Hyftor

Posology 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. 25 mg sirolimus) should be administered per 50 cm2 lesion in the face.

2 mg sirolimus), corresponding to approximately 2 cm gel strand per day. 5 cm gel strand per day. The dose should be equally divided for two administrations. Missed dose 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. 2). Renal impairment No formal studies have been performed in patients with renal impairment.

However, no dose adjustment is required in this population since systemic exposure to sirolimus is low in individuals using Hyftor. Hepatic impairment No formal studies have been performed in patients with hepatic impairment. 4). Paediatric population The posology is the same in adults and children aged 12 years and older (up to a total of 800 mg gel per day).

The maximum dose for patients aged 6-11 years is a total of 600 mg gel per day. The safety and efficacy of Hyftor in children less than 6 years has not been established. 2 but no recommendation on a posology can be made. Method of administration For cutaneous use only.

). A thin layer of gel should be administered to the affected skin and rubbed in gently. The application site should not be occluded. 4). 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.

2%). These events were generally mild or moderate in intensity, nonserious, and did not lead to treatment discontinuation. Tabulated list of adverse reactions Adverse reactions reported from the clinical studies are listed in table 1 by system organ class and frequency using the following convention: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7% of patients treated with sirolimus gel in clinical studies. Application site irritation did not require discontinuation of treatment with the medicinal product.

7% of patients treated with sirolimus gel in clinical studies. Dry skin did not require discontinuation of treatment with the medicinal product. 4% of patients overall treated with sirolimus gel in clinical studies. Acne was of mild or moderate intensity; no severe acne was reported.

Acne/dermatitis acneiform did not require discontinuation of treatment with the medicinal product. 2% of patients treated with sirolimus gel in clinical studies. Pruritus did not require discontinuation of treatment with the medicinal product.

Paediatric population In clinical development, no difference was seen in the safety between paediatric patients aged 6 years and older and adult patients included in a Phase III study including 27 patients ≤ 18 years (Hyftor: n=13) and a long-term study including 50 patients ≤ 18 years (Hyftor: all).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Immunosupressed patients Although systemic exposure is much lower following topical treatment with Hyftor than after systemic treatment with sirolimus, the gel should not be used in immunocompromised adults and children as a precautionary measure.

Mucous membranes and damaged skin Hyftor should not be used on wounds, irritated skin or skin with a clinically confirmed diagnosis of infection as well as in patients with known skin barrier defects. Contact with eyes or mucous membranes (mouth, nose) should be avoided.

Therefore, the gel should not be applied around the eyes and on the eyelids. 3). Therefore, patients should avoid exposure to natural or artificial sunlight during the treatment period. Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing and/or headgear.

3) and in patients treated systemically for immunosuppression. Although systemic exposure is much lower during treatment with sirolimus gel than with systemically administered sirolimus, patients should minimise or avoid exposure to natural or artificial sunlight during therapy using the same measures as mentioned above, to prevent photosensitivity.

Lymphoproliferative disorders Lymphoproliferative disorders secondary to chronic systemic use of immunosuppressive agents have been reported in patients. Severe hepatic impairment Sirolimus is metabolised in the liver and blood concentrations are low following topical administration.

As a precautionary measure in patients with severe hepatic impairment, treatment should be discontinued in case any potential systemic side effects are observed. Hyperlipidaemia Increased serum levels of cholesterol or triglycerides have been observed during treatment with sirolimus, in particular after oral administration.

1.