Agencia Lei Va Hong
Concise Prescribing Info
Neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to choroidal neovascularization (CNV); visual impairment due to macular oedema secondary to retinal vein occlusion (branch or central RVO).
Dosage/Direction for Use
0.5 mg (0.05 mL) as a single intravitreal inj. The interval between 2 doses injected into the same eye should be at least 4 wk. Initiate w/ 1 inj per mth until max visual acuity is achieved &/or there are no signs of disease activity. In wet AMD, DME, PDR & RVO, initially, ≥3 consecutive, mthly inj may be needed.
Hypersensitivity. Active or suspected ocular or periocular infections; active severe intraocular inflammation.
Special Precautions
Observe proper aseptic inj technique. Transient increases in IOP. Potential for immunogenicity. Do not co-administer w/ other anti-vascular endothelial growth factor (anti-VEGF) medicinal products (systemic or ocular). Withhold dose & do not resume treatment earlier than the next scheduled treatment in case of: a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared w/ the last assessment of visual acuity; ≥30 mmHg IOP; a retinal break; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50% of the total lesion area; performed or planned intraocular surgery w/in the previous or next 28 days. Retinal pigment epithelial tear. Discontinue in patients w/ rhegmatogenous retinal detachment or stage 3 or 4 macular holes. Patients w/ DME due to type I diabetes; previous treatment of intravitreal inj; active systemic infections; concurrent eye condition eg, retinal detachment or macular hole; diabetic patients w/ an HbA1c 108 mmol/mol (12%) & uncontrolled HTN; history of stroke or transient ischaemic attacks; patients w/ RVO presenting irreversible ischaemic visual function loss; patients w/ pathologic myopia (PM) who have previously undergone unsuccessful verteporfin photodynamic therapy; PM patients w/ extrafoveal lesions. Non-ocular haemorrhages & arterial thromboembolic events. May induce temporary visual disturbances. Women of childbearing potential. Pregnancy & lactation. Childn & adolescent <18 yr.
Adverse Reactions
Eye pain, ocular hyperaemia, increased IOP, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye & eye pruritus. Headache, nasopharyngitis, arthralgia.
ATC Classification
S01LA04 - ranibizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Lucentis soln for inj 10 mg/mL
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