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Yesafili

Yesafili

aflibercept

Manufacturer:

Biocon

Distributor:

Duopharma Marketing
Concise Prescribing Info
Contents
Aflibercept
Indications/Uses
Neovascular (wet) age-related macular degeneration (AMD). Visual impairment due to macular oedema secondary to retinal vein occlusion (branch/central RVO); diabetic macular oedema (DME); myopic choroidal neovascularisation (CNV).
Dosage/Direction for Use
Intravitreal inj 2 mg (equiv to 0.05 mL). Wet MD Initially 1 inj/mth for 3 consecutive doses. Treatment interval: Extended to 2 mth, may be maintained at 2 mth or further using treat-&-extend dosing regimen. Macular oedema secondary to RVO (branch/central RVO) After initial inj, treatment is given mthly w/ intervals not shorter than 1 mth between 2 doses. Continue until max visual acuity is achieved &/or no signs of disease activity. May then be continued w/ treat-&-extend regimen w/ gradual increased treatment intervals to maintain stable visual &/or anatomic outcomes. DME Initially 1 inj/mth for 5 consecutive doses, followed by 1 inj every 2 mth. After 1st 12 mth, treatment interval may be extended by 2-wk increments to maintain stable visual &/or anatomic outcomes. Myopic CNV 2 mg (equiv to 0.05 mL) as single inj, may administer additional doses if disease persists.
Contraindications
Hypersensitivity. Active or suspected ocular or periocular infection; active severe intraocular inflammation.
Special Precautions
Not recommended in patients w/ clinical signs of irreversible ischaemic visual function loss. Endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear & iatrogenic traumatic cataract. Non-ocular haemorrhages & arterial thromboembolic events. Patients w/ poorly controlled glaucoma; history of stroke, transient ischaemic attacks or MI w/in last 6 mth; active systemic infections or concurrent eye conditions eg, retinal detachment or macular hole; risk factors for retinal pigment epithelial tears; DME due to diabetes. Withhold treatment in patients w/ rhegmatogenous retinal detachment or stage 3 or 4 macular holes; in the event of a retinal break until the break is adequately repaired; decrease in best-corrected visual acuity of ≥30 letters compared w/ last assessment; subretinal haemorrhage involving the centre of fovea or if haemorrhage size is ≥50% of total lesion area; performed or planned intraocular surgery w/in previous or next 28 days. Increased risk of adverse events w/ bilateral treatment. Diabetic patients w/ uncontrolled HTN; non-Asian patients, patients w/ extrafoveal lesions w/ myopic CNV. Immunogenicity. Monitor patients during the wk following inj to permit early treatment if infection occurs. Concomitant use of other anti-VEGF. May affect ability to drive & use machines. Women of childbearing should use effective contraception during & for at least 3 mth after last dose. Not to be used during pregnancy. Not recommended during lactation. Elderly >75 yr w/ DME.
Adverse Reactions
Reduced visual acuity, retinal & conjunctival haemorrhage, eye pain. Retinal pigment epithelial tear & detachment, retinal degeneration, vitreous haemorrhage,  floaters & detachment, cataract, cortical/nuclear/subcapsular cataract, corneal erosion & abrasion, increased IOP & lacrimation, blurred vision, inj site pain & haemorrhage, foreign body sensation in eyes, eyelid oedema, punctate keratitis, conjunctival & ocular hyperaemia.
MIMS Class
Other Eye Preparations
ATC Classification
S01LA05 - aflibercept ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Presentation/Packing
Form
Yesafili soln for inj (vial) 40 mg/mL
Packing/Price
1's
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