Risankizumab
Risankizumab is a monoclonal antibody medication used to treat autoimmune conditions, particularly inflammatory skin and joint disorders. It works by specifically targeting and blocking the IL-23 cytokine, which plays a key role in driving inflammatory responses in the body. This medication is primarily prescribed for adults with moderate to severe plaque psoriasis and psoriatic arthritis.
Risankizumab is an immunosuppressant monoclonal antibody that treats autoimmune conditions like psoriasis by blocking the IL-23 inflammatory pathway.
Key facts at a glance
- ATC
- L04AC18
- RxNorm
- 2166040
- Generic
- Risankizumab
- Class
- atc-l04
- Brands
- Skyrizi
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits significantly outweigh risks; advise women of reproductive potential to use effective contraception during treatment and for at least 4 months after last dose
regular prenatal monitoring; assess risk-benefit in each case
pregnancy
second third trimesteravoid
IgG antibodies cross placenta in increasing amounts during second and third trimesters; discontinue therapy at least 4 months before planned pregnancy if possible
close fetal monitoring; assess neonatal immune function
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot recommended
discontinue breastfeeding during treatment and for at least 4 months after last dose; decision to stop breastfeeding or discontinue therapy should consider benefit of breastfeeding for infant and benefit of therapy for mother
monitor infant for infections
geriatric
elderly 65 years and olderno adjustment needed
no dose adjustment required; monitor for infections; limited clinical experience in patients 65 years and older
routine monitoring for infections and adverse reactions
Use with caution and monitor for adverse effects.
pediatric_age
children adolescents under 18not recommended
not approved for use in patients under 18 years of age; safety and efficacy not established in pediatric population
not applicable - not indicated for pediatric use
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
any renal impairmentno adjustment needed
no dose adjustment required for patients with any degree of renal impairment; risankizumab is a monoclonal antibody and not renally excreted
standard monitoring
hepatic_impairment
any hepatic impairmentno adjustment needed
no dose adjustment required for patients with hepatic impairment
standard monitoring
alcohol_users
moderate heavy alcohol useno specific adjustment
no specific dose adjustment recommended; however, avoid alcohol as it may exacerbate underlying inflammatory conditions
standard monitoring for treatment response
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Biologic monoclonal antibody targeting interleukin-23
Mechanism of action
Selective binding to IL-23 cytokine preventing receptor interaction
FDA approval year
Initial FDA approval for plaque psoriasis
Approved indications
Therapeutic indications approved by FDA
Risankizumab is primarily used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is also approved for treating psoriatic arthritis, either alone or in combination with methotrexate. Additional indications include moderate to severe Crohn's disease and ulcerative colitis.
Risankizumab is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of the IL-23 cytokine. By blocking IL-23, it prevents the cytokine from interacting with its receptor on immune cells, thereby reducing the inflammatory cascade that contributes to autoimmune symptoms.
Risankizumab is administered as a subcutaneous injection, typically with loading doses followed by maintenance doses every 12 weeks. As an immunosuppressant, it may increase the risk of infections, including serious infections and reactivation of tuberculosis. Patients should be screened for tuberculosis and hepatitis B before starting treatment. Common side effects include upper respiratory infections, headache, and fatigue. The medication should not be used with live vaccines.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy