EyeWorld Korea September 2013

See your success in the eyes of your patients De ning the standard of care in wet AMD * *Neovascular (wet) age-related macular degeneration (AMD) Note: Before prescribing, consult full prescribing information. Presentation : Ranibizumab. Each vial contains 2.3 mg of ranibizumab in 0.23 mL solution. Indications : Treatment of neovascular (wet) age-related macular degeneration (AMD) ◆ Treatment of visual impairment due to diabetic macular edema (DME) ◆ Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). Dosage : The recommended dose is 0.5 mg (0.05 mL) given as a single intravitreal injection. The interval between two doses should not be shorter than 1 month ◆ Patients should be monitored monthly for visual acuity ◆ Treatment is given monthly and continued until maximum visual acuity is achieved, con rmed by stable visual acuity for three consecutive monthly assessments performed while on Lucentis ® treatment. Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to wet AMD, DME or macular edema secondary to RVO and continued until stable visual acuity is reached again for three consecutive monthly assessments ◆ Lucentis and laser photocoagulation in DME: Lucentis has been used concomitantly with laser photocoagulation in clinical studies. When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be administered in patients who have received previous laser photocoagulation ◆ Lucentis must be administered by a quali ed ophthalmologist using aseptic techniques. Broad-spectrum topical microbicide and anaesthetic should be administered prior to the injection ◆ The patient should be instructed to self-administer antimicrobial drops four times daily for 3 days before and after each injection. •Not recommended in children and adolescents. Contraindications : Hypersensitivity to ranibizumab or to any of the excipients,patientswithactiveorsuspectedocularorperiocular infections, patients with active intraocular in“ammation. Precautions/Warnings : Intravitreous injections have been associated with endophthalmitis, intraocular in“ammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Therefore proper aseptic injection techniques must be used. Patients should be monitored during the week following the 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 the perfusion of the optic nerve head must be monitored and managed appropriately ◆ 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 0.5 mg compared to ranibizumab 0.3 mg or control, however, the di›erences were not statistically signi cant. Patients with known risk factors for stroke, including history of prior stroke or transient ischemic attack should be carefully evaluated by their physicians as to whether Lucentis treatment is appropriate and the bene t 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 active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole ◆ There is 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 not be used during pregnancy unless the expected bene t outweighs the potential risk to the fetus. 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 e›ective contraception recommended for women of child-bearing potential; breast-feeding not recommended ◆ Following treatment patients may develop transient visual disturbances that may interfere with their ability to drive or use machines. Patients should not drive or use machines as long as these symptoms persist. Interactions : No formal interaction studies have been performed. Adverse reactions : Very common adverse reactions are: intraocular in“ammation, vitritis, vitreous detachment, retinal hemorrhage, visual disturbance, eye pain, vitreous “oaters, conjunctival hemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperemia, eye pruritus, intraocular pressure increased, nasopharyngitis, headache, arthralgia ◆ Common adverse reactions are : retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous hemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opaci cation, punctuate keratitis, corneal abrasion, anterior chamber “are, vision blurred, injection site hemorrhage, eye hemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid edema, eyelid pain, conjunctival hyperemia, stroke, in“uenza, urinary tract infection * , anemia, anxiety, cough, nausea, allergic reactions (rash, pruritus, urticaria, erythema) ◆ Uncommon adverse reactions are : blindness, endophthalmitis, hypopyon, hyphema, keratopathy, iris adhesions, corneal deposits, corneal edema, corneal striae, injection site pain, injection site irritation, abnormal sensation in eye, eyelid irritation. ◆ Serious adverse events related to intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. (June 2011.SIN) * observed only in the DME population ©2013 Novartis Pharma AG 146885 August 2013 Lucentis Indications may vary from country to country. Physicians should refer to their National Prescribing Information. Novartis Pharma AG CH-4002 Basel, Switzerland