Pagenax

Pagenax

brolucizumab

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Brolucizumab
Indications/Uses
Neovascular (wet) age-related macular degeneration (AMD). Visual impairment due to diabetic macular oedema (DME).
Dosage/Direction for Use
Wet AMD 6 mg intravitreal inj every 4 wk for 1st 3 doses, then individualize treatment intervals based on disease activity. DME 6 mg intravitreal inj every 6 wk for 1st 5 doses, then individualize treatment intervals based on disease activity. Patient w/o disease activity Treatment every 12 wk, patient w/ disease activity Treatment every 8 wk.
Contraindications
Hypersensitivity. Active or suspected ocular/periocular infections; active intraocular inflammation.
Special Precautions
Discontinue use in patients w/ rhegmatogenous retinal detachment, or stage 3 or 4 macular holes. Not to inj while IOP is ≥30 mmHg. Endophthalmitis; intraocular inflammation including retinal vasculitis &/or vascular occlusion; traumatic cataract; retinal detachment & tear. Risk factors for retinal pigment epithelial tears. History of stroke, transient ischaemic attacks or MI w/in last 3 mth; poorly controlled glaucoma; diabetic patients w/ HbA1c >10% or proliferative diabetic retinopathy; uncontrolled HTN. Withhold & not to be resumed earlier than the next scheduled treatment in case of decrease in best-corrected visual acuity of ≥30 letters compared w/ last visual acuity assessment; retinal break; subretinal haemorrhage involving centre of fovea or if size of haemorrhage is ≥50% of total lesion area; performed or planned intraocular surgery w/in previous or next 28 days. Immunogenicity. Bilateral treatment. Monitor & manage for increased IOP & optic nerve head perfusion. Japanese patients. Not to be used concurrently w/ other systemic or ocular anti-VEGF medicinal products. May affect ability to drive or use machines. Hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 1 mth after last dose. Not to be used during pregnancy. Not recommended during lactation & for at least 1 mth after last dose. Childn & adolescents <18 yr.
Adverse Reactions
Hypersensitivity; reduced visual acuity, retinal haemorrhage, tear & pigment epithelial tear, uveitis, iritis, vitreous detachment & floaters, cataract, conjunctival haemorrhage, eye pain, increased IOP, conjunctivitis, 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
Pagenax intraocular inj 120 mg/mL
Packing/Price
1's
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