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Benvitimod
Benvitimod

Benvitimod(本维莫德乳膏)

Benvitimod Cream is the world's first approved aryl hydrocarbon receptor (AhR) modulator. It avoids the systemic side effects of oral medications and circumvents the risk of adverse reactions linked to traditional topical hormonal preparations.

  • 15g/tube

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Introduction of Benvitimod

Benvitimod Cream is a national Class 1 chemical innovative drug independently developed in China. It is the world's first approved aryl hydrocarbon receptor (AhR) modulator for the topical treatment of mild to moderate atopic dermatitis in children aged 2 years and above as well as adults, and is also approved for the topical treatment of mild to moderate stable plaque psoriasis in adults, with full independent intellectual property rights.

Indications

Benvitimod Cream is indicated for the topical treatment of mild to moderate atopic dermatitis in patients aged 2 years and above.

Overview

Generic Name
Benvitimod Cream,本维莫德乳膏
Brand Name
泽立美
Drug Type
Rx Drug,targeted drug
Approval No.
国药准字H20240040
Active Ingredient
Benvitimod
Dosage Form
15g/tube
Specification
Cream
Description
Benvitimod Cream is a white to off-white cream.
Expiry Date
24 months
Manufacturer
Shanghai Zedeman Pharmaceutical Technology Co., Ltd.;Shanghai Xinya Pharmaceutical Minhang Co., Ltd.
Storage
Protect from light, seal tightly and store below 30℃. Do not freeze.Keep out of reach of children.

Dosage and Administration

For topical use on the skin. Apply twice daily, once in the morning and once in the evening. Spread evenly over the affected areas to form a thin layer.

The affected skin must not be exposed to sunlight after application of this product. Protective measures against light exposure should also be taken even under natural light.

The safety and efficacy of continuous use of this product for more than 8 weeks have not been established. The maximum duration of clinical treatment shall not exceed 8 weeks.

This product must not be applied to the oral cavity, eyes, or vaginal area.

Contraindications

Contraindicated in patients with hypersensitivity to Benvitimod or any other ingredients in the cream.

Adverse Reactions

The common adverse reactions include folliculitis, contact dermatitis, pruritus at the application site, pain at the application site, and atopic dermatitis. Most of these reactions are transient, mild to moderate in severity, occur within 14 days after the start of medication, and most local cutaneous adverse reactions can resolve spontaneously without treatment.

Other adverse reactions involving other tissues, organs, or systemic reactions are rare. Observed adverse reactions include tinea corporis, furuncle, swelling at the application site, papules at the application site, abnormal hair growth, skin pain, miliaria, elevated alanine aminotransferase (ALT), elevated basophil count, increased eosinophil count, elevated white blood cell count, hyperuricemia, allergic rhinitis, and supraventricular extrasystoles.

No deaths occurred during the trial. One case (0.5%) of serious adverse reaction (allergic dermatitis) was reported during the trial.

Use in Special Populations

Use in Pregnant and Lactating Women

This product has not been tested in clinical trials involving pregnant or lactating women, and the safety of use has not been established. Pregnant women, women planning to become pregnant, and lactating women should use this product with caution.

Pediatric Use

Data from a randomized, double-blind, placebo-controlled confirmatory clinical trial (including 142 pediatric subjects aged 2–17 years) support the efficacy and safety of twice-daily topical application of Benvitimod Cream for the treatment of mild to moderate atopic dermatitis in children aged 2 years and above.

The efficacy and safety of Benvitimod Cream in children under 2 years of age have not been established.

Geriatric Use

Clinical studies of Benvitimod Cream did not include a sufficient number of subjects aged 65 years and above to determine whether there are differences in responses between these elderly patients and younger patients. If elderly patients need to receive treatment with this product, they should use it under the guidance of a specialist physician.

For more detailed drug information, please consult the official package leaflet.

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