Active Ingredient: Sirolimus
Sirolimus is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 6 and patient age in years is ≤ 11
Cutaneous, 1.2 milligrams sirolimus, divided 2 times daily.
Regimen B, in case that patient age in years is ≥ 12
Cutaneous, 1.6 milligrams sirolimus, divided 2 times daily.
This medicinal product should be applied to the affected area twice daily (in the morning and at bedtime). The application should be limited to skin areas with angiofibroma.
A dose of 0.25 mg sirolimus should be administered per 50 cm² lesion in the face.
The maximum recommended daily dose in the face is:
The dose should be equally divided for two administrations.
If the first dose was missed in the morning, the application should be done immediately upon realisation of the fact provided this was before dinner of the same day. Otherwise only the application in the evening should be administered on that day. If the application in the evening was missed this should not be taken at a later point in time.
No dose adjustment is required in elderly patients (≥65 years).
For cutaneous use only.
Application should be limited to areas of facial angiofibroma lesions.
A thin layer of gel should be administered to the affected skin and rubbed in gently. The application site should not be occluded.
The gel should not be applied around the eyes and on the eyelids.
In case no treatment effect appears, administration with Hyftor should be discontinued after 12 weeks.
Hands should be washed carefully before and after administration of the gel to ensure that no gel remains on the hands that may be accidentially ingested or trigger exposure to sirolimus of any other part of the body or other persons.
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