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Anzupgo (Delgocitinib): Uses, Side Effects and Dosage

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Prescription (Rx)
Strength:
20 mg/g
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Anzupgo

What is the most important information I should know about ANZUPGO?

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.

    • ANZUPGO should not be used in people with an active, serious infection. You should not start using ANZUPGO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) or eczema herpeticum (a blistery, painful skin rash) during treatment with ANZUPGO.

    Before starting ANZUPGO, tell your healthcare provider if you:

    • are being treated for an infection
    • have an infection that does not go away or that keeps coming back
    • have TB or have been in close contact with someone with TB
    • have had shingles (herpes zoster)
    • have had hepatitis B or C
    • think you have an infection or have symptoms of an infection such as:
  • fever, sweating, or chills
  • muscle aches
  • cough or shortness of breath
  • blood in your phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or
  • urinating more often than usual
  • feeling very tired

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.

    • Avoid sunlamps and limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun or use a broad-spectrum sunscreen.
    • Tell your healthcare provider if you have ever had any type of cancer.
  • Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking other oral or topical JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least 1 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. Other oral or topical JAK inhibitors have also caused increased cholesterol. Low blood sugar in people with diabetes has happened after taking JAK inhibitors by mouth.

See "What are the possible side effects of ANZUPGO?" for more information about side effects.

What is ANZUPGO?

ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema 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.

It is not known if ANZUPGO is safe and effective in children.

Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you:

  • See "What is the most important information I should know about ANZUPGO?"
  • have an infection
  • have recently received or are scheduled to receive a vaccine. People who use ANZUPGO should not receive live vaccines right before starting, during treatment, or right after treatment with ANZUPGO.

  • are pregnant or plan to become pregnant. It is not known if ANZUPGO will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if ANZUPGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ANZUPGO. If you use ANZUPGO while breastfeeding, avoid touching the nipple and surrounding area right away after applying ANZUPGO to your hands and wrists.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ANZUPGO?

  • ANZUPGO is for use on the skin of your hands and wrists only. Do not use ANZUPGO in or on your eyes, mouth, vagina or other mucous membranes. If contact with mucous membranes happens, rinse well with water.
  • Use ANZUPGO exactly as your healthcare provider tells you to use it.
  • Clean and dry skin of the affected areas before applying ANZUPGO.
  • Apply a thin layer of ANZUPGO 2 times each day to affected areas on your hands and wrists. Do not use more than 30 grams in 2 weeks or 60 grams in a month.
  • If someone else applies ANZUPGO for you, they should wash their hands after applying ANZUPGO.

What are the possible side effects of ANZUPGO?

ANZUPGO may cause serious side effects, including:

  • See "What is the most important information I should know about ANZUPGO?"

The most common side effects of ANZUPGO include:

  • application site reactions, including pain, tingling, itching, and redness
  • bacterial skin infections, including finger cellulitis, and nail infections
  • low white blood cells

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.

How should I store ANZUPGO?

  • Store ANZUPGO at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze ANZUPGO.

Keep ANZUPGO and all medicines out of the reach of children.

General information about the safe and effective use of ANZUPGO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ANZUPGO for a condition for which it was not prescribed. Do not give ANZUPGO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ANZUPGO that is written for health professionals.

What are the ingredients in ANZUPGO?

Active ingredient: delgocitinib

Inactive ingredients: benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.

Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12, Ireland

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

ANZUPGO® is a registered trademark of LEO Pharma A/S.

© 2026 LEO Pharma Inc. All rights reserved.

For more information about ANZUPGO, go to www.ANZUPGO.com or call 1-877-494-4536.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 219155 · View the label on DailyMed

Revision date stated in the text: June 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Anzupgo

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Janus Kinase Inhibitor
Active ingredient Delgocitinib 20 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) LEO PHARMA AS
FDA approval NDA 219155New Drug Application (NDA) Approved July 23, 2025
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
20 mg/g – 15 g in 1 tube / 1 in 1 carton NDC 50222-280-91
20 mg/g – 30 g in 1 tube / 1 in 1 carton NDC 50222-280-30
20 mg/g – 5 g in 1 tube / 1 in 1 carton NDC 50222-280-99

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.