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Prescribing Information

Patient Information

Important Safety Information

About HYFTOR® (sirolimus topical gel) 0.2%

HYFTOR® is the first and only topical medication approved by the FDA to treat facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and children 6 years and older. HYFTOR® is a clear gel that contains an mTOR inhibitor.
Uncapped HYFTOR Tube Photo

Dosage and Administration

HYFTOR® should be applied to the skin of the face affected with angiofibroma twice daily, in the morning and at bedtime. The maximum recommended daily dosage is1:

  • 600 mg (2 cm/~.75 in) for pediatric patients 6 to 11 years of age
  • 800 mg (2.5 cm/~1 in) for adults and pediatric patients 12 years of age and older
    • Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to HYFTOR® initiation
    • If symptoms do not improve within 12 weeks of treatment, reevaluate the need for continuing HYFTOR®
    • Do not use HYFTOR® with occlusive dressings
    • For topical use only. Not for oral, ophthalmic, or intravaginal use

Efficacy

Improvement was seen at 12 weeks in the pivotal trial. 1

  • With HYFTOR® , 23% of patients were assessed as “improved” or “markedly improved” at 12 weeks
  • With placebo, 6% of patients were assessed as “improved” or “markedly improved” at 12 weeks

Study Design and Details

A single randomized, double-blind, placebo-controlled, multicenter phase 3 study was conducted to evaluate HYFTOR® for the treatment of adults and pediatric patients 6 years of age and older with facial angiofibroma associated with TSC1:

  • 62 patients enrolled in the study, including 25 between 6 and 18 years of age
  • Patients applied either HYFTOR® or a placebo vehicle gel twice daily to the skin of their face affected with angiofibroma for 12 weeks
  • The efficacy was assessed by the investigator (live assessment) based on the composite improvement from baseline in size and redness of facial angiofibromas, using subjects’ baseline photographs as reference
  • An assessment of “improved” was defined as at least a 50% reduction in size and a 2-level reduction in redness, and an assessment of “markedly improved” was defined as at least a 75% reduction in size and a 3-level reduction in redness

Safety

The most common adverse reactions (≥1%) are1:

  • Dry skin
  • Application site irritation
  • Pruritus
  • Acne
  • Acneiform dermatitis
  • Ocular hyperemia
  • Skin hemorrhage
  • Skin irritation

For a complete list of adverse reactions, please consult the full Prescribing Information.

  1. HYFTOR® Gel 0.2% Prescribing Information. Nobelpharma America, LLC; 2021.

Indication and Important Safety Information
Indication   HYFTOR® is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.
Important Safety Information
Contraindications   HYFTOR® is contraindicated in patients with a history of hypersensitivity to sirolimus or any other component of HYFTOR®.