VISUDYNE FOR INJECTION 15 MG/VIAL [SIN11608P]

Product Info

VISUDYNE FOR INJECTION 15 MG/VIAL

[SIN11608P]

INDICATIONS

Visudyne is indicated for the treatment of patients with subfoveal Choroidal Neovascularisation (CNV) that is:

• predominantly classic and due to age-related macular degeneration

• occult and due to age-related macular degeneration

• due to pathologic myopia

DOSAGE AND ADMINISTRATION

Visudyne therapy should only be administered by ophthalmologists experienced in the management of patients with age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

Dosage

General target population (Adults)

Visudyne therapy 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 INSTRUCTIONS FOR USE AND HANDLING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 and retreated in the event of recurrent CNV leakage. In the event of recurrent CNV leakage, Visudyne therapy may be given up to 4 times per year.

Special populations

Hepatic impairment

Visudyne therapy should be considered carefully in patients with moderate to severe hepatic impairment 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 section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and does not require any dose adjustment.

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 section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatrics patients

Use in the paediatric population has not been investigated. Visudyne is not indicated in this population.

Geriatric patients (65 years of age or above)

The posology is the same in the elderly (aged 65 years and above) as in younger adults.

Method of administration

This medicinal product is intended for intravenous infusion only.

For this, 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 to 2.6-fold 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 micrometers should be added around the visible lesion. The nasal edge of the treatment spot must be at least 200 micrometers from the temporal edge of the optic disc. The maximum spot size used for the first treatment in the clinical studies was 6,600 micrometers. 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.

CONTRAINDICATIONS

Visudyne is contraindicated in patients with porphyria or a known hypersensitivity to verteporfin or to any of the excipients of Visudyne and in patients with severe hepatic impairment.