Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate (see section 5.1).
Anzupgo should be initiated and supervised by physicians with experience in the diagnosis and treatment of chronic hand eczema.
A thin layer of Anzupgo should be applied twice daily to the affected skin of the hands and wrists until the skin is clear or almost clear (see section 5.1). 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.
If an application is missed, the cream should be applied as soon as possible. Thereafter, applications should be resumed at the regular scheduled time.
No dose adjustment is recommended for elderly patients.
No studies with Anzupgo have been performed in patients with severe hepatic or renal impairment. However, dose adjustment is not recommended due to the minimal systemic exposure of topically applied delgocitinib (see section 5.2).
The safety and efficacy of Anzupgo in children and adolescents below 18 years of age has not been established. No data are available.
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. Patients should avoid applying other topical products immediately before and after application of Anzupgo (see section 4.5). 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.
No systemic signs of overdose are expected following topical application of Anzupgo due to the minimal systemic absorption of delgocitinib. If too much cream has been applied, the excess can be wiped off.
3 years.
After first opening: 1 year.
Do not freeze.
Laminate tube with an aluminium barrier layer and an inner layer of low-density polyethylene fitted with a polypropylene flip-top cap.
Package sizes: 1 tube of 15 g or 60 g.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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