Sirolimus (Topical application)

Sirolimus topical gel is used to treat facial angiofibroma, a type of noncancerous tumor, caused by a genetic condition known as tuberous sclerosis.

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

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for at least 12 weeks after the last dose. If you think you may have become pregnant while using this medicine, inform your doctor immediately.

If your or your child's symptoms do not improve within 12 weeks of treatment, or if they worsen, consult your doctor.

This medicine may cause serious allergic reactions, such as anaphylaxis and angioedema. Contact your doctor immediately if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large 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.

Contact your doctor right away if you experience chest pain, cough, difficulty breathing, fever, a general feeling of discomfort or illness, or thickening of bronchial secretions. These may be signs 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). Consult your doctor if you experience weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

This medicine may increase the risk of cancer (e.g., lymphoma, skin cancer). Use sunscreen when outdoors. Avoid sunlamps and tanning beds. Wear protective clothing, such as a hat and sunglasses.

While being treated with sirolimus (Topical application), do not receive any immunizations (live vaccines) without your doctor's approval.

This medicine could cause infertility. Discuss 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 assessed by your doctor.

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

In deciding to use a medicine, the risks of taking the medicine need to be balanced against its benefits. This decision will be made together with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of sirolimus topical gel in children younger than 6 years of age. Safety and effectiveness have not been established for this age group.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the usefulness of sirolimus topical gel.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following is not recommended. Your doctor may choose 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 is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust 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
• Dabrafenib
• Daridorexant
• Darunavir
• Dengue Tetravalent Vaccine, Live
• Duvelisib
• Efavirenz
• Elacestrant
• Eluxadoline
• Enalapril
• Enalaprilat
• Enasidenib
• Enzalutamide
• Erdafitinib
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosinopril
• Fosnetupitant
• 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
• Octreotide
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Palbociclib
• Pazopanib
• Perindopril
• Phenobarbital
• Pirtobrutinib
• Poliovirus Vaccine, Live
• Primidone
• Quinapril
• Ramipril
• 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
• Voxelotor
• Yellow Fever Vaccine
• Zofenopril
• Zoster Vaccine, Live

Using this medicine with any of the following may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or how often you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may adjust the dose or how often you use this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to inform your doctor about any other medical issues, especially:

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away 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 skin
• 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.

In the U.S.

• Hyftor

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Immune Suppressant

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.