Risankizumab
SKYRIZI
Pronunciation: ris-an-KIZ-yoo-mab (skye-RIZ-ee)
“Sky-risin’ ankles kiss you, maybe”
What it isMonoclonal antibody against the p19 subunit of IL-23; psoriasis, psoriatic arthritis, Crohn disease and ulcerative colitis.
Why this oneIt leaves IL-12 intact, unlike ustekinumab, and offers durable skin clearance on quarterly maintenance dosing while covering both major forms of IBD.
What limits itScreen for tuberculosis and infection, avoid live vaccines, and monitor liver tests during IBD induction.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Moderate-to-severe plaque psoriasis | Adult | 150 mg SC at Week 0 and Week 4 | 150 mg SC every 12 weeks | |
| Moderate-to-severe plaque psoriasis | Peds ≥6 yr | <40 kg: 55 mg; ≥40 kg: 150 mg SC at Week 0 and Week 4 | same dose every 12 weeks | |
| Active psoriatic arthritis | Adult | 150 mg SC at Week 0 and Week 4 | 150 mg SC every 12 weeks | |
| Active psoriatic arthritis | Peds ≥6 yr | <40 kg: 55 mg; ≥40 kg: 150 mg SC at Week 0 and Week 4 | same dose every 12 weeks | |
| Moderately to severely active Crohn's disease | Adult | 600 mg IV over ≥1 h at Weeks 0, 4, 8 (induction) | 180 mg or 360 mg SC at Week 12, then every 8 weeks | |
| Moderately to severely active ulcerative colitis | Adult | 1,200 mg IV over ≥2 h at Weeks 0, 4, 8 (induction) | 180 mg or 360 mg SC at Week 12, then every 8 weeks |
Renal Undefined
Hepatic Undefined
For CD/UC maintenance, use the lowest effective dose (180 mg or 360 mg).
Instructions
- For Crohn's disease and ulcerative colitis, obtain liver enzymes and bilirubin before starting and monitor during induction (≥ first 12 weeks)
- Evaluate for tuberculosis before initiating
- Complete all age-appropriate vaccinations before starting; avoid live vaccines
- SC maintenance injected in thigh or abdomen; IV induction (CD/UC) infused over ≥1 h (600 mg) or ≥2 h (1,200 mg)
Available strengths
- inj 150 mg/mL
Contraindications
- History of a serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.
Cautions
- Serious hypersensitivity reactions, including anaphylaxis
- Increased risk of infection — do not initiate during a clinically important active infection
- Tuberculosis — evaluate before starting
- Hepatotoxicity (drug-induced liver injury reported during IBD induction)
- Avoid live vaccines
Adverse reactions
- upper respiratory infections
- headache
- fatigue
- injection site reactions
- tinea infections
- arthralgia (CD/UC)
- abdominal pain (CD)
- anemia (CD)
- pyrexia (CD/UC)
Pregnancy Human data insufficient; as a monoclonal antibody it can cross the placenta and may cause immunosuppression in the in utero-exposed infant. Increased fetal/infant loss in monkeys at high dose. Registry available.
Lactation No data on presence in human milk; consider benefits of breastfeeding against the mother's clinical need and potential effects on the infant.
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 150 mg/mL | inj | per unit | — | $22830.90/mL | not offered |
NO BOXED WARNINGS
Principal riskHypersensitivity; infections; liver injury during IBD induction
Classes and tags
Clinical profile
Legacy pregnancy categoryN/A (post-2015 labeling)
Defining liabilityInfections and IBD-induction hepatotoxicity
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