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Tremfya
guselkumab
Adult Dosing .
Dosage forms: INJ (One-Press SC auto-injector): 100 mg; INJ (Tremfya SC pen): 100 mg per injection, 200 mg per injection; INJ (SC pre-filled syringe): 100 mg per mL, 200 mg per 2 mL; INJ (IV vial): various
psoriasis, moderate-severe plaque
- [100 mg SC q8wk]
- Start: 100 mg SC x1 on wk 0, 4, then q8wk
psoriatic arthritis
- [100 mg SC q8wk]
- Start: 100 mg SC x1 on wk 0, 4, then q8wk; Info: use alone or w/ conventional DMARDs
ulcerative colitis, moderate-severe
- [induction tx]
- Dose: 200 mg IV x1 on wk 0, 4, 8 or 400 mg SC x1 on wk 0, 4, 8
- [maintenance tx]
- Dose: 100 mg SC q8wk starting 8wk after last induction dose or 200 mg SC q4wk starting 4wk after last induction dose; Info: use lowest effective dose
Crohn disease, moderate-severe
- [induction tx]
- Dose: 200 mg IV x1 on wk 0, 4, 8 or 400 mg SC x1 on wk 0, 4, 8
- [maintenance tx]
- Dose: 100 mg SC q8wk starting 8wk after last induction dose or 200 mg SC q4wk starting 4wk after last induction dose; Info: use lowest effective dose
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (One-Press auto-injector): 100 mg; INJ (Tremfya pen): 100 mg per injection; INJ (pre-filled syringe): 100 mg per mL
psoriasis, moderate-severe plaque
- [6 yo and older, >40 kg]
- Dose: 100 mg SC q8wk; Start: 100 mg SC x1 on wk 0, 4, then q8wk
psoriatic arthritis
- [6 yo and older, >40 kg]
- Dose: 100 mg SC q8wk; Start: 100 mg SC x1 on wk 0, 4, then q8wk; Info: use alone or w/ conventional DMARDs
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- TB infection, active
- infection, active
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: TB infection, latent
- caution: TB infection risk
- caution: hepatic disease
- caution: cirrhosis
Drug Interactions .
Overview
guselkumab
IL-23 antagonist
- immunomodulatory effects
- caution advised w/ drugs metabolized by CYP450 enzymes, especially w/ narrow therapeutic index; chronic inflammatory conditions may alter metabolic enzyme formation; tx w/ 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
- abrocitinib
- adalimumab
- anifrolumab
- cladribine oral
- deuruxolitinib
- etrasimod
- infliximab
- natalizumab
- pimecrolimus topical
- rabies vaccine
- ritlecitinib
- ruxolitinib topical
- tofacitinib
- 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
- temsirolimus
- tick-borne encephalitis vaccine
- typhoid vaccine
Caution Advised
- abatacept
- abemaciclib
- acalabrutinib
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- 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
- fluorouracil
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- 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
- 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
- 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
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- topotecan
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- infection, serious
- tuberculosis (Crohn disease use)
- hepatotoxicity risk
Common Reactions
- infection
- URI
- abdominal pain
- injection site reaction
- arthralgia
- headache
- diarrhea
- fatigue
- gastroenteritis
- bronchitis
- fever
- rash
- LFTs incr.
Safety/Monitoring .
Monitoring Parameters
Psoriasis and Psoriatic Arthritis: TB test before tx start; consider ALT, AST, bilirubin at baseline, then periodically as clinically indicated
Crohn Disease and Ulcerative Colitis: TB test before tx start; ALT, AST, bilirubin at baseline, then for at least 16wk of tx, then as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available, though likely to cross placenta based on human data w/ other monoclonal antibodies; no known risk of teratogenicity based on animal data at up to 18x systemic exposure, though risk of neonatal death based on animal data at 4-18x systemic exposure
Pregnancy Registry
encourage patients to enroll in MotherToBaby Pregnancy Study at 1-877-311-8972 or www.mothertobaby.org/join-study
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 guselkumab: catabolism; CYP450: unknown
Excretion: for guselkumab: unknown; Half-life: 15-18 days
Subclass: Inflammatory Bowel Disease (IBD) ; Interleukin-23 (IL-23) Antagonists ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
for guselkumab: selectively binds to p19 subunit of IL-23 and inhibits IL-23 cytokine-induced responses including release of pro-inflammatory cytokines and chemokines (monoclonal antibody)
Formulary .
No Formulary Selected
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