Anzupgo

HOS-100558 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The most common adverse reactions were application site reactions (1.0%). 4 Tabulated list of adverse reactions Table 1 lists the adverse reactions that were observed in clinical studies. The adverse reactions are presented by MedDRA system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000). Table 1 Adverse reactions System Organ Class Frequency Adverse reaction General disorders and Common Application site reactions* administration site conditions *see Description of selected adverse reactions Description of selected adverse reactions Application site reactions In the pool of three vehicle-controlled clinical studies through 16 weeks, 9 application site reactions (including application site pain, application site paraesthesia, application site pruritus, and application site erythema) were reported in 1.0% of patients treated with delgocitinib cream. 8 application site reactions were mild in severity and 1 was moderate. 7 of 9 occurred within the first week of treatment. No application site reactions resulted in treatment interruption, and the median time to resolution was 3 days. The event rate of application site reactions in the long-term extension study (0.56 events per 100 patient years of observation) was lower than in the 16-week vehicle-controlled clinical studies (4.11 events per 100 patient years of observation). Paediatric population The safety of delgocitinib cream was assessed in 98 adolescents (12 to 17 years; n=74 delgocitinib cream, n=24 vehicle cream) with moderate-to-severe CHE in a 16-week vehicle-controlled clinical study (DELTA TEEN). The safety profile in adolescents was similar to that of adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

HOS-100554 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100553 · has-indication-information · PDF-Seite 2

Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults and adolescents 12 years and older for whom topical corticosteroids are inadequate or inappropriate (see section 5.1).

HOS-100556 · has-interaction-information · PDF-Seite 4

No clinical interaction studies have been performed with topically or systemically administered delgocitinib (see section 5.2 for in vitro interaction studies). Given the limited metabolism of delgocitinib, application to a limited body surface area (hands and wrists), and minimal systemic exposure of topically applied delgocitinib, there is a low potential for interaction with systemic treatments. Delgocitinib has not been evaluated in combination with other topical medicinal products and co- application on the same skin area is not recommended.

HOS-100557 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no or a limited amount of data (less than 300 pregnancy outcomes) from the use of delgocitinib in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Anzupgo during pregnancy. Breast-feeding No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to delgocitinib is negligible (see section 5.3). Anzupgo can be used during breast-feeding. When Anzupgo is used during breast-feeding, care should be taken to avoid direct contact with the nipple or surrounding area after applying the cream to the hands and/or wrists. As a precautionary measure, care should be taken to avoid direct skin contact when taking care of an infant immediately after applying Anzupgo to the hands and/or wrists. Fertility No human data on the effect of delgocitinib on fertility are available. Based on findings in female rats, oral administration of delgocitinib resulted in reduced fertility at exposures considered sufficiently in excess of the human exposure (see section 5.3). Animal studies did not indicate effects with respect to fertility in males.

HOS-100555 · has-warning-information · PDF-Seite 3

Non-melanoma skin cancer Non-melanoma skin cancer (NMSC), predominantly basal cell carcinoma, has been reported in patients treated with topical JAK inhibitors. Periodic skin examination of the application site is recommended for all patients, particularly those with risk factors for skin cancer. Excipients with known effect Benzyl alcohol This medicinal product contains 10 mg benzyl alcohol (E 1519) in each gram of cream. Benzyl alcohol may cause allergic reactions or mild local irritation. Butylhydroxyanisole Butylhydroxyanisole (E 320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. Cetostearyl alcohol Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). 3