Concise Prescribing Info
Neovascular (wet) age-related macular degeneration (AMD); proliferative diabetic retinopathy (PDR); visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO) & choroidal neovascularisation (CNV).
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 PM 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.
Hypersensitivity. Active or suspected ocular/periocular infections; active intraocular inflammation.
Special Precautions
Endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear & iatrogenic traumatic cataract. Arterial thromboembolic events following intravitreal use of VEGF inhibitors; known risk factors for stroke including history of prior stroke or transient ischemic attack; immunogenicity. Active systemic infections or concurrent eye conditions eg, retinal detachment or macular hole. Increased risk of adverse events w/ bilateral treatment. Monitor during the wk following inj to permit early treatment if infection occurs. Monitor & manage for increased IOP & optic nerve head perfusion. May affect ability to drive or use machines. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended in lactation. Not recommended in childn & adolescents.
Adverse Reactions
Intraocular inflammation, vitritis, vitreous detachment & floaters, retinal & conjunctival hemorrhage, visual disturbance; eye pain, irritation & pruritus; foreign body sensation in eyes, increased lacrimation & IOP, blepharitis, dry eye, ocular hyperemia, nasopharyngitis, headache, arthralgia. 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, punctuate 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, stroke, influenza, UTI, anemia, anxiety, 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 inj 10 mg/mL
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