Delgocitinib

ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. ANZUPGO is a Janus kinase (JAK) inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.

Delgocitinib, a Janus kinase (JAK) inhibitor, inhibits the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). JAK signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, and activation and subsequent localization of STATs to the nucleus, leading to the expression of cytokine-responsive genes to induce specific biological responses in target cells. The exact mechanism of action of delgocitinib in the treatment of moderate to severe CHE is currently not known.

See the full prescribing information for recommended immunizations prior to treatment. Do not use more than 30 grams per 2 weeks or 60 grams per month. Apply twice daily to skin of the affected areas only on the hands and wrists. For topical use only. Not for oral, ophthalmic, or intravaginal use.

None None.

Serious Infections: ANZUPGO may increase the risk of infection. Eczema herpeticum was observed in a subject treated topically with ANZUPGO. Avoid use of ANZUPGO in patients with an active or serious infection. If a serious infection develops, discontinue ANZUPGO until the infection resolves. Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. Immunizations: Avoid vaccination with live vaccines immediately prior to, during, and immediately after ANZUPGO treatment. Potential Risks Related to JAK Inhibition: It is not known whether ANZUPGO may be associated with the observed or potential adverse reactions of JAK inhibition.

Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia.

Store ANZUPGO at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted from 15°C to 30°C (59°F to 86°F). Do not freeze.