Pagenax

Pagenax

brolucizumab

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Brolucizumab
Indications/Uses
Adults w/ neovascular (wet) age-related macular degeneration (AMD) or visual impairment due to diabetic macular oedema (DME).
Dosage/Direction for Use
Intravitreal inj Wet AMD Recommended dose: 6 mg (0.05 mL) every 4 wk for 1st 3 doses. Alternatively, 6 mg (0.05 mL) inj every 6 wk for 1st 2 doses. Maintenance treatment: May individualize treatment intervals based on disease activity assessed at 16 wk (4 mth) or 12 wk (3 mth) after start of treatment. Patient w/o disease activity Consider treatment every 12 wk (3 mth). Patient w/ disease activity Consider treatment every 8 wk (2 mth) w/ interval of not less than every 8 wk (2 mth) between 2 doses. DME Recommended dose: 6 mg (0.05 mL) every 6 wk for 1st 5 doses. May individualize treatment intervals based on disease activity. Patient w/o disease activity Consider treatment every 12 wk (3 mth). After 12 mth treatment: Consider intervals up to 16 wk (4 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
Discontinue treatment in patients developing retinal vasculitis &/or retinal vascular occlusion, typically w/ intraocular inflammation; w/ rhegmatogenous retinal detachment or stage 3 or 4 macular holes. Withhold treatment in case of decrease in best-corrected visual acuity of ≥30 letters compared w/ last assessment; retinal break; subretinal haemorrhage involving center 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. Not to inj while IOP is ≥30 mmHg. Closely monitor patients experiencing intraocular inflammation at risk of developing retinal vasculitis &/or retinal vascular occlusion. Endophthalmitis, intraocular inflammation, traumatic cataract, retinal detachment & tear; non-ocular haemorrhages & arterial thromboembolic events. Transient increases in IOP w/in 30 min inj w/ vascular endothelial growth factor (VEGF) inhibitors. Bilateral treatment. Potential for immunogenicity; eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased number of small particles in vision or light sensitivity. Patients w/ poorly controlled glaucoma; risk factors for retinal pigment epithelial tears; history of stroke, transient ischemic attacks or MI w/in last 3 mth. Diabetic patients w/ HbA1c >10%, proliferative diabetic retinopathy, or uncontrolled HTN. Evaluate patient's medical history for hypersensitivity reactions prior to intravitreal procedure. Monitor & manage increased IOP & optic nerve head perfusion. Concomitant use w/ other systemic or ocular anti-VEGF medicinal products. May affect ability to drive & use machines due to possible temporary visual disturbances. Women of childbearing potential should use effective contraception during treatment & for at least 1 mth after last dose. Not to be used during pregnancy. Not recommended during lactation; not to start lactation for at least 1 mth after last dose. Childn & adolescents <18 yr.
Adverse Reactions
Hypersensitivity (including urticaria, rash, pruritus, erythema); reduced visual acuity, retinal & conjunctival haemorrhage, uveitis, iridocyclitis, iritis, retinal vascular occlusion, vitreous haemorrhage, detachment & floaters, retinal tear, cataract, 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
Pagenax soln for inj 120 mg/mL
Packing/Price
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
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in