About HYFTOR - HYFTOR® Patient Site

An FDA-Approved Topical Gel

HYFTOR^® is a clear gel that contains 0.2% of the prescription medication sirolimus (an mTOR inhibitor). It is the first and only topical medication approved by the Food and Drug Administration (FDA) to treat facial angiofibroma in tuberous sclerosis complex (TSC) in adults and children 6 years of age and older.

Application

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 is:

Approximately 3/4 inch of gel (600 mg) for pediatric patients 6 to 11 years of age
Approximately 1 inch of gel (800 mg) for adults and pediatric patients 12 years of age and older

Talk to your doctor about your dosage and how to apply HYFTOR^®. HYFTOR^® is only for topical use on the area of the face affected with angiofibroma. The skin being treated with HYFTOR^® should not be covered with bandages, dressings, or wraps.

Wash your hands before and after applying HYFTOR^®
Tell your healthcare provider if the treated skin area does not improve within 12 weeks of treatment

Results

In a clinical trial, improvement was seen at 12 weeks.

23% of patients had their facial angiofibroma assessed as “improved” or “markedly improved” after 12 weeks
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
62 patients participated in the trial (including 25
patients between 6 and 18 years of age)
The patients applied either HYFTOR^® or a placebo
(a gel containing no medication) to their faces
twice daily for 12 weeks
Results were reported at the end of 12 weeks. The
improvement in size and redness of facial
angiofibromas was assessed by the investigator
(live assessment) using the subjects’ original
baseline photographs as reference

Move the slider back and forth to see before-and-after results of the patient

Individual results may vary.

Improvements in Facial Angiofibroma*

60% of patients treated with HYFTOR were markedly improved or improved after 12 weeks compared with 0% of patients treated with the placebo

SIDE EFFECTS

The most common side effects, occurring in 1% or more of patients treated with HYFTOR^®, are:

Dry skin
Application site irritation
Itching
Acne

Acne-like rash
Eye redness
Skin bleeding
Skin irritation

These are not all the side effects associated with HYFTOR^®. Please see additional Important Safety Information below and the Patient Information for more information. Before you start using HYFTOR^®, you and your doctor should talk about all of your medical conditions, medicines you take, and skin products you use.

To report suspected side effects, contact Nobelpharma America, LLC, at 1-877-375-0825. You may also contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

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