6 mg (0.05 mL soln) by intravitreal inj every 4 wk for the 1st 4 doses. nAMD Assess disease by wk 20 &/or 24, & individualised treatment. Patient w/o disease activity Consider every 16 wk administration. Patient w/ disease activity Consider every 8 or 12 wk treatment. DMO After initial 4 doses, individualised treatment using treat-&-extend approach. Dosing interval may be extended to every 16 wk, w/ extensions in increments of up to 4 wk.
Monitor for IOP elevation immediately following inj. Risk of intravitreal inj-related reactions eg, endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment & retinal tear; transient IOP increases. Reports of sustained (present at ≥2 consecutive visits) IOP increases >21 mmHg; systemic adverse events including arterial thromboembolic events. Do not inj while IOP ≥30 mmHg. Potential for immunogenicity. W/hold treatment in patients w/ rhegmatogenous retinal detachment, stage 3 or 4 macular holes, retinal break; treatment-related decrease in best corrected visual acuity of ≥30 letters compared w/ last assessment; performed or planned intraocular surgery w/in previous or next 28 days. Caution in patients w/ poorly controlled glaucoma; risk factors for retinal pigment epithelial tears. Populations w/ limited data: Patients w/ history of stroke or transient ischemic attack or MI; nAMD patients w/ total lesion size >9 disc areas on fundus fluorescein angiography; DMO patients w/ HbA1c >10%; patients w/ high-risk proliferative diabetic retinopathy; nAMD & DMO patients w/ active systemic infections; diabetic patients w/ uncontrolled HTN. Safety & efficacy of bilateral treatment have not been studied. Do not administer concurrently w/ other anti-VEGF medicinal products (systemic or ocular). Minor influence on ability to drive & use machines. Female patients of childbearing potential should use effective contraception during treatment & for at least 3 mth following the last inj. As a precautionary measure it is preferable to avoid use of Vabysmo during pregnancy unless potential benefit outweighs potential risk to the foetus. Not recommended during breast-feeding. Safety & efficacy in childn & adolescents have not been established.
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