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: SUBQ: 160 mg once every 4 weeks (Ref).
Axial spondyloarthritis, nonradiographic: SUBQ: 160 mg once every 4 weeks (Ref).
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: SUBQ: 320 mg once every 4 weeks for the first 16 weeks (5 doses), and then every 8 weeks thereafter.
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).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
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.
Plaque psoriasis, moderate to severe: ≥120 kg: SUBQ: 320 mg once every 4 weeks.
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.
Refer to adult dosing.
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
There are no contraindications listed in the US manufacturer’s labeling.
Canadian labeling: Hypersensitivity to bimekizumab or any component of the formulation.
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.
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]
No
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.
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]
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.
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
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).
None known.
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
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.
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.
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]).
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.
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.
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.