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HYFTOR (sirolimus)
- facial angiofibroma with tuberous sclerosis complex
0.2 % topical gel
- Apply 1.25 centimeters (400 mg) to the affected area of the face by topical route 2 times per day
Default screening record
- Apply 1.25 centimeters (400 mg) to the affected area of the face by topical route 2 times per day
- None
Contraindicated
- None
Severe
Moderate
- None
- Lactation
Contraindicated
- Interstitial lung disease
- Malignancy
- Pregnancy
- Severe infection
Severe
Moderate
- Hyperlipidemia
- Male infertility
HYFTOR (sirolimus)
- facial angiofibroma with tuberous sclerosis complex
- None
- Acne vulgaris
- Acneiform eruption
- Bleeding skin
- Dry skin
- Ocular redness
- Pruritus of skin
- Skin irritation
More Frequent
Severe
Less Severe
- Influenza
- Contact dermatitis
- Ocular irritation
- Skin photosensitivity
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- None
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Sirolimus (topical)
Safety and effectiveness not established for pediatric patients age <6 years.
- 1 Day – 6 Years
- Safety and effectiveness not established for pediatric patients age <6 years.
Sirolimus
- Severity Level:
D
- Additional Notes: Based on animal data, fetal harm may occur.
Contraindicated
Sirolimus
Potential for adverse effects in infant.
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Potential for adverse effects in infant. |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Facial angiofibroma with tuberous sclerosis complex | |
| D23.39 | Other benign neoplasm of skin of other parts of face |
| Q85.1 | Tuberous sclerosis |
| 0-9 | A-Z |
|---|---|
| D23.39 | Other benign neoplasm of skin of other parts of face |
| Q85.1 | Tuberous sclerosis |
Formulary Reference Tool