic: Conjunctivitis

Contraindications

There are no contraindications listed in the US manufacturer’s labeling.

Canadian labeling: Hypersensitivity to bimekizumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Infections: May increase the risk of infections, including severe infection. A higher rate of infections was observed with bimekizumab treatment in clinical trials, including upper respiratory tract, oral candidiasis, tinea, gastroenteritis, and herpes simplex infections. Bimekizumab should not be initiated in patients with untreated, active infections.

• Liver biochemical abnormalities: Use of bimekizumab is associated with an increase in liver serum transaminases >3 times ULN, which resolved with discontinuation.

• Suicidal ideation: Patients without a prior history of suicidal ideation or behavior and being treated for hidradenitis suppurativa, plaque psoriasis, or psoriatic arthritis experienced a higher rate of suicidal ideation during therapy.

• Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection (latent TB) prior to initiating therapy; do not initiate therapy in patients with TB disease (active TB). Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of TB infection or disease.

Disease-related concerns:

• Depression or suicidal ideation: During an open-label extension trial, 1 completed suicide was reported. Use in patients with a history of severe depression or suicidal ideation should be weighed against the benefits of using bimekizumab.

• Inflammatory bowel disease: Treatment with bimekizumab may cause Crohn disease and ulcerative colitis, including exacerbations. Use is not recommended in patients with active inflammatory bowel disease.

• Preexisting liver disease or cirrhosis: Patients with preexisting liver disease or cirrhosis may be at increased risk for severe hepatic injury.

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous:

Bimzelx: 160 mg/mL (1 mL); Bimekizumab-bkzx 320 mg/2 mL (2 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous:

Bimzelx: 160 mg/mL (1 mL); Bimekizumab-bkzx 320 mg/2 mL (2 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution Auto-injector (Bimzelx Subcutaneous)

160 mg/mL (per mL): $9,507.46

320 mg/2 mL (per mL): $9,507.46

Solution Prefilled Syringe (Bimzelx Subcutaneous)

160 mg/mL (per mL): $9,507.46

320 mg/2 mL (per mL): $9,507.46

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous:

Bimzelx: 160 mg/mL (1 mL); Bimekizumab-bkzx 320 mg/2 mL (2 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous:

Bimzelx: 160 mg/mL (1 mL); Bimekizumab-bkzx 320 mg/2 mL (2 mL) [contains polysorbate 80]

Administration: Adult

SUBQ: Allow to reach room temperature prior to injection (30 to 45 minutes) without removing prefilled syringe or autoinjector from carton to protect from light. Administer into the thigh, abdomen (≥2 inches from the navel) or back of upper arm; for a dose of 320 mg where 2 separate 160 mg injections are used, administer as 2 SUBQ injections into 2 different anatomical sites (eg, thighs, abdomen [≥2 inches from the navel], back of upper arm). Injections may be administered in the upper, outer arm only by a health care provider or caregiver. Rotate injection site with each injection. Do not inject into areas of skin that are tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Bimzelx: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s005s006s007lbl.pdf#page=29

Use: Labeled Indications

US labeling:

Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adults.

Axial spondyloarthritis, nonradiographic: Treatment of active nonradiographic axial spondyloarthritis with objective signs of inflammation in adults.

Hidradenitis suppurativa, moderate to severe: Treatment of moderate to severe hidradenitis suppurativa in adults.

Plaque psoriasis, moderate to severe: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.

Canadian labeling:

Axial spondyloarthritis: Treatment of axial spondyloarthritis including active radiographic spondyloarthritis who have inadequate response or are intolerant to conventional therapy and active nonradiographic axial spondyloarthritis with objective signs of inflammation (eg, elevated C-reactive protein) who have inadequate response or intolerance to nonsteroidal anti-inflammatory drugs.

Plaque psoriasis, moderate to severe: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adults, alone or in combination with a conventional nonbiologic disease-modifying antirheumatic drug (eg, methotrexate).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Anifrolumab: Biologic Anti-Psoriasis Agents may increase immunosuppressive effects of Anifrolumab. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Belimumab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider Therapy Modification

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Bimekizumab may decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

InFLIXimab: May increase immunosuppressive effects of Biologic Anti-Psoriasis Agents. Risk X: Avoid

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Pregnancy Considerations

Bimekizumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Data collection to monitor pregnancy and infant outcomes following exposure to bimekizumab is ongoing. Health care providers are encouraged to enroll patients exposed to bimekizumab during pregnancy in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases Study (1-877-311-8972 or http://mothertobaby.org/pregnancy-studies/); patients may also enroll themselves.

Breastfeeding Considerations

It is not known if bimekizumab is present in breast milk.

Bimekizumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Prior to therapy start:

• Evaluate for malignancy (especially skin cancer); current or latent infections, lymphadenopathy; signs and symptoms of inflammatory bowel disease; ensure age-appropriate vaccinations are up to date and, in general, no live vaccines are administered within 4 weeks of starting therapy (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

• Labs: CBC with differential; complete metabolic panel; testing for tuberculosis (TB) infection (latent TB) (eg, Quantiferon Gold) or interferon gamma release assay for TB in patients who have had Bacillus Calmette-Guerin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (HBV) (HBsAg, HBsAb, HBVAbcore), hepatitis C virus antibody, HIV, pregnancy test, C-reactive protein (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]).

During therapy:

• Evaluate for infection, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), infusion/injection site reactions, exacerbation or development of inflammatory bowel disease (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]).

• Labs: CBC and LFTs every 3 to 6 months, pregnancy test as needed; yearly testing/chest radiograph for TB in high-risk patients (eg, contact with individuals with TB disease [active TB]) (AAD-NPF [Menter 2019]; EuroGuiDerm [Nast 2024]); hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (AAD-NPF [Menter 2019]).

After therapy:

Periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD-NPF [Menter 2019]).

Mechanism of Action

Bimekizumab is a humanized IgG1/k monoclonal antibody that selectively binds with the interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17AF (IL-17AF) cytokines and inhibits its 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 inhibits the release of proinflammatory cytokines and chemokines.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vdss: 11.2 L in patients with moderate to severe plaque psoriasis; estimated to be ~18% higher in patients with moderate to severe hidradenitis suppurativa.

Metabolism: Expected to be degraded into small peptides and amino acids via catabolic pathways.

Bioavailability: 70%.

Half-life elimination: 23 days.

Time to peak: 3 to 4 days.

Excretion: Clearance: 0.337 L/day; estimated to be ~31% higher in patients with moderate to severe hidradenitis suppurativa.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: In adult patients weighing ≥120 kg, plasma concentrations were predicted to be at least 30% lower than in adult patients weighing <120 kg.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (QA) Qatar: Bimzelx
  1. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
  2. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024;83(2):199-213. doi:10.1136/ard-2023-224803 [PubMed 37793792]
  3. Bimzelx (bimekizumab) [prescribing information]. Smyrna, GA: UCB Inc; November 2024.
  4. Bimzelx (bimekizumab) [product monograph]. Oakville, Ontario, Canada: UCB Canada Inc; November 2024.
  5. Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
  6. Coates LC, McInnes IB, Merola JF, et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: three-year results from a phase IIb randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022;74(12):1959-1970. doi:10.1002/art.42280 [PubMed 35829656]
  7. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25-37. doi:10.1016/S0140-6736(22)02302-9 [PubMed 36493791]
  8. Mease PJ, Asahina A, Gladman DD, et al. Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE. Rheumatology (Oxford). 2023;62(2):617-628. doi:10.1093/rheumatology/keac353 [PubMed 35789257]
  9. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057 [PubMed 30772098]
  10. Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38-48. doi:10.1016/S0140-6736(22)02303-0 [PubMed 36495881]
  11. Nast A, Spuls PI, Dressler C, et al; European Dermatology Forum, European Centre for Guidelines Development. EuroGuiDerm guideline for the systemic treatment of psoriasis vulgaris. https://www.guidelines.edf.one/guidelines/psoriasis-guideline. Updated March 2024. Accessed October 24, 2024.
  12. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
  13. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
  14. Refer to manufacturer’s labeling.
  15. Ritchlin CT, Coates LC, McInnes IB, et al. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023;82(11):1404-1414. doi:10.1136/ard-2023-224431 [PubMed 37696588]
  16. Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020;395(10222):427-440. doi:10.1016/S0140-6736(19)33161-7 [PubMed 32035552]
  17. Singh JA, Guyatt G, Ogdie A, et al. Special article: 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726 [PubMed 30499246]
  18. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023;82(4):515-526. doi:10.1136/ard-2022-223595 [PubMed 36649967]
Topic 138686 Version 84.0