HYFTOR Gel Ref.[50985] Active ingredients: Sirolimus

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.

A dose of 125 mg gel (or 0.5 cm gel, corresponding to 0.25 mg sirolimus) should be administered per 50 cm² lesion in the face.

The maximum recommended daily dose in the face is:

• Patients aged 6-11 years should apply up to 600 mg gel (1.2 mg sirolimus), corresponding to approximately 2 cm gel strand per day.
• Patients aged ≥12 years should apply up to 800 mg gel (1.6 mg sirolimus), corresponding to approximately 2.5 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.

Special populations

Elderly

No dose adjustment is required in elderly patients (≥ 65 years) (see section 5.2).

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. However, no dose adjustment is required in this population since systemic exposure to sirolimus is low in individuals using Hyftor (see section 4.4).

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. Currently available data are presented in section 5.2 but no recommendation on a posology can be made.

Method of administration

For cutaneous use only.

Application should be limited to areas of facial angiofibroma lesions (see section 4.4.).

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 (see section 4.4).

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.

If accidentally ingested, general supportive measures may be appropriate. Due to the poor aqueous solubility and high erythrocyte and plasma protein binding, sirolimus will not be dialysable to a significant extent.

15 months

Shelf life after first opening: 4 weeks.

Store in a refrigerator (2°C–8°C).

Store in the original package in order to protect from light.

Keep away from fire.

Aluminium tube with high density polyethylene closure.

Pack size: 1 tube containing 10 g of gel.

Any remaining medicinal product, as well as the materials used for its administration, must be destroyed in accordance with the procedure applicable for cytotoxic agent and in compliance with current legislation relating to the elimination of hazardous waste.