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Drug overview for HYFTOR (sirolimus):
Generic name: sirolimus (sir-OH-li-mus)
Drug class: Macrolide Immunosuppressants - Topical
Therapeutic class: Dermatological
Sirolimus, a mammalian target of rapamycin (mTOR) inhibitor, is an immunosuppressive agent.
No enhanced Uses information available for this drug.
Generic name: sirolimus (sir-OH-li-mus)
Drug class: Macrolide Immunosuppressants - Topical
Therapeutic class: Dermatological
Sirolimus, a mammalian target of rapamycin (mTOR) inhibitor, is an immunosuppressive agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
HYFTOR 0.2% GEL
The following indications for HYFTOR (sirolimus) have been approved by the FDA:
Indications:
Facial angiofibroma associated with tuberous sclerosis complex
Professional Synonyms:
Facial angiofibroma due to tuberous sclerosis
Facial angiofibroma of tuberous sclerosis
Tuberous sclerosis complex-related facial angiofibroma
Indications:
Facial angiofibroma associated with tuberous sclerosis complex
Professional Synonyms:
Facial angiofibroma due to tuberous sclerosis
Facial angiofibroma of tuberous sclerosis
Tuberous sclerosis complex-related facial angiofibroma
The following dosing information is available for HYFTOR (sirolimus):
No enhanced Dosing information available for this drug.
Sirolimus is applied topically to the skin as a gel. The topical gel is for external use only and not for oral, ophthalmic, or intravaginal use. The safety of sirolimus topical gel under occlusion, which may promote systemic exposure, has not been evaluated.
Do not use sirolimus gel with occlusive dressings. Hands should be washed prior to and following application of the cream. Sirolimus topical gel should be refrigerated at 2-8degreesC.
Refrigerate immediately after application. Protect from light.
Do not use sirolimus gel with occlusive dressings. Hands should be washed prior to and following application of the cream. Sirolimus topical gel should be refrigerated at 2-8degreesC.
Refrigerate immediately after application. Protect from light.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| HYFTOR 0.2% GEL | Maintenance | Adults apply 1.25 centimeters (400 mg) to the affected area of the face by topical route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for HYFTOR (sirolimus):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for HYFTOR (sirolimus):
Drug contraindication overview.
*History of hypersensitivity to sirolimus or any ingredient in the formulation.
*History of hypersensitivity to sirolimus or any ingredient in the formulation.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Interstitial lung disease |
| Malignancy |
| Pregnancy |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hyperlipidemia |
| Male infertility |
The following adverse reaction information is available for HYFTOR (sirolimus):
Adverse reaction overview.
Most common adverse reactions (>=1%) with sirolimus gel in adults and pediatric patients >=6 years of age are dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, and skin irritation.
Most common adverse reactions (>=1%) with sirolimus gel in adults and pediatric patients >=6 years of age are dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, and skin irritation.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Influenza |
| Rare/Very Rare |
|---|
| None. |
There are 10 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acne vulgaris Acneiform eruption Bleeding skin Dry skin Ocular redness Pruritus of skin Skin irritation |
Contact dermatitis Ocular irritation Skin photosensitivity |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for HYFTOR (sirolimus):
The safety and effectiveness of sirolimus topical gel have been established in pediatric patients >=6 years of age for the treatment of facial angiofibroma associated with tuberous sclerosis. Use of sirolimus gel in this age group is supported by data from a randomized, vehicle-controlled, double-blind 12-week trial along with additional efficacy and long-term safety data from a 104-week open label safety trial. A total of 13 pediatric patients 6 to 17 years of age received sirolimus gel in the phase 3 clinical trial along with 48 pediatric patients 3 to 17 years of age in the 104-week open label safety trial.
Adverse reactions occurred with similar frequency in adult and pediatric subjects. The safety and effectiveness of sirolimus topical gel for the topical treatment of facial angiofibroma associated with tuberous sclerosis have not been established in pediatric patients <6 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Adverse reactions occurred with similar frequency in adult and pediatric subjects. The safety and effectiveness of sirolimus topical gel for the topical treatment of facial angiofibroma associated with tuberous sclerosis have not been established in pediatric patients <6 years of age.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on animal studies and mechanism of action, oral sirolimus can cause fetal harm when administered to a pregnant woman. Sirolimus topical gel is systemically absorbed after topical administration and may result in fetal exposure. The available data from case reports on sirolimus topical gel use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Animal reproduction studies have not been conducted with sirolimus topical gel. In an animal reproduction study with oral sirolimus, embryolethality occurred when sirolimus was administered orally to pregnant rats during the period of organogenesis. The available data do not allow the calculation of relevant comparisons between the systemic exposure of sirolimus observed in animal studies to the systemic exposure that would be expected in humans after topical use of sirolimus gel.
Animal reproduction studies have not been conducted with sirolimus topical gel. In an animal reproduction study with oral sirolimus, embryolethality occurred when sirolimus was administered orally to pregnant rats during the period of organogenesis. The available data do not allow the calculation of relevant comparisons between the systemic exposure of sirolimus observed in animal studies to the systemic exposure that would be expected in humans after topical use of sirolimus gel.
There are no available data on the presence of sirolimus in human milk; it is not known whether the drug has any effects on the breast-fed infant or on milk production. After oral administration, sirolimus was present in the milk of lactating rats. Because of the potential for serious adverse reactions in the breast-fed infant, the manufacturer states that breast-feeding is not recommended during treatment with sirolimus gel.
Clinical studies of sirolimus topical gel did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
The following prioritized warning is available for HYFTOR (sirolimus):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for HYFTOR (sirolimus)'s list of indications:
| Facial angiofibroma with tuberous sclerosis complex | |
| D23.39 | Other benign neoplasm of skin of other parts of face |
| Q85.1 | Tuberous sclerosis |
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