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Skyrizi (risankizumab-rzaa)
risankizumab
Adult Dosing .
Dosage forms: INJ (auto-injector): 150 mg; INJ (pre-filled syringe): 150 mg per mL, 180 mg per 1.2 mL; INJ (on-body injector): 180 mg, 360 mg; INJ (vial): various
Special Note
- [drug name clarification]
- Info: nonproprietary name = risankizumab-rzaa
psoriasis, moderate-severe plaque
- [150 mg SC q12wk]
- Start: 150 mg SC x1 on wk 0, 4, then q12wk
psoriatic arthritis
- [150 mg SC q12wk]
- Start: 150 mg SC x1 on wk 0, 4, then q12wk; Info: use alone or with non-biologic DMARDs
Crohn disease, moderate-severe
- [induction tx]
- Dose: 600 mg IV x1 on wk 0, 4, 8
- [maintenance tx]
- Dose: 180 mg or 360 mg SC q8wk; Start: 4wk after last induction dose; Info: use lowest effective dose
ulcerative colitis, moderate-severe
- [induction tx]
- Dose: 1200 mg IV x1 on wk 0, 4, 8
- [maintenance tx]
- Dose: 180 mg or 360 mg SC q8wk; Start: 4wk after last induction dose; Info: use lowest effective dose
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [Crohn disease]
- hepatic impairment: not defined; Info: consider alternative tx if cirrhosis
- [all other indications]
- hepatic impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- TB infection, active
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: TB infection, latent
- caution: TB infection risk
- caution: cirrhosis (Crohn disease or ulcerative colitis use)
Drug Interactions .
Overview
risankizumab
IL-23 antagonist
- immunomodulatory effects
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
- 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
- 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
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- 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
- 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
- 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
- hypersensitivity reaction
- anaphylaxis
- infection
- hepatotoxicity (Crohn disease use)
- hepatic injury (Crohn disease use)
Common Reactions
- infection
- URI
- arthralgia
- abdominal pain
- headache
- injection site reaction
- fever
- anemia
- back pain
- rash
- arthropathy
- UTI
- fatigue
- hypersensitivity reaction
- ALT incr.
- cholesterol incr.
Safety/Monitoring .
Monitoring Parameters
Crohn Disease or Ulcerative Colitis: TB test before tx start; ALT, AST, bilirubin at baseline, then during induction tx for at least 12wk of tx, then as clinically indicated
All Other Indications: TB test before tx start
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, though risk of neonatal death based on animal data at 5x and 32x MRHD; possible risk of neonatal immunosuppression based on drug's mechanism of action
Pregnancy Registry
encourage patients to enroll in Pregnancy Exposure Registry at 1-877-302-2161 or www.glowpregnancyregistry.com
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 risankizumab: catabolism; CYP450: unknown
Excretion: for risankizumab: unknown; Half-life: 21 days (Crohn disease use), 28 days (psoriasis use)
Subclass: Inflammatory Bowel Disease (IBD) ; Interleukin-23 (IL-23) Antagonists ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
for risankizumab: 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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