Beovu

Beovu

brolucizumab

Manufacturer:

Alcon-Couvreur

Distributor:

Zuellig
/
Firma Chun Cheong

Marketer:

Novartis
Concise Prescribing Info
Contents
Brolucizumab
Indications/Uses
Neovascular (wet) age-related macular degeneration (AMD) in adults. Visual impairment due to diabetic macular oedema (DME) in adults.
Dosage/Direction for Use
Intravitreal inj Wet AMD Administer 6 mg (0.05 mL soln) 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). DME Administer 6 mg (0.05 mL soln) every 6 wk for the 1st 5 doses, may be individualised thereafter based on disease activity. 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
Monitor for IOP elevation immediately following intravitreal inj. Always use proper aseptic inj techniques during administration. Risk of endophthalmitis, intraocular inflammation, traumatic cataract, retinal detachment, retinal tear, retinal vasculitis, &/or retinal vascular occlusion. Interval between 2 Beovu doses during maintenance treatment should not be <8 wk. Transient increases in IOP w/in 30 min of intravitreal inj. Do not inj while IOP is ≥30 mmHg. 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. Discontinue treatment in subjects w/ rhegmatogenous retinal detachment or stage 3 or 4 macular holes. Do not administer concurrently w/ other anti-VEGF medicinal products (systemic or ocular). Caution in patients w/ poorly controlled glaucoma; risk factors for retinal pigment epithelial tears; history of stroke, transient ischaemic attacks or MI w/in the last 3 mth. Limited experience in diabetic patients w/ HbA1c >10% or proliferative diabetic retinopathy. No experience in diabetic patients w/ uncontrolled HTN. 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. Do not use during pregnancy unless the potential benefit outweighs the potential risk to the foetus. Not recommended during breast-feeding. Do not start breast-feeding for at least 1 mth after the last dose when stopping treatment. Safety & efficacy in childn & adolescents <18 yr have not been established.
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, blurred vision, corneal abrasion, punctate keratitis.
MIMS Class
Other Eye Preparations
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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