PU Conference Series: Euretina 2018

Selectively target VEGF-A with Lucentis ® – specifically developed for ocular use. 1,3 † Selectively targets VEGF-A isoforms. 1 Non-clinical description of mode of action. Not intended to imply a clinical benefit. PRECISE † DESIGNED FOR THE EYE 1–5

NEW

nAMD

DME

BRVO CRVO

mCNV other CNV

BRVO, branch retinal vein occlusion; CNV, choroidal neovascularisation; CRVO, central retinal vein occlusion; DME, diabetic macular oedema; mCNV, myopic choroidal neovascularisation; nAMD, neovascular age-related macular degeneration; VEGF, vascular endothelial growth factor.

PBS Information: Authority required for the treatment of wet AMD, DME, BRVO and CRVO. Refer to PBS Schedule for full Authority information. This product is not PBS listed for the treatment of CNV secondary to PM or to causes other than wet AMD. Before prescribing, please review full Product Information available from www.novartis.com.au/products/healthcare-professionals Indication: Treatment of neovascular (wet) age-related macular degeneration (AMD). The treatment of visual impairment due to choroidal neovascularisation. Treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM). Treatment of visual impairment due to diabetic macular oedema (DME). Treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO). Dosage and administration: Complex dosage and administration – see full PI before prescribing. Contraindications: Hypersensitivity to product components, active or suspected ocular or periocular infections active intraocular inflammation. Precautions: Intravitreal injections have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear, iatrogenic traumatic cataract and increased intraocular pressure. Proper aseptic injection techniques must be used. Review patients during the week following injection to permit early treatment if an infection occurs. Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis. Sustained IOP increases have also been reported. Intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately. Patients should be reviewed for IOP rise preinjection and 60 minutes post-injection. The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of an intraocular pressure of ≥30 mmHg. Bilateral use: limited data do not suggest an increased risk of systemic adverse events compared with unilateral treatment. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. A numerically higher stroke rate was observed in patients treated with ranibizumab 0.5mg compared to ranibizumab 0.3mg or control, however, the differences were not statistically significant. Patients with known risk factors for stroke, including history of prior stroke or transient ischaemic attack, should be carefully evaluated by their physicians as to whether Lucentis treatment is appropriate and the benefit outweighs the potential risk. As with all therapeutic proteins, there is a potential for immunogenicity with Lucentis. Lucentis has not been studied in patients with concurrent eye conditions such as retinal detachment or macular hole. No formal interaction studies have been performed. Limited experience with treatment of patients with prior episodes of RVO and of patients with ischemic branch RVO (BRVO) and central RVO (CRVO). In patients with RVO presenting with clinical signs of irreversible ischemic visual function loss, treatment is not recommended. Should be used with caution in women of child bearing potential in general, and during pregnancy in particular. For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child; use of effective contraception is recommended for women of childbearing potential; breastfeeding is not recommended. Lucentis is not recommended for use in children and adolescents Patients who experience temporary visual disturbances following treatment must not drive or use machines until these subside. Adverse effects: Very common (≥10%): Intraocular inflammation, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus, intraocular pressure increased, nasopharyngitis, headache, arthralgia. Common (1 to 10%): Retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous haemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, vision blurred, injection site haemorrhage, eye haemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid edema, eyelid pain, conjunctival hyperaemia, stroke, influenza, urinary tract infection*, anaemia, anxiety, cough, nausea, allergic reactions (rash, pruritus, urticaria, erythema). Uncommon (0.1 to 1%): Blindness, endophthalmitis, hypopyon, hyphaema, keratopathy, iris adhesions, corneal deposits, corneal oedema, corneal striae, injection site pain, injection site irritation, abnormal sensation in eye, eyelid irritation. Serious adverse events related to intravitreal injections include endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. *Observed only in the DME population. Based on TGA approved Product Information dated 22 August 2017 (luc220817m). *Please note changes to Product Information in italics. References: 1. Lucentis ® Product Information. August 2017. 2. Ferrara N, Adamis AP. Nat Rev Drug Discov 2016; 15 (6): 385–403. 3. Steinbrook R. N Engl J Med 2006; 355: 1409–1412. 4. Mordenti J et al. Toxicol Pathol 1999; 27 (5): 536–544. 5. Gaudreault J et al. Retina 2007; 27 (9): 1260–1266. Novartis Pharmaceuticals Australia Pty Limited. ABN 18 004 244 160.54 Waterloo Road, Macquarie Park, NSW 2113. ® Registered Trademark. AU-7316. McCann Health NOLU14800M/PUCS. September 2018.

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