Description
Indication & Scope
HYFTOR® Sirolimus Gel serves as topical treatment of facial angiofibromas associated with tuberous sclerosis complex in patients aged 6 years and older.
- Mechanism: Topical mTOR inhibition suppresses abnormal cell proliferation and vascular hyperplasia of facial skin lesions, gradually fading angiofibroma hyperplastic tissues.
- Drug class: Topical mTOR inhibitor, dermatological targeted therapeutic agent.
- Clinical use: Specialized topical treatment for facial angiofibroma secondary to tuberous sclerosis complex in pediatric and adult patients.
| Generic Name | Sirolimus Gel |
| Brand Name | HYFTOR® |
| Ingredient | Sirolimus |
| Dosage Form | Gel |
| Package | 0.2% (10g : 20mg)*1 tube/box |
| Conditions Treated | Facial angiofibromas caused by tuberous sclerosis complex (patients ≥6 years old) |
| Taboos | Contraindicated in sirolimus or gel excipient hypersensitivity; prohibited for children under 6 years of age |
| Place of origin | 2-5-4, Tsurumi, Tsurumi-ku, Osaka, Osaka538-0053, Japan |
| Prescription type | Prescription-only |
| Storage Conditions | Store at 15°C–30°C, sealed storage, avoid freezing and high temperature exposure |
| Manufacturer | Joto Plant, TOYO Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | HJ20233148 |
| Approval Date | Apr 29, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Thin layer topical application on lesion skin areas once daily.
Time: Fixed daily topical application before bedtime.
Instructions for use: Apply thin uniform layer only on angiofibroma lesions; avoid contact with normal skin, eyes and oral mucosa; do not cover with dressing after application.
Interaction: No significant topical drug interaction with conventional dermatological preparations; avoid combined irritating topical agents.
Side effects: Local mild reactions include skin dryness, erythema, itching and peeling; rare local allergic inflammation and skin irritation.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What skin lesion does Sirolimus Gel specifically treat?
The gel treats facial angiofibromas induced by tuberous sclerosis complex for patients aged 6 years and above.
What is the standard application frequency of Sirolimus Gel?
The standard administration frequency is once-daily thin-layer topical application on lesion areas.
What age group is prohibited from using Sirolimus Gel?
Children under 6 years of age are prohibited from medication application.
What skin parts need avoidance during Sirolimus Gel application?
Normal facial skin, eye mucosa and oral mucosa need complete avoidance during application.
HYFTOR® | Sirolimus Gel | Facial Vascular Fibroadenoma | DengYueRX
INN: Sirolimus Gel
Indications: Facial vascular fibroadenoma
Dosage Form: Gel
Strength: 0.2% (10g : 20mg)/tube
Original price was: $450.76.$383.14Current price is: $383.14.
