Anzupgo

Anzupgo should be initiated and supervised by physicians with experience in the diagnosis and treatment of chronic hand eczema. 1). It is recommended to apply the cream at regular intervals, approximately 12 hours apart. In the event of recurrence of the signs and symptoms of CHE (flares), twice daily treatment of the affected areas should be re-initiated as needed.

Treatment should be discontinued if no improvement is seen after 12 weeks of continuous treatment. Missed dose If an application is missed, the cream should be applied as soon as possible. Thereafter, applications should be resumed at the regular scheduled time.

3 Special populations Elderly patients No dose adjustment is recommended for elderly patients. Hepatic and renal impairment No studies with Anzupgo have been performed in patients with severe hepatic or renal impairment. 2). Paediatric population The safety and efficacy of Anzupgo in children and adolescents below 18 years of age has not been established.

No data are available. Method of administration Anzupgo is for cutaneous use only. A thin layer of Anzupgo should be applied to clean and dry skin of the affected areas of the hands and wrists. 5). Co-application with emollients within 2 hours before and after application of delgocitinib has not been studied.

If someone else applies the cream to the patient, they should be instructed to wash their hands after application. Contact with eyes, mouth, or other mucous membranes should be avoided. If contact with mucous membranes occurs, rinse thoroughly with water.

0%). 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).

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.

11 events per 100 patient years of observation). 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.

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. g. contact dermatitis), or irritation to the eyes and mucous membranes.

g. contact dermatitis).

1.