Zuellig Pharma
Concise Prescribing Info
Neovascular (wet) age-related macular degeneration (AMD). Visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (branch or central RVO), choroidal neovascularization (CNV), & CNV secondary to pathologic myopia (PM). Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) & proliferative diabetic retinopathy (PDR).
Dosage/Direction for Use
0.5 mg as a single intravitreal inj. Interval between 2 doses should not be <1 mth. Wet AMD, DME, moderately severe to severe NPDR or PDR, macular edema secondary to RVO, CNV, CNV secondary to PM Initially 1 inj/mth until max visual acuity is achieved &/or there are no signs of disease activity. If patients are being treated according to a treat-&-extend regimen eg, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. Extend treatment interval by 2 wk at a time for wet AMD & central RVO (CRVO), or by 1 mth at a time for DME & branch RVO (BRVO). If disease activity recurs, the treatment interval should be shortened accordingly. Visual impairment due to CNV secondary to PM 1 or 2 inj during the 1st yr. Some patients may need more frequent treatment. Laser photocoagulation in DME, BRVO When given on the same day, administer at least 30 min after laser photocoagulation.
Hypersensitivity. Active or suspected ocular or periocular infections, active intraocular inflammation.
Special Precautions
Monitor IOP & perfusion of the optic nerve head. Potential risk of arterial thromboembolic events. Patients w/ known risk factors for stroke (history of prior stroke or transient ischemic attack). Potential for immunogenicity. Patients w/ active systemic infections or concurrent eye conditions eg, retinal detachment or macular hole. May affect ability to drive or operate machinery. Pregnancy (wait at least 3 mth after last dose of ranibizumab before becoming pregnant) & lactation. Childn & adolescent.
Adverse Reactions
Nasopharyngitis; headache, intraocular inflammation, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, ocular hyperemia, eye pruritus; arthralgia; increased IOP. Influenza, UTI (DME population only); anemia; anxiety; stroke; retinal degeneration, retinal 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 hemorrhage, eye hemorrhage, conjunctivitis, allergic conjunctivitis, eye discharge, photopsia, photophobia, ocular discomfort, eyelid edema & pain, conjunctival hyperemia; cough; nausea; allergic reactions (eg, rash, urticaria, pruritus, erythema).
ATC Classification
S01LA04 - ranibizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Lucentis inj 10 mg/mL
0.23 mL x 1's
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