What is Skyrizi (risankizumab) for?
Skyrizi (risankizumab) is an interleukin-23 antagonist indicated to treat adults with:
- Plaque psoriasis that is moderate to severe in patients who are candidates for systemic therapy or phototherapy.
- Active psoriatic arthritis
It is available prefilled syringe and pen containing 150 mg/mL of risankizumab.
How does Skyrizi (risankizumab) work?
The active ingredient in Skyrizi, risankizumab, is a human monoclonal antibody, a type of protein, that binds to the cytokines interleukin (IL)-23. Cytokines play a role in signaling in a cell, especially in inflammation. Dysregulated production of and IL-23 were found to be very important in the development of specific diseases, such as psoriasis.
By binding to IL-23, tildrakizumab will block their action, and thereby slow down inflammation.
Where has Skyrizi (risankizumab) been approved?
Skyrizi (risankizumab) was approved by:
- The Food and Drug Administration (FDA), USA
- On April 23, 2019 to treat moderate to severe plaque psoriasis.
- On January 21, 2022 to treat active psoriatic arthritis.
- The European Medicines Agency (EMA)
- On April 26, 2019 to treat moderate to severe plaque psoriasis.
- On November 22, 2021 to treat active psoriatic arthritis.
- Therapeutic Goods Administration (TGA)
- On July 23, 2019 to treat moderate to severe plaque psoriasis.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team. /contact-us
How is Skyrizi (risankizumab) taken?
The standard dosage is:
- The first two doses of 150 mg are given 4 weeks apart
- The following doses are given every 12 weeks
Skyrizi is administered as an injection beneath the skin (subcutaneous).
Skyrizi can be taken in a treatment center or at home after you receive training from your doctor.
Complete information about Skyrizi (risankizumab) dosage (modification) and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Skyrizi (risankizumab)?
Common adverse reactions
The most common side effects (≥1% of patients) listed in the prescribing information include:
- Upper respiratory infections
- Headache
- Fatigue
- Injection site reactions
- Tinea infections
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Hypersensitivity reaction
- Infections
- Tuberculosis (TB)
Use in a specific population
Skyrizi (risankizumab) may harm your unborn baby when administered to a pregnant woman. Skyrizi may affect fertility in females and males who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
1. Full prescribing information [FDA]: Skyrizi (risankizumab) [PDF]
Novartis, Apr 2019
2. Targeting IL-23 in psoriasis: current perspectives
Fotiadou C, Psoriasis (Auckl.), Jan 4, 2018
3. AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
FDA press release, Apr 2019
4. U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis
FDA press release, Jan 2022
5. European Commission Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis
EMA press release, Apr 2019
6. AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis
EMA press release, Nov 2021
7. AbbVie welcomes Therapeutic Goods Administration (TGA) – Regulatory Approval of SKYRIZI™ (risankizumab) [PDF]
TGA press release, Jul 2019
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