IL-23 inhibitor / BiologicPrescription OnlyPregnancy Cat. No adequate human data. Animal studies showed no harm at high doses. Use only if clearly needed.FDA 2019
Risankizumab
risankizumab
Risankizumab is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin-23 (IL-23) by binding to the p19 subunit. It is approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis. Risankizumab's selective IL-23 blockade (without inhibiting IL-12) preserves certain innate immune responses.
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:Skyrizi
Quick Reference
Medicine ClassIL-23 inhibitor / Biologic
FDA Approved2019
PregnancyCategory No adequate human data. Animal studies showed no harm at high doses. Use only if clearly needed.
FormsPrefilled syringe (SC), Prefilled pen (SC)
Quick Facts
- Active ingredient
- risankizumab
- Medicine class
- IL-23 inhibitor / Biologic
- Brand names
- Skyrizi
- Availability
- Prescription only (Rx)
- Pregnancy category
- No adequate human data. Animal studies showed no harm at high doses. Use only if clearly needed.
- Half-life
- Approximately 28 days.
- Major interactions
- Live attenuated vaccinesMajor
- FDA approved
- 2019
What Is Risankizumab?
Risankizumab is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin-23 (IL-23) by binding to the p19 subunit. It is approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis. Risankizumab's selective IL-23 blockade (without inhibiting IL-12) preserves certain innate immune responses.
Risankizumab (risankizumab) belongs to the IL-23 inhibitor / Biologic class of medications. It was first approved by the FDA in 2019. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Risankizumab. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Risankizumab with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Risankizumab is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
Moderate-to-severe plaque psoriasis in adults
Active psoriatic arthritis in adults (with or without biologic experience)
Moderately to severely active Crohn's disease (induction IV + maintenance SC)
Moderately to severely active ulcerative colitis in adults
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
Plaque psoriasis: 150 mg SC at weeks 0, 4, then every 12 weeks. PsA: 150 mg SC at weeks 0, 4, then every 12 weeks. Crohn's disease: 600 mg IV (3 doses at weeks 0, 4, 8 for induction), then 360 mg SC every 8 weeks for maintenance. Ulcerative colitis: 1200 mg IV (3 doses at weeks 0, 4, 8), then 180 mg SC every 8 weeks; 360 mg SC every 8 weeks for prior TNFi failure.
PD
Pediatric Dosage
Not approved for pediatric use.
RI
Renal Impairment
No dose adjustment required.
HI
Hepatic Impairment
No dose adjustment required.
Available Forms
Prefilled syringe (SC)Prefilled pen (SC)Intravenous infusion solution
Available Strengths
75 mg/0.83 mL (SC)150 mg/mL (SC)600 mg/10 mL (IV for Crohn's)1200 mg/20 mL (IV for UC)
Side Effects
Common
- Upper respiratory tract infections (most common)
- Injection site reactions
- Headache
- Fatigue
- Diarrhea (particularly with IBD indications)
- Arthralgia
Serious
- Serious infections (TB, invasive fungal infections, bacterial infections)
- Hypersensitivity reactions including anaphylaxis
- Malignancy (possible theoretical risk with long-term immunosuppression)
- Reactivation of latent infections (TB, hepatitis B)
Rare
- Angioedema
- Psoriasiform reactions (paradoxical pustular psoriasis — very rare)
- Elevated liver enzymes (usually mild, transient)
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
major
Live attenuated vaccines
Avoid co-administration; complete live vaccine series prior to initiating risankizumab.
moderate
CYP450 substrates (warfarin, cyclosporine)
Resolution of inflammation may partially restore CYP450 activity. Monitor narrow-therapeutic-index substrates.
Warnings & Contraindications
Infections: screen for tuberculosis (TB) before initiating. Do not use if active serious infection. Fungal infections: consider in patients from endemic areas.
Hypersensitivity: discontinue for anaphylaxis, angioedema, or serious allergic reaction.
Malignancy: weigh risks in patients with a known malignancy history.
Immunizations: update all recommended vaccinations before therapy. Avoid live vaccines.
How Risankizumab Works
Risankizumab selectively binds to the p19 subunit of interleukin-23 (IL-23), blocking the interaction of IL-23 with its receptor complex (IL-23R/IL-12Rβ1). Unlike ustekinumab (which blocks both IL-12 and IL-23 via the shared p40 subunit), risankizumab targets only IL-23. IL-23 drives differentiation and maintenance of Th17 cells, which produce IL-17A, IL-17F, and IL-22 — key effector cytokines in psoriasis, PsA, and IBD. Selective IL-23 blockade reduces these downstream inflammatory signals while preserving IL-12-dependent Th1 responses important for antimycobacterial and antifungal immunity.
Pharmacokinetics
Absorption
SC bioavailability approximately 89% for the 150 mg dose. Peak concentration reached at approximately 3–14 days after SC injection.
Half-Life
Approximately 28 days.
Metabolism
Standard proteolytic catabolism; not metabolized by hepatic CYP450.
Excretion
Protein catabolism; no significant renal or biliary excretion of intact antibody.
Pregnancy & Breastfeeding Safety
No adequate human data. Animal studies showed no harm at high doses. Use only if clearly needed.
FDA Pregnancy Category No adequate human data. Animal studies showed no harm at high doses. Use only if clearly needed.
Consult your healthcare provider.
Full Pregnancy InformationBreastfeeding
Many medications pass into breast milk in varying amounts. Before using Risankizumabwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Refrigerate at 36°F–46°F (2°C–8°C). Protect from light. Do not freeze or shake. Allow to warm to room temperature for 15–30 minutes before SC injection.
Frequently Asked Questions
1
How does risankizumab differ from ustekinumab?
Both target the IL-23 pathway, but ustekinumab blocks the shared p40 subunit of both IL-12 and IL-23, while risankizumab selectively blocks only the p19 subunit of IL-23. This selective IL-23 inhibition with risankizumab preserves IL-12-mediated Th1 responses while more completely suppressing IL-17/IL-22 inflammatory pathways. In head-to-head trials in psoriasis (IMMerge), risankizumab demonstrated superior PASI 90 responses compared with ustekinumab. For Crohn's disease, risankizumab is approved for induction and maintenance, with an IV induction phase followed by SC maintenance — a unique dosing approach in IBD biologics.
2
Can risankizumab be used for both skin psoriasis and IBD at the same time?
Yes, risankizumab is approved for both plaque psoriasis and inflammatory bowel disease (Crohn's disease and ulcerative colitis). In patients with concomitant psoriasis and IBD — a common co-occurrence in spondyloarthritis-associated conditions — risankizumab can theoretically address both conditions, making it an attractive option over IL-17 inhibitors (which can exacerbate IBD) or selective GI biologics. However, dosing regimens differ by indication, so consultation with both a dermatologist/rheumatologist and gastroenterologist is recommended.
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Comprehensive Guide to Risankizumab
Risankizumab (Skyrizi) is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of interleukin-23 (IL-23), blocking the IL-23/Th17 axis without affecting IL-12 signaling. Approved by the FDA in April 2019 for moderate-to-severe plaque psoriasis, it has since received approvals for psoriatic arthritis (2022), moderately to severely active Crohn's disease (2022), and ulcerative colitis (2023). Its selective IL-23 blockade provides potent anti-inflammatory effects in psoriatic disease and IBD while theoretically preserving aspects of innate immunity that IL-12 supports. In the IMMhance and IMMvent psoriasis trials, risankizumab demonstrated PASI 90 response rates of 72–75% at 16 weeks, and in the ADVANCE/MOTIVATE Crohn's trials achieved clinical remission in approximately 45% of patients at 12 weeks of IV induction. The once-every-12-week SC dosing in psoriasis and PsA offers a low injection burden, making it highly convenient for long-term management.
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Risankizumab
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.