Lucentis

Lucentis

ranibizumab

Manufacturer:

Novartis

Distributor:

DCH Auriga

Marketer:

IQVIA
Concise Prescribing Info
Contents
Ranibizumab
Indications/Uses
Adults w/ 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). Preterm infants w/ retinopathy of prematurity (ROP).
Dosage/Direction for Use
Intravitreal Adult Recommended dose: 0.5 mg as single inj. Interval between 2 doses inj into the same eye 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. May be extended by 2 wk at time for wet AMD & central RVO or by 1 mth at time for DME & branch RVO when treated w/ treat-&-extend regimen. 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 & branch RVO When given on the same day, administer at least 30 min after laser photocoagulation. Pre-term infant ROP Initially 0.2 mg as single inj. May be given bilaterally on the same day. Interval between 2 doses inj into the same eye should not be shorter than 1 mth.
Contraindications
Hypersensitivity. Patients w/ active or suspected ocular or periocular infections; active intraocular inflammation.
Special Precautions
Endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear & iatrogenic traumatic cataract. Transient increases in IOP w/in 60 min of inj & sustained IOP increases. Potential risk of arterial thromboembolic events; immunogenicity. Bilateral treatment. Patients w/ known risk factors for stroke including history of prior stroke or transient ischemic attack; active systemic infections or concurrent eye conditions eg, retinal detachment or macular hole. Monitor patients during the wk following inj to permit early treatment if an infection occurs; IOP & optic nerve head perfusion. May affect ability to drive or use machines. Females of reproductive potential should use effective contraception during treatment & wait at least 3 mth after the last dose before conceiving a child. Not to be used during pregnancy & breastfeeding. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Nasopharyngitis; headache; intraocular inflammation, vitritis, vitreous detachment, retinal & conjunctival haemorrhage, visual disturbance, eye pain, irritation or pruritus, vitreous floaters, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, ocular hyperemia; arthralgia; increased IOP. Flu, UTI (DME population only); anaemia; anxiety; stroke; retinal degeneration, disorder, detachment or tear, retinal pigment epithelium detachment & tear, reduced visual acuity, vitreous haemorrhage & disorder, uveitis, iritis, iridocyclitis, cataract, subcapsular cataract, posterior cap opacification, punctate keratitis, corneal abrasion, anterior chamber flare, blurred vision, inj site haemorrhage, eye hemorrhage & discharge, conjunctivitis, allergic conjunctivitis, photopsia, photophobia, ocular discomfort, eyelid oedema & pain, conjunctival hyperemia; cough; nausea; allergic reactions eg, rash, urticaria, pruritus, erythema.
MIMS Class
Other Eye Preparations
ATC Classification
S01LA04 - ranibizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Presentation/Packing
Form
Lucentis soln for inj 10 mg/mL
Packing/Price
0.23 mL x 1's
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