KESIMPTA® has a demonstrated safety and tolerability profile across pooled ASCLEPIOS I and II studies1,9
Treatment Discontinuations:
- Treatment discontinuation rates due to adverse events were similar between KESIMPTA® (5.7%) and teriflunomide (5.2%)¹
- The decrease in mean levels of IgM in patients treated with KESIMPTA® was not associated with increased risk of infection14
LLN=lower limit of normal. A full list of adverse events is available in the Summary of Product Characteristics.
The incidence of injection-related reactions was highest with the first injection, decreasing significantly with subsequent injections.
† During the studies, treatment was interrupted if IgM levels of patients dropped 10% below the LLN or if IgG levels dropped 20% below the LLN.9
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▼ This medicinal product is subject to additional monitoring. Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: [email protected] or by calling 01 2080 612.
Reporting of side effects
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance, website www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.
