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 oneClears psoriasis better than ustekinumab or adalimumab, with quarterly maintenance; also covers Crohn disease and UC.
What limits itScreen for tuberculosis and infection, avoid live vaccines, and monitor liver tests during IBD induction.
Pearls
- Spares IL-12, unlike ustekinumab.
- Neutralizing antibodies can lower drug levels and efficacy.
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
FDA label
Read the full label on DailyMed ↗
NO BOXED WARNINGS
| 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 |
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Memory aids: interaction avatars
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Self-check
- Risankizumab: Which interleukin does it spare compared with ustekinumab?
IL-12. - Risankizumab: What laboratory monitoring is needed during IBD induction?
Liver tests.