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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
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
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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