Derm Finder | Anzupgo® (delgocitinib)

INDICATION

What is ANZUPGO?

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.

Please see full Prescribing Information and Medication Guide.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

ANZUPGO is for use on the skin only. Do not use in or on your eyes, mouth, or vagina.

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

ANZUPGO may increase your risk of infections because it contains delgocitinib, a type of medicine called Janus kinase (JAK) inhibitors that can affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Serious infections (including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses) have happened with JAK inhibitors. Some people have been hospitalized or died.
- Do not use ANZUPGO if you have an active, serious infection. Do not start ANZUPGO if you have any infection unless your healthcare provider says it’s okay.
- You may be more likely to get shingles (herpes zoster) or eczema herpeticum (painful, blistering rash) during treatment.
Before using ANZUPGO: Tell your healthcare provider if you:
- are being treated for an infection or have an infection that does not go away or that keeps coming back
- have TB or were in close contact with someone with TB
- have had shingles
- have had hepatitis B or C
- have symptoms of infection such as fever, chills, sweating, muscle aches, cough/shortness of breath, blood in phlegm, weight loss, warm/red/painful skin or sores, diarrhea or stomach pain, burning when urinating or urinating more often, or feeling very tired.
After starting ANZUPGO: Call your healthcare provider right away if you have signs of infection. Your provider may stop ANZUPGO until the infection is controlled.
ANZUPGO may increase the risk of certain skin cancers. Your healthcare provider will check your skin during treatment.
- Avoid sunlamps, limit sun, wear protective clothing, and use broad-spectrum sunscreen.
- Tell your healthcare provider if you have ever had any type of cancer.
It is not known if ANZUPGO has the same risks as other JAK inhibitors. Increased risk of death (all causes) happened in people 50+ with at least one heart disease risk factor taking a JAK inhibitor for rheumatoid arthritis (RA) compared with TNF blockers. ANZUPGO is not for use in RA. Oral or other topical JAK inhibitors have also caused increased cholesterol. Low blood sugar in diabetics has happened after taking JAK inhibitors by mouth.

Before using ANZUPGO, tell your healthcare provider if you:

have an infection
have recently received or are scheduled to receive a vaccine. Do 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 or plan to breastfeed (it is not known if ANZUPGO passes into breast milk). Avoid touching the nipple/area around it right after applying ANZUPGO to your hands and wrists.

The most common side effects were application site reactions, including pain, tingling, itching, and redness; bacterial skin infections, including finger cellulitis and nail infections; and 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.