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Beovu

Beovu

Manufacturer:

Alcon-Couvreur

Distributor:

Zuellig
/
Firma Chun Cheong

Marketer:

Novartis
Concise Prescribing Info
Contents
Brolucizumab
Indications/Uses
Neovascular (wet) age-related macular degeneration in adults.
Dosage/Direction for Use
Intravitreal Recommended dose: Administer 6 mg (0.05 mL soln) by inj every 4 wk (mthly) for the 1st 3 doses, may be individualised thereafter. Assess disease activity 16 wk (4 mth) after treatment initiation. Patient w/o disease activity Consider treatment every 12 wk (3 mth). Patient w/ disease activity Consider treatment every 8 wk (2 mth).
Contraindications
Hypersensitivity. Patients w/ active or suspected ocular or periocular infections; active intraocular inflammation.
Special Precautions
Always use proper aseptic inj techniques during administration. Risk of endophthalmitis, intraocular inflammation, traumatic cataract, retinal detachment, retinal vasculitis, &/or retinal vascular occlusion; systemic adverse events, including non-ocular haemorrhages & arterial thromboembolic events, following intravitreal inj. Transient increases in IOP w/in 30 min of intravitreal inj. Do not inj while IOP is ≥30 mmHg. Appropriately monitor & manage IOP & perfusion of the optic nerve head. Safety & efficacy of bilateral treatment have not been studied. Potential for immunogenicity. Dose should be withheld & treatment should not be resumed earlier than the next scheduled treatment in the event of a decrease in best-corrected visual acuity of ≥30 letters compared w/ the last assessment of visual acuity; 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. Should be discontinued in subjects w/ rhegmatogenous retinal detachment or stage 3 or 4 macular holes. Should not be administered concurrently w/ other anti-VEGF medicinal products (systemic or ocular). Patients w/ poorly controlled glaucoma. Patients w/ risk factors for retinal pigment epithelial tears. Minor influence on the ability to drive & use machines. Women of childbearing potential should use effective contraception during treatment & for at least 1 mth after the last dose when stopping treatment. Should not be used during pregnancy. Not recommended during breast-feeding; breast-feeding should not be started for at least 1 mth after the last dose when stopping treatment. Childn & adolescents <18 yr.
Adverse Reactions
Hypersensitivity (including urticaria, rash, pruritus, erythema); reduced visual acuity, retinal haemorrhage, uveitis, iritis, vitreous detachment, retinal tear, cataract, conjunctival haemorrhage, vitreous floaters, eye pain, increased IOP, conjunctivitis, retinal pigment epithelial tear, vision blurred, corneal abrasion, punctate keratitis.
ATC Classification
S01LA06 - brolucizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Presentation/Packing
Form
Beovu soln for inj in pre-filled syringe 6 mg/0.05 mL
Packing/Price
1's
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