Concise Prescribing Info
Neovascular (wet) age-related macular degeneration (AMD); proliferative diabetic retinopathy (PDR); visual impairment due to diabetic macular oedema (DME), macular oedema secondary to retinal vein occlusion (RVO) & choroidal neovascularization (CNV); retinopathy of prematurity (ROP) w/ zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or aggressive posterior (AP-ROP) disease in preterm infants.
Dosage/Direction for Use
0.5 mg as single intravitreal inj w/ at least 4 wk interval between 2 doses, then monitor for visual acuity mthly. Wet AMD, PDR, DME & RVO Initially ≥3 consecutive mthly inj may be needed. Thereafter, monitoring & treatment intervals should be based on disease activity. CNV secondary to pathologic myopia 1 or 2 inj during 1st year. Accentrix & laser photocoagulation in DME or branch RVO Administered concomitantly; when given on same day, administer at least 30 min after laser photocoagulation. ROP in preterm infant 0.2 mg as single intravitreal inj w/ at least 4 wk interval between 2 doses. Max: 3 inj/eye w/in 6 mth.
Hypersensitivity. Active or suspected ocular/periocular infections; active intraocular inflammation.
Special Precautions
Discontinue use if rhegmatogenous retinal detachment, or stage 3 or 4 macular holes occur. Endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear & iatrogenic traumatic cataract. Active systemic infections or concurrent eye conditions eg, retinal detachment or macular hole. Non-ocular haemorrhages & arterial thromboembolic events following intravitreal use of VEGF inhibitors; prior history of stroke or transient ischemic attack. Risk factors for retinal pigment epithelial tears. Increased risk of adverse events w/ bilateral treatment. Diabetic patients, uncontrolled HTN; patients w/ RVO presenting irreversible ischaemic visual function loss; previously undergone unsuccessful verteporfin photodynamic therapy treatment; PM subjects w/ extrafoveal lesions. Immunogenicity. Withhold & not to be resumed earlier than the next scheduled treatment in case of decrease in best-corrected visual acuity of ≥30 letters compared w/ last visual acuity assessment; IOP ≥30 mmHg; retinal break; subretinal haemorrhage involving centre of fovea or if size of haemorrhage is ≥50% of total lesion area; performed or planned intraocular surgery w/in previous or next 28 days. Monitor during the wk following inj to permit early treatment if infection occurs. Monitor & manage for increased IOP & optic nerve head perfusion. Not to be used concurrently w/ other anti-VEGF medicinal products. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended during lactation. Childn & adolescents <18 yr (for indications other than ROP). Elderly >75 yr w/ DME.
Adverse Reactions
Nasopharyngitis; headache; intraocular inflammation, vitritis, vitreous detachment & floaters, retinal & conjunctival hemorrhage, visual disturbance, eye pain, irritation & pruritus, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, ocular hyperemia; arthralgia; increased IOP. Flu, UTI; anemia; anxiety; stroke; retinal degeneration, disorder, detachment & tear; retinal pigment epithelium detachment & tear; reduced visual acuity; vitreous hemorrhage & disorder; uveitis, iritis, iridocyclitis, cataract, subcapsular cataract, posterior cap opacification, punctate keratitis, corneal abrasion, anterior chamber flare, blurred vision, inj site & eye hemorrhage; conjunctivitis, allergic conjunctivitis, eye discharge, photopsia, photophobia, ocular discomfort, eyelid edema & pain; conjunctival hyperemia; cough, nausea; allergic reactions.
MIMS Class
Other Eye Preparations
ATC Classification
S01LA04 - ranibizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Accentrix soln for inj 10 mg/mL
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