Hyftor (Sirolimus Gel) 0.2% 10g | TSC Facial Angiofibroma | GLT

Generic Information: Hyftor (Sirolimus Topical Gel) — Nobelpharma Originator

Hyftor is the brand name of sirolimus topical gel 0.2%, developed by Nobelpharma of Japan and distributed in the United States by its subsidiary Nobelpharma America, LLC. This page covers the 0.2% gel supplied in a 10-gram tube, with each gram containing 2 mg of sirolimus. Hyftor is the first and only FDA-approved topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC), filling a long-standing gap for a highly visible and distressing manifestation of this rare genetic disorder. It was approved by the U.S. FDA in March 2022 under orphan drug designation.

What Is Hyftor (Sirolimus Topical Gel) Used For?

Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and pediatric patients 6 years of age and older. Facial angiofibroma is one of the most common and visible signs of TSC, appearing as red, raised lesions on the face that can cause significant psychosocial distress. Before Hyftor, management relied on invasive options such as laser treatment, cryotherapy, or surgery. Hyftor offers a non-invasive topical alternative that directly targets the mTOR overactivity underlying these lesions.

How Does Hyftor (Sirolimus Topical Gel) Work?

Hyftor delivers sirolimus directly to the skin, where it inhibits mTOR and suppresses the abnormal cell proliferation that forms facial angiofibromas. Tuberous sclerosis complex is caused by mutations in the TSC1 or TSC2 genes, which normally keep the mTOR pathway in check; when these genes are defective, mTOR becomes overactive and drives the growth of benign tumors and skin lesions. By applying sirolimus topically, the drug acts locally on the affected skin with minimal systemic exposure, providing a targeted and non-invasive approach.

Indications

Hyftor (sirolimus topical gel 0.2%) is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and pediatric patients 6 years of age and older. It is for topical use only and is not for oral, ophthalmic, or intravaginal use.

Dosage

Hyftor should be applied to the affected facial skin twice daily, in the morning and at bedtime. The maximum recommended daily amount is 600 mg (about 2 cm) for pediatric patients 6 to 11 years of age, and 800 mg (about 2.5 cm) for adults and children 12 years and older. If symptoms do not improve within 12 weeks, the need to continue treatment should be reevaluated. Occlusive dressings should not be used, and all age-appropriate vaccinations should be completed before starting.

Side Effects

The most common adverse reactions (in at least 1% of patients) are dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, and skin irritation. These are generally mild and localized. Because some systemic absorption occurs, patients should be monitored for hypersensitivity reactions, and the drug should be discontinued if significant local or systemic reactions develop.

Storage

Store Hyftor gel in its original tube, protected from light, and follow the cold-chain storage requirements specified by the manufacturer. Keep out of reach of children and use within the printed expiry period.

Why Choose the GLT?

Hyftor is the only FDA-approved topical therapy for TSC-associated facial angiofibroma, and as an orphan-designated product it is not yet routinely available in mainland China. Its overseas list price reflects both its orphan status and the specialized cold-chain distribution it requires. For patients and caregivers seeking access to this first-of-its-kind topical treatment, sourcing through a Hong Kong-licensed supplier such as GLT provides a verified channel with proper handling and full documentation, helping families obtain a non-invasive option that can meaningfully improve quality of life.

How to Order Hyftor (Sirolimus Topical Gel)

To order Hyftor, contact our team on WhatsApp at +86 15234153837 or by email at [email protected]. Please share the required quantity and your destination country so we can confirm availability, documentation, and delivery terms.

FAQ

Is Hyftor the same as oral sirolimus? No. Hyftor is a topical gel formulation of sirolimus applied directly to the skin, not the oral tablet used in transplantation.

Who makes Hyftor? Hyftor is developed by Nobelpharma of Japan and distributed in the United States by Nobelpharma America, LLC.

What is facial angiofibroma? It is a common, highly visible skin manifestation of tuberous sclerosis complex, appearing as red, raised lesions on the face.

How is Hyftor applied? It is applied to the affected facial skin twice daily, in the morning and at bedtime, using a thin layer.