Pagenax

Pagenax

brolucizumab

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Brolucizumab
Indications/Uses
Neovascular (wet) age-related macular degeneration (AMD).
Dosage/Direction for Use
Recommended dose: 6 mg (0.05 mL) intravitreal inj every 4 wk (mthly) for the first 3 doses, then every 12 wk (3 mth) thereafter. May individualize treatment intervals based on disease activity as assessed by visual acuity &/or anatomical parameters. Treatment interval could be as frequent as every 8 wk (2 mth).
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. Carefully evaluate patient's medical history for hypersensitivity reactions prior to procedure. Endophthalmitis & retinal detachment; retinal vasculitis &/or vascular occlusion; risk factors for retinal pigment epithelial tears. History of stroke, transient ischaemic attacks or MI w/in the last 3 mth. Monitor & manage IOP & optic nerve head perfusion. Bilateral treatment. Immunogenicity. Not to be administered concurrently w/ other anti-VEGF medicinal products (systemic or ocular). W/hold dose & do not resume earlier than the next scheduled treatment in the event of decrease in best corrected visual acuity (BCVA) of ≥30 letters compared w/ the last assessment of visual acuity; retinal break; 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. May experience temporary visual disturbances & should be advised not to drive or use machinery until visual function has recovered sufficiently. Females of reproductive potential should use effective contraception during treatment & for at least 1 mth after the last dose. Not to be used during pregnancy. Breastfeeding is not recommended during treatment & for at least 1 mth after the last dose. Ped patients (<18 yr).
Adverse Reactions
Hypersensitivity (eg, urticaria, rash, pruritus, erythema); reduced visual acuity, retinal & conjunctival haemorrhage, uveitis, iritis, vitreous detachment, retinal tear, retinal pigment epithelial tear, cataract, vitreous floaters, 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
(vial) 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in