迪高替尼软膏(Delgocitinib)的中文说明书

Delgocitinib ointment, also known as Corectim and Delgocitinib, is a Janus kinase (JAK) inhibitor.

1. Indications

1. It is suitable for the topical treatment of moderate to severe chronic hand eczema in adults who have insufficient response to topical corticosteroids or where the use of topical corticosteroids is not recommended.

2. It is not recommended to use digotinib ointment in combination with other JAK inhibitors or powerful immunosuppressants.

2. Usage and Dosage

1. Adult dosage

Twice a day, apply only to the affected skin of hands and wrists. Use no more than 30 grams every 2 weeks, or 60 grams per month.

2. Usage

(1) For local skin use only. Not for oral, ophthalmic, or vaginal use.

(2) Before starting treatment, please refer to the complete prescription information and complete all age-appropriate vaccinations.

3. Dosage forms and specifications

Cream, each gram of Delgocitinib ointment contains 20 mg of Delgocitinib.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

4. Contraindications

None.

V. Warnings and Precautions

1. Serious infection

(1) This product may increase the risk of infection. In clinical trials, patients have experienced eczema and herpes.

(2) Avoid use in patients with active or severe infections. Patients need to be closely monitored for signs of infection during and after treatment. If serious infection occurs, treatment should be interrupted until the infection is controlled.

2. Viral reactivation

(1) Viral reactivation (such as herpes zoster) has been reported in clinical trials. If shingles occurs, discontinuation of treatment should be considered until recovery occurs.

(2) Patients with active hepatitis B or C are not recommended to use this product. Viral hepatitis screening and monitoring according to clinical guidelines should be considered before treatment.

3. Non-melanoma skin cancer

(1) Non-melanoma skin cancer such as basal cell carcinoma has been reported in patients treated with this product.

(2) It is recommended to conduct regular skin examinations on the medication site, especially for patients with skin cancer risk factors.

(3) It is recommended that patients avoid using sunlamps and reduce sun exposure by wearing sun-protective clothing or using broad-spectrum sunscreen.

4. Immunizations

Before starting treatment with this product, all age-appropriate vaccinations, including herpes zoster vaccine, should be completed in accordance with current immunization guidelines. Avoid using live vaccines before, after and during treatment.

5. Potential risks of JAK inhibitors

(1) Oral JAK inhibitors have been observed to increase the risk of all-cause mortality, major adverse cardiovascular events, thrombosis and malignant tumors in patients with rheumatoid arthritis. This product is not suitable for rheumatoid arthritis.

(2) Oral and topical JAK inhibitor treatment is associated with an increase in blood lipid parameters (total cholesterol, low-density lipoprotein cholesterol and triglycerides).

VI. Medication for Special Populations

1. Pregnancy

Currently there is a lack of sufficient data on the use of this product by pregnant women to assess the related risks. Animal reproduction studies have not shown adverse effects on fetal development at doses much higher than human exposure.

2. Lactation period

(1) There is no data to show whether this product is secreted with human milk, and its impact on breast-fed infants or milk production.

(2) It is recommended that lactating women immediately avoid direct contact with the nipple and surrounding areas after applying this product to their hands and/or wrists to minimize infant exposure.

3. Pediatric use

The safety and effectiveness have not been established in pediatric patients.

4. Elderly use

Clinical research data show that no overall difference in safety and effectiveness was observed between elderly patients (≥65 years old) and young adult patients.

7. Side effects

In clinical practice, adverse reactions with an incidence rate of ≤1% include:

(1) Pain at the application site, abnormal sensation, itching, and erythema.

(2), bacterial skin infections (including digital cellulitis, paronychia), and other skin infections.

(3), leukopenia, neutropenia.

8. Drug Interactions

Please consult the product instructions for drug interaction information.

9. Mechanism of action

Digotinib ointment is a JAK inhibitor that can inhibit the activities of JAK1, JAK2, JAK3 and TYK2. The JAK/STAT pathway is involved in the signal transduction of multiple cytokines. The exact mechanism of action of this product in treating chronic hand eczema is currently unknown.