Sirolimus Topical Gel

What is this medication?

SIROLIMUS (sir OH li mus) treats facial angiofibroma associated with tuberous sclerosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): HYFTOR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• High cholesterol
• Infection
• Recent or upcoming vaccine
• An unusual or allergic reaction to sirolimus, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. Do not use on healthy skin or over large areas of skin. Do not get this medication in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your care team tells you to stop. Do not bandage or wrap the skin being treated.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

This medication may interact with the following:

• Certain antibiotics like clarithromycin, erythromycin, telithromycin
• Certain medications for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for HIV like atazanavir, darunavir, fosamprenavir, indinavir, lopinavir; ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir
• Cyclosporine
• Danazol
• Diltiazem
• Grapefruit juice
• Mifepristone, RU-486
• Nicardipine
• Vaccines
• Verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication can increase bad cholesterol and fats (such as triglycerides). You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication can decrease the response to a vaccine. If you need to get vaccinated, tell your care team if you have received this medication. Extra booster doses may be needed. Talk to your health care provider to see if a different vaccination schedule is needed.

Talk to your care team about your risk of skin cancer. You may be more at risk for skin cancer if you take this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

Do not become pregnant while taking this medication or for 12 weeks after stopping it. Women must use a form of birth control while taking this medication. Women will also need to take it for 12 weeks after stopping this medication. There is potential for serious harm to an unborn child. Tell your care team right away if you think you might be pregnant.

This medication may make it more difficult to get pregnant or father a child. It is usually temporary. Talk to your care team if you are concerned about your fertility.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek other source of medical care.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching, hives, swelling of the face, lips, tongue, or throat, arms, or legs, trouble swallowing or breathing
• Dry cough, shortness of breath or trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Acne
• Burning, itching, crusting, or peeling of treated skin
• Eye redness
• Mild skin irritation, redness, or dryness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in refrigerator. Protect from light.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.