Company: Bayer Healthcare.
Legal category: Hospital. Sport permitted.
Active ingredient: Aflibercept 40mg/ml.
Description: Solution for injection in vial.
Presentation: 100μl (50μl usable amount) per vial. Price available on request.
Indications: Treatment of neovascular (wet) age-related macular degeneration.
Pharmacology: Aflibercept is a recombinant fusion protein consisting of portions of human vascular endothelial growth factor (VEGF) receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1. It acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) with higher affinity than their natural receptors. Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability. PlGF can synergize with VEGF-A in these processes, and is also known to promote leucocyte infiltration and vascular inflammation.
Dosage: Adult: One intravitreal injection (50μl) per month for three consecutive doses, followed by one injection every two months; no requirement for monitoring between injections. After 12 months of treatment, treatment interval may be extended based on visual and anatomic outcomes. Schedule for monitoring may be more frequent than the schedule of injections. Elderly: As per adults. Children: Safety and efficacy not established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active or suspected ocular or periocular infection. Active severe intraocular inflammation. Pregnancy, lactation (asses risk/benefit).
Special precautions: Intravitreal injection only by experienced physicians. Instruct patients to report immediately any symptoms of endophthalmitis or intraocular inflammation. Poorly controlled glaucoma (do not use while intraocular pressure (IOP) ≥30mmHg); monitor IOP and perfusion of the optic nerve head. Non-ocular haemorrhages and arterial thromboembolic events reported following intravitreal injection of VEGF inhibitors. Concurrent administration to both eyes (not studied). Risk factors for retinal pigment epithelial tears. With-hold treatment if rhegmatogenous retinal detachment, or stage 3 or 4 macular holes occurs. If retinal break occurs, suspend treatment until break is adequately repaired. Withhold dose until next scheduled treatment in event of: Decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50% of total lesion area; performed or planned intraocular surgery within previous or next 28 days. Driving/using machines (temporary visual disturbance).
Drug interactions: Verteporfin photodynamic therapy (not studied).
Adverse drug reactions: Conjunctival haemorrhage, eye pain, retinal detachment, retinal pigment epithelium tear, detachment of the retinal pigment epithelium, retinal degeneration, cataract, cataract nuclear, cataract subcapsular, corneal abrasion, increased IOP, blurred vision, vitreous floaters, corneal oedema, vitreous detachment, injection site pain, foreign body sensation in eyes, increased lacrimation, eyelid oedema, injection site haemorrhage, conjunctival hyperaemia, ocular hyperaemia.
Full prescribing information and references available from Bayer Healthcare. Telephone: (01) 2999313.