Although delgocitinib cream has no absolute contraindications, it should be used with caution or avoided in specific situations. Understanding which populations are not suitable or require dose adjustment is an important step in ensuring treatment safety.

I. Contraindications and situations to avoid

1. Active severe infection

(1) This product may mildly suppress the immune system, potentially worsening existing infections or reducing the ability to fight infections.

(2) During active, severe infections (e.g., sepsis, severe pneumonia, active tuberculosis, etc.), use should be suspended until the infection is fully controlled, after which resumption of treatment may be considered.

2. Allergy to any ingredient of this product

(1) Although no absolute contraindication is listed in the prescribing information, patients allergic to the active ingredient (delgocitinib) or any excipients (such as benzyl alcohol, cetearyl alcohol, etc.) should not use this product.

(2) If severe rash, edema, or dyspnea occurs after application, discontinue use immediately and seek medical attention.

3. Avoid concomitant use with similar drugs

Concomitant use of this product with other JAK inhibitors (oral or topical) or potent immunosuppressants (such as cyclosporine, methotrexate) is not recommended, as it may lead to excessive immunosuppression and increase the risk of infections and other serious adverse reactions.

II. Special physiological populations

1. Pregnancy

(1) Adequate human studies on topical delgocitinib during pregnancy are currently lacking, and safety has not been established.

(2) It is recommended that use during pregnancy only occur when clearly needed and when the physician judges that the benefit outweighs the risk.

2. Lactation

To minimize infant exposure, breastfeeding women should avoid direct contact of the treated skin areas (especially hands and wrists) with the infant after application, and avoid applying the ointment directly to the nipple area.

3. Children

The safety and efficacy of this product in pediatric patients have not been established, and use is not recommended in children and adolescents under 18 years of age.

4. Elderly (aged 65 years and older)

(1) Clinical trials showed no overall differences in safety and efficacy between elderly and younger adult patients, and no special dose adjustment is required.

(2) However, because elderly patients may have more comorbidities, close monitoring is still recommended during treatment.

III. Patients with underlying diseases

1. Chronic or recurrent infections

(1) In patients with chronic infections (e.g., recurrent skin infections, chronic urinary tract infections) or a history of recurrent episodes, the infection control status should be assessed before use.

(2) If new infections occur during treatment, they should be managed promptly.

2. Tuberculosis exposure or history of tuberculosis

(1) Patients with a history of tuberculosis or close contact with active tuberculosis patients should undergo tuberculosis screening before use.

(2) If latent tuberculosis is present, anti-tuberculosis treatment should be initiated under medical guidance before reassessing whether the drug can be used.

3. Viral hepatitis (hepatitis B / hepatitis C)

(1) Use of this product is not recommended in patients with active hepatitis B or hepatitis C, as it may increase the risk of viral reactivation.

(2) Patients with a history of hepatitis should undergo virological screening before treatment, and liver function and viral load should be monitored according to clinical guidelines during treatment.

4. Patients with diabetes and dyslipidemia

(1) Hypoglycemia and elevated lipids have been reported with oral JAK inhibitors.

(2) Although systemic exposure from the topical formulation is low, patients with diabetes and those with pre-existing dyslipidemia should still monitor blood glucose and lipid levels during treatment.