Frequently Asked Questions

What is TSC?

Tuberous sclerosis complex (TSC) is a rare genetic disease that causes noncancerous tumors to grow throughout

the body. These tumors can develop in many organs, including the brain, eyes, kidneys, liver, lungs, heart, and skin.

What is facial angiofibroma?

Facial angiofibroma is one of the most common skin conditions associated with TSC. The angiofibromas are pinkish or reddish bumps that are usually located on the cheeks, nose, and chin.

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

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 for adults and children 6 years and older.

What is HYFTOR^®?

HYFTOR^® is the first and only topical medication approved by the FDA to treat facial angiofibroma associated with TSC for adults and children 6 years of age and older. HYFTOR^® is a clear gel that contains the mTOR inhibitor sirolimus.

Who should not use HYFTOR^®?

It is not known if HYFTOR^® is safe and effective in children under 6 years of age. Do not use HYFTOR^® if you are allergic to sirolimus or any of the other ingredients in HYFTOR^®. See Patient Information for a complete list of ingredients.

What are the most common side effects of HYFTOR^®?

The most common side effects of HYFTOR^® include dry skin, application site irritation, itching, acne, acne-like rash, eye redness, skin bleeding, and skin irritation. These are not all the possible side effects of HYFTOR^®. Please see Patient Information for more information. To report suspected side effects, call 1-877-375-0825. You may also contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I tell my doctor before starting HYFTOR^®?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HYFTOR^® and certain medicines may affect each other, causing side effects. Also, tell your healthcare provider about all of your medical conditions. Please see Patient Information for a list of specific conditions you should discuss.

How should I use HYFTOR^®?

Use HYFTOR^® exactly as your healthcare provider tells you to use it. Before you use HYFTOR^®, your healthcare provider or pharmacist should show you how to correctly measure your dose. Wash your hands before and after applying HYFTOR^®. Apply HYFTOR^® to the skin of the face affected with angiofibroma 2 times a day, in the morning and at bedtime. Do not cover, wrap, apply dressings, or bandage the skin area treated with HYFTOR^®. Tell your healthcare provider if the treated skin area does not improve within 12 weeks of treatment.

What should I avoid while using HYFTOR^®?

Limit your exposure to sunlight and ultraviolet light, such as tanning beds and ultraviolet light therapy, during treatment with HYFTOR^®. Wear clothing that covers your skin if you need to go outside. Talk with your healthcare provider about other ways you can protect your skin from the sun. Please see Patient Information for more information.

How can I get access to HYFTOR^®?

Talk to your doctor. You and your doctor should always discuss the best treatment options for you.

Important Safety Information

What is HYFTOR^®?

HYFTOR^® is a prescription medicine that is used on the skin (topical) to treat adults and children 6 years of age and older with a type of noncancerous tumor called angiofibroma on your face caused by the genetic condition tuberous sclerosis.

It is not known if HYFTOR^® is safe and effective in children under 6 years of age.

Important: HYFTOR^® is for use on the skin only (topical use). Do not use HYFTOR^® in your mouth, eyes, or vagina.

Do not use HYFTOR^® if you are allergic to sirolimus or any of the other ingredients in HYFTOR^®.

Before using HYFTOR^®, tell your healthcare provider about all of your medical conditions, including if you:

have a skin infection at the treatment site
have high cholesterol or high triglycerides (fat or lipids) in your blood
are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with HYFTOR^®. Vaccines may be less effective during treatment with HYFTOR^®.
are pregnant or plan to become pregnant. HYFTOR^® may harm your unborn baby. You should not become pregnant during treatment with HYFTOR^®.
- Females who are able to become pregnant should use effective birth control (contraception) before starting treatment with HYFTOR^®, during treatment, and for 12 weeks after your final dose of HYFTOR^®. Talk to your healthcare provider about types of birth control that you can use during this time.
are breastfeeding or plan to breastfeed. It is not known if HYFTOR^® passes into your breast milk. You should not breastfeed during treatment with HYFTOR^®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using HYFTOR^®?

Limit your exposure to sunlight and artificial light, such as tanning beds and ultraviolet light therapy, during treatment with HYFTOR^®. Wear clothing that covers your skin if you need to go outside. Talk with your healthcare provider about other ways you can protect your skin from the sun.

What are possible side effects of HYFTOR^®? HYFTOR^® may cause serious side effects, including:

Allergic reactions. Serious allergic reactions have happened in people who have taken sirolimus by mouth. Stop using HYFTOR^® and get medical help right away if you get any of these symptoms: swelling of your face, eyes, or mouth, trouble breathing or wheezing, throat tightness, chest pain or tightness, feeling dizzy or faint, rash or peeling of your skin.
Serious infections, including infections that can happen when your immune system is weak, have happened in people who have taken sirolimus by mouth. Some people have developed a rare, serious brain infection called progressive multifocal leukoencephalopathy (PML) which can sometimes cause death. Stop using HYFTOR^® and call your healthcare provider right away if you get symptoms of an infection including fever or chills.
Risk of cancer. Lymphoma and other cancers, especially skin cancer, have happened in people who have taken sirolimus by mouth. Talk with your healthcare provider about your risk for cancer if you use HYFTOR^®.
Increased levels of cholesterol and triglycerides (fat or lipids) in the blood have happened in people who have taken sirolimus by mouth. Your healthcare provider will treat you for high lipid levels, if needed.
Lung or breathing problems. Lung or breathing problems, including problems that have sometimes caused death, have happened in people who have taken sirolimus by mouth. Stop using HYFTOR^® and get medical help right away if you get symptoms such as shortness of breath, new or worsening cough, or chest pain.

The most common side effects of HYFTOR^® include dry skin, application site irritation, itching, acne, acne-like rash, eye redness, skin bleeding, and skin irritation.

HYFTOR^® may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effect of HYFTOR^®, Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Information for additional safety information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also reach out to Nobelpharma America, LLC at 1-877-375-0825