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Bimzelx (bimekizumab-bkzx)
bimekizumab
Adult Dosing .
Dosage forms: INJ (auto-injector): 160 mg, 320 mg; INJ (pre-filled syringe): 160 mg per mL, 320 mg per 2 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = bimekizumab-bkzx
psoriasis, moderate-severe plaque
- [320 mg SC q8wk]
- Start: 320 mg SC x1 at wk 0, 4, 8, 12, 16, then 320 mg SC q8wk; Info: may consider 320 mg SC q4wk after wk 16 if wt >120 kg
psoriatic arthritis
- [160 mg SC q4wk]
- Info: use plaque psoriasis dosing for patients with coexisting disease
axial spondyloarthritis, non-radiographic
- [160 mg SC q4wk]
ankylosing spondylitis
- [160 mg SC q4wk]
hidradenitis suppurativa, moderate-severe
- [320 mg SC q4wk]
- Start: 320 mg SC x1 at wk 0, 2, 4, 6, 8, 10, 12, 14, 16, then 320 mg SC q4wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- acute hepatic disease/cirrhosis: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- cirrhosis
- hepatic disease, acute
- inflammatory bowel disease, active
- infection, active
- TB infection, active
- caution: TB infection, latent
- caution: TB infection risk
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: depression history, severe
- caution: suicidality history
Drug Interactions .
Overview
bimekizumab
IL-17 antagonist
- immunomodulatory effects
- caution advised with narrow therapeutic index drugs; chronic inflammatory conditions may alter metabolic enzyme formation; tx with immune modulators may reverse this effect, resulting in altered levels of concomitant drugs
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- adalimumab
- cladribine oral
- deuruxolitinib
- etrasimod
- natalizumab
- pimecrolimus topical
- rabies vaccine
- ruxolitinib topical
- upadacitinib
Monitor/Modify Tx
- anthrax vaccine
- carfilzomib
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- everolimus
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- mitomycin
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- sipuleucel-T
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Caution Advised
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- carboplatin
- carmustine
- certolizumab pegol
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- coccidioides immitis skin test antigen
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- etuvetidigene autotemcel
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mirikizumab
- mitoxantrone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nadofaragene firadenovec intravesical
- narsoplimab
- nelarabine
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- rilonacept
- rilzabrutinib
- risankizumab
- ritlecitinib
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- sarilumab
- satralizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- suicidality
- infection, serious
- inflammatory bowel disease
Common Reactions
- infection
- URI
- candidiasis, oral
- headache
- candidiasis
- injection site reaction
- tinea infection
- diarrhea
- gastroenteritis
- UTI
Safety/Monitoring .
Monitoring Parameters
TB test before tx start; alk phos, ALT, AST, bilirubin at baseline, then as clinically indicated; signs/symptoms of depression, behavior changes, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available, though likely to cross placenta based on human data with other monoclonal antibodies; no known risk of teratogenicity based on animal data at up to 38x MRHD; possible risk of decr. neonatal immune response based on drug's mechanism of action; for infants exposed to bimekizumab in utero, weigh risk/benefit before administering live vaccines for at least 4mo after birth
Pregnancy Registry
enroll patients or encourage patients to enroll in MotherToBaby Pregnancy Studies at 1-877-311-8972 or at www.mothertobaby.org/pregnancy-studies/
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for bimekizumab: catabolism; CYP450: none
Excretion: for bimekizumab: unknown; Half-life: 23 days
Subclass: Interleukin-17 (IL-17) Antagonists ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
for bimekizumab: selectively binds to and inhibits IL-17A, IL-17F, IL-17-AF cytokines, reducing inflammation and altering immune response (monoclonal antibody)
Formulary .
No Formulary Selected
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