VISUDYNE Powder for solution for infusion Ref.[9470] Active ingredients: Verteporfin

Visudyne should be administered only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia.

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.

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 μm from the temporal edge of the optic disc. The maximum spot size used for the first treatment in the clinical studies was 6,400 μm. 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.

Overdose of the medicinal product and/or light in the treated eye may result in non-selective nonperfusion of normal retinal vessels, with the possibility of severe vision decrease.

Overdose of the medicinal product may result in the prolongation of the period during which the patient remains photosensitive. In such cases, the patient should prolong skin and eye protection from direct sunlight or bright indoor light for a period proportionate with the overdose given.

Shelf-life in the sealed vial: 4 years.

Shelf-life after reconstitution and dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.

Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

15 mg of powder for solution for infusion in a single-use glass vial (type I), sealed with bromobutyl stopper and aluminium flip-off cap.

Pack containing 1 vial.

Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution. Reconstituted Visudyne is an opaque dark green solution. It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration. For a dose of 6 mg/m² body surface (see section 4.2) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5%) solution for infusion to a final volume of 30 ml. Do not use sodium chloride solution (see section 6.2). Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.

The vial and any unused portion of reconstituted solution should be discarded after single use.

If material is spilled, it should be contained and wiped up with a damp cloth. Eye and skin contact should be avoided. Use of rubber gloves and eye protection is recommended. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.