Composition: Verteporfin 15mg.
Presentation: Powder for solution for infusion.
Storage and stability: Do not store above 25C. Keep vial in outer carton to protect from light. After reconstitution and dilution, protect from light until used. Use within a maximum of four hours.
Action: Photosensitising agent for photodynamic therapy.
Indications: Treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularisation (CNV).
Contraindications: Hypersensitivity to active substance or excipients; porphyria; severe hepatic impairment.
Dosage and administration: Verteporfin therapy is a two-step process. First step, a 10 minute, intravenous infusion at a dose of 6mg/m2 body surface area, diluted in 30ml infusion solution (see SPC for reconstitution). Second step, light activation of verteporfin 15 minutes after the start of infusion (see SPC). Patients should be re-evaluated every three months. For recurrent CNV leakage, verteporfin therapy may be given up to four times a year.
Hepatic impairment or biliary obstruction, no experience has been gained in these patients. Therapy should be considered carefully.
Pregnancy, has not been studied. Use only if the benefit justifies potential risk to foetus.
Lactation, not known whether excreted in human milk. Should not be administered to nursing mothers. Breast feeding should be interrupted for 48 hours after administration.
Overdosage: No cases reported. Overdose of drug and/or light may result in the possibility of severe vision decrease. Drug overdose may also result in prolongation of photosensitive period.
Precautions: Patients will become photosensitive for 48 hours after infusion, during which time exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor lights should be avoided. If patients have to go outdoors during this time, protective clothing and dark glasses must be worn. Ambient indoor light is safe and patients should be encouraged to expose their skin to such light as it will help eliminate the drug quickly through the skin. Patients who experience a severe decrease of vision within one week after treatment should not be re-treated (see SPC). Patients should not drive or use machines for as long as transient visual disturbances persist.
Drug interactions: No specific interaction studies have been conducted in humans. Concomitant use of other photosensitising agents (eg, tetracyclines, sulphonamides, hypoglycaemic agents, phenothiazines, thiazide diuretics and griseofulvin) could increase the potential for photosensitivity reactions.
Side effects: In placebo controlled trials, common adverse effects included abnormal vision (such as blurry, hazy, fuzzy vision or flashes of light), decreased vision, visual field defects (such as grey or dark haloes, scotoma and black spots), nausea, photosensitivity reaction, back pain during infusion, asthenia, pruritus and hypercholesterolaemia. Common injection site adverse effects included pain, oedema, extravasation, inflammation, haemorrhage and hypersensitivity. See SPC for uncommon effects.
Net price: 15mg £850.
Supplier: Ciba Vision (UK), Flanders Road, Hedge End, Southampton SO30 2LG.
Legal class: POM.