ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema (CHE) in adults who are not well-controlled with or cannot use topical corticosteroids.
The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended.
ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth, or vagina.
ANZUPGO may cause serious side effects, including:
Serious Infections. ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections.
Before starting ANZUPGO, tell your healthcare provider if you:
After starting ANZUPGO, call your healthcare provider right away if you have any symptoms of an infection. ANZUPGO can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with ANZUPGO until your infection is controlled.
Non-melanoma skin cancer. ANZUPGO may increase your risk of certain non-melanoma skin cancers. Your healthcare provider will regularly check your skin during your treatment with ANZUPGO.
Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking oral or other topical JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least one heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. ANZUPGO is not for use in people with RA. Oral or other topical JAK inhibitors have also caused increased cholesterol.
Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
These are not all of the possible side effects of ANZUPGO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.