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Verteporfin

Indications

Verteporfin therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

There is insufficient evidence to indicate Verteporfin for the treatment of predominantly occult subfoveal choroidal neovascularization.

Pharmacology

Verteporfm, when activated by low-intensity nonheat-generating laser light at a wavelength corresponding to its absorption peak, generates highly reactive, shortlived singlet 02 and reactive 02 radicals that cause local damage to neovascular endothelium, resulting in vessel occlusion. It appears to accumulate preferentially in the neovasculature e.g. choroidal neovasculature.

Dosage & Administration

A course of verteporfin therapy is a two-step process requiring administration of both drug and light. The first step is the intravenous infusion of Verteporfin. The second step is the activation of Verteporfin with light from a nonthermal diode laser. The physician should reevaluate the patient 3 months after treatment and if choroidal neovascular leakage is detected on fluorescein angiography, therapy may be repeated.

Lesion Size Determination: The greatest linear dimension (GLD) of the lesion should be estimated by fluorescein angiography and color fundus photography. All classic and occult CNV, blood and/or blocked fluorescence, and any serous detachments of the retinal pigment epithelium should be included for this measurement. Fundus cameras with magnification within the range of 2.4-2.6X are recommended. The GLD of the lesion on the fluorescein angiogram must be corrected for the magnification of the fundus camera to obtain the GLD of the lesion on the retina.

Spot Size Determination: The treatment spot size should be 1000 microns larger than the GLD of the lesion on the retina to allow a 500 micron border, ensuring full coverage of the lesion. The maximum spot size used in the clinical trials was 6400 microns.

The nasal edge of the treatment spot must be positioned at least 200 microns from the temporal edge of the optic disc, even if this will result in lack of photoactivation of CNV within 200 microns of the optic nerve.

Interaction

Increased rate of verteporfm uptake by the vascular endothelium with calcium channel blockers, polymyxin B or radiation therapy. Increased photosensitivity with photosensitizing agents (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics and griseofulvin). Decreased verteporfm efficacy with compounds that quench active oxygen species or scavenge radicals e.g. dimethyl sulfoxide, betacarotene, ethanol, formate and mannitol. Decreased verteporfm efficacy with drugs that decrease clotting, vasoconstriction or platelet aggregation e.g. thromboxane A2 inhibitors. Anaesthetics may cause haemodynamic effects.

Contraindications

Verteporfin is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation

Side Effects

Visual disturbances; severe vision loss with or without subretinal or vitreous bleeding; inj site reactions; nausea; photosensitivity; asthenia; cataracts; blepharitis; conjunctivitis; dry eyes; ocular itching; flu-like syndrome; atrial fibrillation; hypertension; peripheral vascular disorder; varicose veins; eczema; constipation; Gl cancers; fever; lachrymation disorder; hypersensitivity reactions; increased LFT.

Pregnancy & Lactation

Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Precautions & Warnings

Moderate to severe hepatic disorders; biliary disorders. Pregnancy. Use the largest arm vein possible (e.g. antecubital) especially in elderly and avoid small veins in the back of the hand. Stop infusion if extravasation occurs and protect extravasation area from direct light and apply cold compresses. Patient to be under close monitoring during verteporfm infusion and exercise caution when general anaesthesia is considered. Avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light for 5 days after treatment. Protect all parts of skin and eyes by wearing protective clothing and dark sunglasses (sunscreens are ineffective) if going outdoors in daylight is necessary. Exposure to ambient indoor light is encouraged as it helps in gradual inactivation of any remaining drug.

Use in Special Populations

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Approximately 90% of the patients treated with Verteporfin in the clinical efficacy trials were over the age of 65. A reduced treatment effect was seen with increasing age.

Overdose Effects

Overdose of drug and/or light in the treated eye may result in non-perfusion of normal retinal vessels with the possibility of severe decrease in vision that could be permanent. An overdose of drug will also result in the prolongation of the period during which the patient remains photosensitive to bright light. In such cases, it is recommended to extend the photosensitivity precautions for a time proportional to the overdose.

Therapeutic Class

Drugs for Age-Related Macular Degeneration (AMD)
Visudyne Injection 15 mg vial

Visudyne Injection 15 mg vial

IndicationsVerteporfin therapy is indicated for the treatment of patients with predominantly classic..

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