IntravitrealNeovascular (wet) age-related macular degenerationAdult: 6 mg once monthly for the 1st 3 doses; followed by 6 mg once every 2-3 months, according to response. In patients without disease activity: May consider treatment interval of every 3 months. In patients with disease activity: May consider treatment interval of every 2 months. May further adjust treatment interval based on disease activity. Instruction prior to administration may vary among individual products and between countries (refer to specific product guidelines).
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Active or suspected ocular or periocular infections, active intraocular inflammation.
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Patient with poorly controlled glaucoma, risk factors for retinal pigment epithelial tear (e.g. large and/or high pigment epithelial retinal detachment); retinal detachment or macular hole; history of stroke, TIA or MI within the last 3 months; history of intraocular inflammation and/or retinal vascular occlusion (within 12 months before the 1st inj). Females. Japanese ancestry.
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Significant: Endophthalmitis, retinal detachment, intraocular inflammation (including retinal vasculitis or retinal vascular occlusion), traumatic cataract, acute and sustained increases in intraocular pressure, antibody development, non-ocular haemorrhages; risk of arterial thromboembolic events (e.g. stroke, MI).
Eye disorders: Reduced visual acuity, vitreous floaters, conjunctival haemorrhage, uveitis, iritis, vitreous detachment, retinal tear, eye pain, blurred vision, conjunctivitis, retinal pigment epithelial tear, corneal abrasion, punctate keratitis.
Immune system disorders: Hypersensitivity (e.g. rash, pruritus, urticaria, erythema).
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This drug may cause temporary visual disturbances, if affected, do not drive or operate machinery.
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Monitor intraocular pressure using tonometry and optic nerve head perfusion immediately after administration. Evaluate for signs and symptoms of eye inflammation including endophthalmitis (e.g. eye pain or redness, photophobia, blurred vision), retinal detachment or thromboembolic events.
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Symptoms: Increased intraocular pressure. Management: Monitor and initiate appropriate treatment.
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Description:
Mechanism of Action: Brolucizumab, a recombinant humanised monoclonal antibody vascular endothelial growth factor (VEGF) inhibitor, binds with high affinity to 3 major isoforms of VEGF-A. This results in suppressed endothelial cell proliferation, reduced neovascularisation, and decreased vascular permeability.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 24 hours (free brolucizumab).
Metabolism: Expected to be metabolised via proteolysis (free brolucizumab).
Excretion: Elimination half-life: 4.4 ± 2 days.
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Store between 2-8°C. Do not freeze. Protect from light. Unopened vial or pre-filled syringe may be stored below 25°C for up to 24 hours prior to use.
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S01LA06 - brolucizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
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Anon. Brolucizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/02/2022. Beovu 120 mg/mL Solution for Injection in Pre-Filled Syringe; Beovu 120 mg/mL Solution for Injection (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 11/02/2022. Beovu Injection Solution (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/07/2021. Brolucizumab (Beovu): Risk of Intraocular Inflammation and Retinal Vascular Occlusion Increased with Short Dosing Intervals. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency. Accessed 11/02/2022. Buckingham R (ed). Brolucizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/07/2021. Joint Formulary Committee. Brolucizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/02/2022. Pagenax 120 mg/mL Solution for Injection (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/07/2021.
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