Risankizumab
Generic Name: Risankizumab-rzaa
Brand Names: Skyrizi
Risankizumab is an IL-23 blocker for psoriasis, psoriatic arthritis, and Crohn's disease.
Drug Class
Interleukin-23 (IL-23) Inhibitor
Pregnancy
Not recommended during pregnancy; insufficient human data. Animal studies did not show fetal harm, but use only if clearly needed.
Available Forms
Subcutaneous Injection
What It's Used For
Dosage Quick Reference
These are general dosage guidelines. Your doctor will determine the appropriate dose for your specific situation.
| Condition | Starting Dose | Maintenance Dose |
|---|---|---|
| Plaque Psoriasis | 150 mg at weeks 0 and 4 | 150 mg every 12 weeks |
| Psoriatic Arthritis | 150 mg at weeks 0 and 4 | 150 mg every 12 weeks |
| Crohn's Disease (Induction) | 600 mg IV at weeks 0, 4, and 8 | Transition to 360 mg SC every 8 weeks |
| Ulcerative Colitis (Induction) | 1200 mg IV at weeks 0, 4, and 8 | Transition to 180 mg or 360 mg SC every 8 weeks |
Side Effects
Common Side Effects:
- Upper respiratory infections
- Headache
- Fatigue
- Injection site reactions
- Tinea infections
Serious Side Effects:
- Serious infections
- Hypersensitivity reactions
- Hepatotoxicity (during IV induction for Crohn's)
Drug Interactions
Major Interactions:
- Live vaccines — Avoid live vaccines during treatment due to immunosuppressive effects; complete all age-appropriate vaccinations prior to starting therapy
- CYP450 substrates with narrow therapeutic index (e.g., warfarin, cyclosporine, theophylline) — IL-23 inhibition may normalize CYP450 activity previously suppressed by chronic inflammation, potentially altering drug levels; monitor closely when initiating or discontinuing risankizumab
- Other immunosuppressants — Concurrent use with other biologic immunosuppressants has not been studied and may increase infection risk; avoid combination biologic therapy
Additional Information
Risankizumab is a humanized monoclonal antibody that selectively blocks interleukin-23 (IL-23) by binding to its p19 subunit. It is used to treat moderate-to-severe plaque psoriasis, psoriatic arthritis, and Crohn's disease.
Mechanism of Action
Risankizumab targets the IL-23 pathway:
- IL-23 p19 subunit binding: Selectively binds to the p19 subunit of IL-23
- Blocks IL-23 signaling: Prevents IL-23 from binding to its receptor
- Reduces Th17 cell activity: IL-23 is critical for survival and function of Th17 cells
- Decreases inflammatory cytokines: Reduces IL-17, IL-22, and other downstream mediators
IL-23 is a key driver of inflammation in psoriasis, psoriatic arthritis, and inflammatory bowel disease.
Available Formulations
- Prefilled syringe: 75 mg/0.83 mL (for psoriasis)
- Prefilled pen: 150 mg/mL (for psoriasis)
- IV solution: 600 mg/10 mL (for Crohn's disease induction)
Medical Uses
FDA-Approved Indications:
- Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
- Active psoriatic arthritis in adults
- Moderately to severely active Crohn's disease in adults
Dosing Guidelines
Plaque Psoriasis:
- 150 mg subcutaneously at weeks 0 and 4, then every 12 weeks
Psoriatic Arthritis:
- 150 mg subcutaneously at weeks 0 and 4, then every 12 weeks
- May be used alone or with non-biologic DMARDs
Crohn's Disease:
- Induction: 600 mg IV at weeks 0, 4, and 8
- Maintenance: 360 mg subcutaneously at week 12 and every 8 weeks thereafter
Important Safety Information
Contraindications:
- History of serious hypersensitivity reaction to risankizumab
Warnings and Precautions:
- Infections: Increased risk of infections; evaluate for tuberculosis before initiating
- Tuberculosis: Test for latent TB; treat before starting if positive
- Hepatotoxicity (Crohn's disease): Monitor liver enzymes during IV induction
- Immunizations: Complete all age-appropriate vaccinations before starting; avoid live vaccines during treatment
Drug Interactions
No formal drug interaction studies have been conducted. As a monoclonal antibody, risankizumab is not expected to interact via cytochrome P450 pathways.
Considerations:
- Live vaccines: Avoid during treatment
- CYP450 substrates: Formation of IL-23 inhibitor-induced CYP enzymes may normalize; monitor narrow therapeutic index drugs
Special Populations
- Hepatic Impairment: Not formally studied; monitor liver enzymes during Crohn's disease induction
- Renal Impairment: Not expected to affect pharmacokinetics
- Pregnancy: Limited data; use only if benefit outweighs risk
- Lactation: Unknown if excreted in milk; consider risk vs benefit
- Elderly: No dose adjustment
- Pediatric: Not approved for patients <18 years
Frequently Asked Questions
Questions to Ask Your Doctor
Consider discussing these topics at your next appointment:
- ✓Ask your doctor whether you need a tuberculosis test before starting risankizumab.
- ✓Discuss whether any of your current vaccines need to be updated before beginning treatment.
- ✓Ask how to recognize early signs of infection and when to seek medical attention.
- ✓Discuss whether risankizumab is appropriate if you have a history of recurrent infections or liver disease.
- ✓Ask about the long-term safety profile and how often you will need follow-up appointments.
Related Health Conditions
This medication is commonly used to treat or manage the following conditions:
Medical Disclaimer: This information is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting, stopping, or changing any medication. Your doctor can provide personalized recommendations based on your specific health condition and medical history.
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Questions About This Medication?
Talk to your doctor or pharmacist about whether Risankizumab is right for you.
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