Frequently Asked Questions

What is TSC?

Tuberous sclerosis complex (TSC) is a genetic multisystemic disorder that causes widespread hamartomas throughout the body. These benign lesions can develop in many organs, including the brain, eyes, kidneys, liver, lungs, heart, and skin.1

What is facial angiofibroma?

Facial angiofibroma is one of the most predominant skin lesions in TSC. They are pink-to-red papules or nodules that are typically located on the cheeks, nose, and chin.2

What FDA-approved topical treatments were previously available to treat facial angiofibroma?

Many treatment options for facial angiofibroma were invasive therapies such as surgical procedures.2 Before HYFTOR™, there was no FDA-approved topical drug therapy for facial angiofibroma. HYFTOR is the first and only topical treatment for facial angiofibroma approved by the FDA.

What is HYFTOR?

HYFTOR™ (sirolimus topical gel) 0.2% is the first and only topical medication approved by the FDA to treat facial angiofibroma associated with TSC in adults and children 3 years of age and older.3

How can HYFTOR help treat facial angiofibroma?

HYFTOR has been shown to improve the size and redness of facial angiofibromas in clinical studies. Most patients in the study saw improvement in just 12 weeks of treatment.3 Click here to see clinical study results.

How can I prescribe HYFTOR?

Nobelpharma is committed to making access as simple and seamless as possible with specialty pharmacy services, including expediting the initiation of patient therapy.


We also offer Nobelpharma Connect to help patients fill prescriptions for HYFTOR as simply and seamlessly as possible.

When will HYFTOR be available in the United States?

HYFTOR is already approved by the FDA. HYFTOR will be available in October 2021. However, you can enroll patients now to help ensure a seamless transition.


HYFTOR™ (sirolimus topical gel) 0.2% is indicated for the treatment of angiofibroma associated with tuberous sclerosis in adults and children. HYFTOR™ (sirolimus topical gel) 0.2% is not indicated for children younger than 3 years of age.

Important Safety Information

The use of HYFTOR™ (sirolimus topical gel) 0.2% may cause local symptoms such as irritation (dry skin, dermatitis,
erythema, pruritus, acne). Localized symptoms are most common. Patients should be cautioned to stay out of direct

Please see accompanying Full Prescribing Information.