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Overview: Hyftor is used to treat angiofibromas, which are skin growths on the face caused by a genetic disorder. It is a topical gel that is applied to the skin. Hyftor may work by blocking signals in your body that control cell growth. Common side effects include skin dryness, irritation, itchiness, and acne. After applying Hyftor to your skin, do not wrap, bandage, or cover the treated area.

Uses

What is Hyftor used for?

Hyftor (sirolimus) is commonly used to treat angiofibromas on the face, which are skin growths caused by tuberous sclerosis, a genetic disorder. 

Hyftor may also be used for other conditions as determined by your health care provider.

How does Hyftor work (mechanism of action)?

People with tuberous sclerosis have an overgrowth of skin and other cells, which can lead to noncancerous tumors on the face and in the body. Hyftor blocks a pathway in the body called the mTOR pathway, which helps control cell growth. By blocking this pathway, Hyftor may help shrink or reduce skin growths on the face (angiofibromas). 

How is Hyftor supplied (dosage forms)?

Brands and other names

  • Hyftor

Dosage forms and strengths

  • 0.2% topical gel

Sirolimus (the active ingredient in Hyftor) is also available in forms that are taken by mouth. See Sirolimus for more information.

How should I store Hyftor?

Hyftor should be stored in a refrigerator, between 36 F and 46 F (2 C and 8 C). Keep the tube tightly closed and protect it from light.

Side Effects

What are the most common side effects of Hyftor?

The most common side effects of Hyftor are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Skin dryness
  • Irritation where you apply the gel to your skin
  • Itchiness
  • Acne or small bumps on the skin that look like acne
  • Eye redness
  • Skin bleeding

There may be other side effects of Hyftor that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Hyftor?

While less common, the most serious side effects of Hyftor are described below, along with what to do if they happen. Some of these side effects were seen in people taking sirolimus (the active ingredient in Hyftor) by mouth.

Severe Allergic Reactions. Hyftor may cause allergic reactions, which can be serious. Stop using Hyftor and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat, especially when used with certain other medicines
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Skin peeling or flaking
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Chest pain or tightness

Infections. Hyftor may increase your risk for infections, including serious infections that can be life-threatening. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Fever, sweats, chills, or muscle aches
  • Feeling more tired than usual
  • Sore throat
  • Cough or coughing up blood
  • Burning or stinging when you pee
  • Shortness of breath
  • Diarrhea or stomach pain

Cancer. Hyftor may cause a new cancer to develop, including blood cancer or skin cancer, or cause a previously treated cancer to come back. Try to avoid or limit being in light from the sun, sunlamps, and tanning beds while using Hyftor. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin. Tell your health care provider about any new symptoms or skin changes.

High Cholesterol Levels (Hyperlipidemia). Hyftor may increase the levels of fats in your blood, which may cause high cholesterol and triglycerides. This does not usually cause symptoms, but it can lead to serious health problems if left untreated. Keep all appointments to have blood tests while using Hyftor. 

Lung Inflammation. Hyftor may cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

Warnings & Precautions

Who should not use Hyftor?

Allergies to Ingredients. People who are allergic to any of the following should not use Hyftor.

  • Hyftor
  • Sirolimus
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Hyftor.

What should I know about Hyftor before using it?

Do not use Hyftor unless it has been prescribed to you by a health care provider. Use it as prescribed. 

Do not share Hyftor with other people, even if they have the same condition as you. It may harm them.

Keep Hyftor out of the reach of children. Because Hyftor should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator. 

Only use Hyftor on your skin. Avoid getting the medicine in the mouth, eyes, or vagina. Wash your hands before and after use.

After applying Hyftor to your skin, do not wrap, bandage, or cover the treated area.

If your skin does not get better after using Hyftor for three months, tell your health care provider.

Hyftor may cause fertility problems. Tell your health care provider if you have questions or concerns about this.

What should I tell my health care provider before using Hyftor?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Hyftor is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your health care provider about any vaccines that you may need before starting treatment with Hyftor. You should not receive certain vaccines while using Hyftor. Tell your health care provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Hyftor may interact with other medicines and supplements. Before using Hyftor, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

  • High levels of fats in your blood (high cholesterol or triglycerides)
  • A skin infection at or near the affected area
  • Cancer

Pregnancy. Hyftor may cause harm to an unborn baby. You should not become pregnant while using Hyftor. If you are able to get pregnant, you should use effective birth control before starting Hyftor, while using the medicine, and for 12 weeks after your last dose. Tell your health care provider right away if you  become pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Hyftor passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop using Hyftor.

How can I get more information about Hyftor?

For more information about Hyftor, you can visit the drugmaker’s website at www.hyftor.com or call them at 887-375-0825.

Interactions

Does Hyftor interact with foods or drinks?

There are no known interactions between Hyftor and foods or drinks.

It is unknown if drinking alcohol will affect Hyftor.

Does Hyftor interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Hyftor may alter the blood levels of some other medicines, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Hyftor?

If you or someone else has used too much Hyftor, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Hyftor?

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.