Symbiox Benvitimod Cream

1. Indications and Usage
Plaque Psoriasis:
Indicated for the topical treatment of adults with mild-to-moderate stable plaque psoriasis suitable for topical therapy.
2. Dosage and Administration
Route of Administration:
Topical Use ONLY. Not for ophthalmic, oral, or intravaginal use.
Recommended Dosage:
Frequency: Apply locally twice daily (morning and evening) to the affected areas.
Application: Apply a thin layer evenly over the lesions.
Limits: Maximum daily dose should not exceed 6 g. The treatment area should not exceed 10% of the total body surface area (BSA).
Duration:
Clinical treatment duration should not exceed 12 weeks. The safety and efficacy of continuous use beyond 12 weeks have not been established.
Precautions:
Wash hands immediately after application. Do not apply to the face, perioral area, eyelids, groin, or anogenital regions.
3. Mechanism of Action
TAMA Activation:
Benvitimod is a non-steroidal Therapeutic Aryl Hydrocarbon Receptor Modulator (TAMA).
Immunomodulation:
It binds to and activates the Aryl Hydrocarbon Receptor (AhR), inhibiting the Th17 response and suppressing the synthesis and release of pro-inflammatory cytokines (e.g., IL-17, IL-22, TNF-α, IFN-γ).
Barrier Repair:
It induces apoptosis of activated T cells and keratinocytes, inhibits angiogenesis, and promotes the repair of skin barrier function.
4. Safety and Warnings
Photosensitivity:
Patients should avoid exposure to natural sunlight or artificial light after application. Sun avoidance measures should be adopted.
Contraindications:
Contraindicated in patients with hypersensitivity to the drug. Contraindicated in pregnant and breastfeeding women.
Restricted Areas:
Do not use on damaged skin, mucous membranes with ulcers, or skin folds (e.g., axilla, groin). Occlusive dressings are not recommended.
5. Adverse Reactions
Most Common:
Application site irritation (itching, burning, stinging, erythema). These reactions are usually transient, occurring within the first 2 weeks, and typically subside spontaneously without treatment.
Other Reactions:
Folliculitis, contact dermatitis, rash, skin dryness, and pain at the application site.
6. Drug Interactions
Unknown:
Drug interaction studies have not been conducted.
Concomitant Use:
It can be used in alternating or sequential therapy with topical corticosteroids or Vitamin D3 derivatives under medical guidance.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Benvitimod (1% w/w).
Storage:
Store in a tightly closed container, protected from light, at a temperature not exceeding 20°C. Keep out of reach of children.