Risankizumab

SKYRIZI

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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

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FDA dosing	Population	Start	Target
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)

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.

NO BOXED WARNINGS