Posology : מינונים

4.2    Posology and method of administration

Visudyne should be administered only by ophthalmologists experienced in the management of patients according to the indications mentioned above.

Posology
Adults, including the elderly (≥65 years old)
Visudyne photodynamic therapy (PDT) is a two-step process:

The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/m2 body surface area, diluted in 30 ml infusion solution (see section 6.6).

The second step is the light activation of Visudyne at 15 minutes after the start of the infusion (see “Method of administration”).

Patients should be re-evaluated every 3 months. In the event of recurrent CNV leakage, Visudyne therapy may be given up to 4 times per year.


VIS API-NOT OCT18 CL V8                             1                             Ref: EU SmPC July 2018 Treatment of the second eye with Visudyne
There are no clinical data to support concomitant treatment of the second eye. However, if treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion.

Special populations

Hepatic impairment
Visudyne therapy should be considered carefully in patients with moderate hepatic dysfunction or biliary obstruction. No experience is available in these patients. Since verteporfin is excreted primarily via the biliary (hepatic) route, increased verteporfin exposure is possible. Verteporfin exposure is not significantly increased in patients with mild hepatic impairment (see “Biotransformation” and “Elimination” under section 5.2) and does not require any dose adjustment.

Visudyne is contraindicated in patients with severe hepatic impairment (see section 4.3).

Renal impairment
Visudyne has not been studied in patients with renal impairment. However, the pharmacological characteristics do not indicate any need to adjust the dose (see “Biotransformation” and “Elimination” under section 5.2).

Paediatric population
The safety and efficacy of Visudyne in the paediatric population have not been established. Visudyne is not indicated in this population.

Method of administration

This medicinal product is intended for intravenous infusion only.
For the light activation of Visudyne, a diode laser generating non-thermal red light (wavelength 689 nm ± 3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens. At the recommended light intensity of 600 mW/cm2, it takes 83 seconds to deliver the required light dose of 50 J/cm2.

The greatest linear dimension of the choroidal neovascular lesion is estimated using fluorescein angiography and fundus photography. Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended. The treatment spot should cover all neovasculature, blood and/or blocked fluorescence. To ensure treatment of poorly demarcated lesion borders, an additional margin of 500 µm should be added around the visible lesion. The nasal edge of the treatment spot must be at least 200 m from the temporal edge of the optic disc. The maximum spot size used for the first treatment in the clinical studies was 6,400 m. For treatment of lesions that are larger than the maximum treatment spot size, apply the light to the greatest possible area of active lesion.

It is important to follow the above recommendations to achieve the optimal treatment effect.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.