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Safety and Side Effects of Skyrizi Treatment

Learn the safety profile of Skyrizi: IL-23 inhibition benefits, side effects, infection warnings, liver monitoring, and vaccination guidance for eligible adults.

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Safety and Side Effects of Skyrizi Treatment

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  1. Safety and Side Effects of Skyrizi Treatment Overview of Skyrizi as an IL-23 Inhibitor Skyrizi (risankizumab) is a humanized IgG1 monoclonal antibody that functions as a selective inhibitor of IL-23. It specifically targets the p19 subunit of interleukin-23 (IL-23), a key cytokine involved in the inflammatory pathways driving autoimmune diseases such as psoriasis (Ps) and psoriatic arthritis (PsA). By blocking IL-23 from binding to its receptor, Skyrizi disrupts the downstream release of proinflammatory cytokines, including IL-17A, IL-17F, and IL-22, which are central to disease progression. With a mean half-life of approximately28 days, Skyrizi provides durable suppression of the IL-23 pathway; however,the clinical significance of its pharmacokinetics remains under investigation.1,2 Approved Indications Skyrizi (risankizumab) is approved for the treatment ofmultiple inflammatory conditions. It is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults eligible for systemic therapy or phototherapy, and for active psoriatic arthritis (PsA) in adults. It is also approved for moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in adults. In Japan, Skyrizi has additional approvals for generalized pustular psoriasis (GPP), erythrodermic psoriasis (EP), and palmoplantar pustulosis (PPP). These indications highlight its role in targeting IL-23–driven inflammatory diseases.1,2 Common Side Effects from Clinical Studies Skyrizi (risankizumab) reported in clinical studies include nasopharyngitis (common cold), upper respiratory tract infections, joint pain (arthralgia), headache, and hypertension. These are generally mild to moderate in severity but should be monitored during treatment.3 Serious Adverse Effects and Warnings Serious allergic reactions may occur, presenting as fainting, dizziness, swelling of the face, lips, tongue, or throat, breathing difficulty, chest tightness, rash, hives, or severe itching. Infections: Skyrizi may lower immune defence and increase the risk of infections, including tuberculosis (TB). Symptoms include fever, cough, shortness of breath, blood in phlegm, weight loss, diarrhoea, painful urination, or skin infections. Liver problems (seen in Crohn’s disease/ulcerative colitis patients): May cause abnormal liver tests with rash, nausea, fatigue, jaundice, dark urine, or abdominal pain. Vaccinations: Skyrizi may impair vaccine response.

  2. Pregnancy and breastfeeding: Safety is not established; effective contraception is advised, and breastfeeding is not recommended. A pregnancy registry is available for exposed patients.4 Monitoring and Patient Considerations Hypersensitivity Reactions: •Skyrizi is contraindicated in patients with a history of serious allergic reactions to Skyrizi or its excipients; monitor for anaphylaxis. •If a serious hypersensitivity reaction occurs, discontinue Skyrizi and initiate appropriate therapy immediately. Infection Risk: •Skyrizi may increase the risk of infections. •Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. •If such an infection develops, monitor the patient closely and do not administer Skyrizi until the infection resolves. •Evaluate for TB infection before initiating treatment with SKYRIZI Liver Safety •Drug-induced liver injury has been reported in patients receiving Skyrizi for Crohn’s disease. •Monitoring is essential – check liver enzymes and bilirubin at baseline, during induction (12 weeks), and as part of routine follow-up. •Caution in cirrhosis – consider alternative therapies in patients with liver cirrhosis. •Interrupt Skyrizi if drug-induced liver injury is suspected, until ruled out. •Patient guidance – advise patients to seek immediate care if they develop symptoms of liver dysfunction (rash, jaundice, dark urine, abdominal pain, nausea, or fatigue). Vaccinations: •Avoid use of live vaccines in patients treated with Skyrizi. •Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. •Before initiating Skyrizi, complete ensure that all age-appropriate vaccinations have been completed according to current immunization immunisation guidelines.

  3. Patient Education: Educate patients on Skyrizi self-administration via the On-Body Injector and instruct them to promptly report any infections, liver issues, or allergic reactions.5 Conclusion Skyrizi (risankizumab) has emerged as an effective inhibitor of IL-23for several chronic inflammatory conditions, offering patients long-term disease control with convenient dosing. However, like all biologic therapies, it carries potential risks that require careful monitoring and patient education. Hypersensitivity reactions, infection risk, and drug-induced liver injury remain important safety considerations. Proactive screening for tuberculosis, regular monitoring of liver function monitoring, and review of vaccinationsare key steps before and during therapy. By combining clinical vigilance with patient awareness, healthcare professionals can optimize the benefits of Skyrizi while minimizing adverse effects, ensuring safer and more effective treatment outcomes. Note: This content is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified healthcare provider with any questions regarding a medical condition or treatment. Disclaimer: Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import. References 1.Full Prescribing Information For SKYRIZI [Internet]. fda.gov. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s029,761262s007 lbl.pdf 2.Pang Y, D’Cunha R, Winzenborg I, Veldman G, Pivorunas V, Wallace K. Risankizumab: Mechanism of action, clinical and translational science. Clinical and Translational Science [Internet]. 2024 Jan https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10777435/ 3.Shu Y, Chen J, Ding Y, Zhang Q. Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting 1;17(1). Available from:

  4. system. Frontiers in Immunology [Internet]. 2023 May 15 [cited 2024 Feb 14];14. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225532/ 4.Possible Side Effects | SKYRIZI® (risankizumab-rzaa) [Internet]. www.skyrizi.com. Available from: https://www.skyrizi.com/psoriasis-psoriatic-arthritis/about-skyrizi/side- effects-and-safety 5.SKYRIZI (risankizumab-rzaa) DOSING & MONITORING GUIDE [Internet]. 2024. Available from: https://www.skyrizihcp.com/content/dam/skyrizihcpivy/docs/ulcerative- colitis/uc-cd-dual-dosing-guide.pdf

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