Delgocitinib Topical

Delgocitinib Topical is a prescription medication 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 Topical is available under the following different brand names: Anzupgo

Common side effects of Delgocitinib Topical include:

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

Serious side effects of Delgocitinib Topical include:

• increased risk of serious infections, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses
• increased risk of certain non-melanoma skin cancers
• potential risks from Janus kinase (JAK)  inhibition

Rare side effects of Delgocitinib Topical include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Topical cream

• 2% (20 mg/g)

Eczema

Adult dosage

• Apply a thin layer Topically twice daily to affected areas on hands and wrists
• Not to exceed 30 g/2 weeks (60 g/month)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Delgocitinib Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Delgocitinib Topical?”

Cautions

• Serious infections
  • May increase the risk of infections; avoid use with an active or serious infection
  • Bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens reported with oral or Topical JAK inhibitors; some cases were serious or fatal
  • Closely monitor for infection during and after treatment
  • Promptly initiate complete diagnostic testing if a new infection develops during treatment; start appropriate antimicrobial therapy and monitor
  • Interrupt Delgocitinib treatment if a serious infection develops; do not resume treatment until infection resolves or is adequately treated
  • Consider treatment risks and benefits before initiating treatment in patients
• With chronic or recurrent infection
  • Those who have been exposed to tuberculosis
  • With a history of serious or opportunistic infections
  • With underlying conditions that may predispose them to infection
• Viral reactivation
  • Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical trials
  • If a patient develops herpes zoster, consider interrupting Delgocitinib treatment until the infection resolves
  • The impact of Delgocitinib on chronic viral hepatitis reactivation is unknown
  • Patients with active hepatitis B or C infections were excluded from clinical trials; it is not recommended for use with active hepatitis B or C
  • Consider viral hepatitis screening and monitoring for reactivation by clinical guidelines before starting therapy and during therapy
  • If signs of reactivation occur, consult a hepatitis specialist
• Non-melanoma skin cancers
  • Non-melanoma skin cancers (e.g., basal cell carcinoma) reported
  • Periodic examination of skin at application sites is recommended for all patients, particularly those with risk factors for skin cancer
  • Advise patients to avoid sunlamps and minimize exposure to sunlight by wearing sun-protective clothing or using broad-spectrum sunscreen
• Immunizations
  • Before initiating treatment, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including herpes zoster vaccinations
  • Avoid vaccination with live vaccines immediately before, during, and immediately after treatment
• Potential risks related to JAK inhibition
  • Unknown if delgocitinib may be associated with observed or potential adverse reactions of JAK inhibition
  • In a large, randomized, postmarketing safety trial of an oral JAK inhibitor in combination with methotrexate in rheumatoid arthritis (RA), patients aged 50 years and older with at least 1 cardiovascular (CV) risk factor, higher rates of all-cause mortality, including sudden CV death, major adverse CV events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with JAK inhibitor compared with those treated with TNF blockers
• Not indicated for use in RA

Treatment with oral and Topical JAK inhibitors is associated with increases in lipid parameters (eg, total cholesterol, low-density lipoprotein cholesterol, triglycerides)

Pregnancy and Lactation

• Data during pregnancy are insufficient to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
• Data are not available regarding the presence of the drug in human milk, effects on breastfed infants, or effects on milk production
  • After oral administration, delgocitinib was present in the milk of lactating rats
  • Consider the developmental and health benefits of breastfeeding, along with the mother's clinical need for treatment and any potential adverse effects on breastfed infants from the drug or from the underlying maternal condition
• Clinical considerations
  • Advise breastfeeding women to avoid direct contact with the nipple and the surrounding area immediately after applying cream to hands and/or wrists to minimize potential infant exposure