Sirolimus topical

Generic name: Sirolimus Topical
Brand names: Hyftor
Dosage form: topical gel (0.2%)

Usage of Sirolimus topical

Sirolimus topical is used on the skin to treat people 6 years and older with a type of tumor called angiofibroma on your face caused by the genetic condition tuberous sclerosis.

Sirolimus topical may also be used for purposes not listed in this medication guide.

Sirolimus topical side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sirolimus topical may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Sirolimus topical may cause serious side effects. Stop using sirolimus topical and call your doctor at once if you have:

signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or

chest pain, shortness of breath, or new or worsening cough.

Common side effects of sirolimus topical may include:

acne, rash, skin bleeding, dry skin;

irritation at the treatment site;

itching; or

eye redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Sirolimus topical

You should not use sirolimus topical if you are allergic to it.

Tell your doctor if you have ever had:

skin infection at the treatment site;

high blood cholesterol or high triglycerides (fat or lipids); or

if you are scheduled to receive a vaccine.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using sirolimus topical and for at least 12 weeks after your last dose. Tell your doctor if you become pregnant.

Sirolimus topical may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using sirolimus topical.

Do not breastfeed.

How to use Sirolimus topical

Usual Adult Dose for Angiofibroma:

Usual dose: Apply to the skin of the face affected with angiofibroma twice daily, in the morning and at bedtime.Maximum dose: 800 mg (2.5 cm) Comment:If symptoms do not improve after 12 weeks of treatment, reassess the need for continuation of this drug.Use: Topical treatment of facial angiofibroma associated with tuberous sclerosis

Usual Pediatric Dose for Angiofibroma:

Usual dose: Apply to the skin of the face affected with angiofibroma twice daily in the morning and at bedtime.Maximum dose: 600 mg (2 cm) for patients 6 to 11 years of age, 800 mg (2.5 cm) for patients 12 to 18 years of ageComment:If symptoms do not improve after 12 weeks of treatment, reassess the need for continuation of this drug.Use: Topical treatment of facial angiofibroma associated with tuberous sclerosis

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What other drugs will affect Sirolimus topical

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect sirolimus topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

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