Pronunciation:

sir-OH-li-mus

Brand Names:

• Hyftor

Dosage Forms:

• Gel/Jelly

Classifications:

Therapeutic—

Immune Suppressant

Uses of This Medicine:

Sirolimus topical gel is used to treat facial angiofibroma (type of noncancerous tumor) caused by a genetic condition called tuberous sclerosis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sirolimus topical gel in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sirolimus topical gel in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole
• Mifepristone
• Posaconazole
• Ritonavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abrocitinib
• Adagrasib
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alefacept
• Amiodarone
• Asciminib
• Avacopan
• Bacillus of Calmette and Guerin Vaccine, Live
• Belzutifan
• Benazepril
• Berotralstat
• Boceprevir
• Cannabidiol
• Capmatinib
• Captopril
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Daridorexant
• Darunavir
• Dengue Tetravalent Vaccine, Live
• Duvelisib
• Efavirenz
• Elacestrant
• Enalapril
• Enalaprilat
• Enasidenib
• Enzalutamide
• Erdafitinib
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosinopril
• Fosnetupitant
• Gilteritinib
• Idelalisib
• Infliximab
• Influenza Virus Vaccine, Live
• Isavuconazonium Sulfate
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lanreotide
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lenacapavir
• Letermovir
• Lisinopril
• Lorlatinib
• Lumacaftor
• Mavacamten
• Measles Virus Vaccine, Live
• Methotrexate
• Metoclopramide
• Micafungin
• Mirabegron
• Mitapivat
• Mitotane
• Mobocertinib
• Moexipril
• Mumps Virus Vaccine, Live
• Neratinib
• Netupitant
• Nirmatrelvir
• Nirogacestat
• Octreotide
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Palbociclib
• Pazopanib
• Perindopril
• Phenobarbital
• Pirtobrutinib
• Poliovirus Vaccine, Live
• Primidone
• Quinapril
• Ramipril
• Repotrectinib
• Ribociclib
• Rifampin
• Ritlecitinib
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Saquinavir
• Selpercatinib
• Simeprevir
• Smallpox Vaccine
• Sotorasib
• Sparsentan
• St John's Wort
• Tacrolimus
• Taurursodiol
• Telaprevir
• Telithromycin
• Tepotinib
• Tocilizumab
• Trandolapril
• Trofinetide
• Tucatinib
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Venetoclax
• Verapamil
• Vilazodone
• Vonoprazan
• Voxelotor
• Yellow Fever Vaccine
• Zofenopril
• Zoster Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Aprepitant
• Diltiazem
• Erythromycin
• Fosphenytoin
• Nevirapine
• Phenytoin
• Rifabutin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hyperlipidemia (high amount of cholesterol and fats in the blood) or
• Skin infection at the affected areas—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.

To use the topical gel:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected area. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (gel):
  • For facial angiofibroma caused by tuberous sclerosis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin 2 times a day, in the morning and at bedtime. The dose is usually not more than 800 milligrams (mg) or 2.5 centimeters (cm) applied to the affected area of the skin per day.
    • Children 6 to 11 years of age—Apply to the affected area of the skin 2 times a day, in the morning and at bedtime. The dose is usually not more than 600 mg or 2 cm applied to the affected area of the skin per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect from light.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 12 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If your or your child's symptoms do not improve within 12 weeks of treatment, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

Check with your doctor right away if you have chest pain, cough, difficult breathing, fever, general feeling of discomfort or illness, or thickening of bronchial secretions. These may be symptoms of serious lung or breathing problems, including interstitial lung disease, pneumonitis, or pulmonary fibrosis.

This medicine may cause serious infections, including progressive multifocal leukoencephalopathy (PML). Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

This medicine may increase risk of cancer (eg, lymphoma, skin cancer). Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Wear protective clothing, including a hat and sunglasses.

While you are being treated with sirolimus topical gel, do not have any immunizations (live vaccines) without your doctor's approval.

This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

Do not use this medicine for a skin problem that has not been checked by your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blemishes on the skin

burning, itching, redness, skin rash, swelling, or soreness at the application site

dry skin

pimples

Less common

Redness of the eye

redness or stinging of the skin

Incidence not known

Back pain

black, tarry stools

blurred vision

chest pain or tightness

confusion

cough

cracks in the skin

difficulty breathing

difficulty swallowing

dizziness

drowsiness

fast heartbeat

fever

general feeling of illness

headache

hives, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of heat from the body

persistent non-healing sore

pink growth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, swollen skins

reddish patch or irritated area

scaly skin

seizures

shiny bump

swollen glands

thickening of bronchial secretions

unusual tiredness or weakness

weight loss

white, yellow or waxy scar-like area

yellow skin and eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.