Vabysmo

Neovascular (wet) age-related macular degeneration (nAMD). Diabetic macular edema (DME). Macular edema secondary to retinal vein occlusion [branch retinal vein occlusion (BRVO) & central vein occlusion (CRVO)].

Intravitreal nAMD 6 mg (0.05 mL) every 4 wk (approx every 28±7 days, mthly) for the 1st 4 doses, followed by 6 mg (0.05 mL) at a dosing interval of up to every 16 wk (4 mth). Dosing interval should be based on individual patient's retinal thickness [central subfield thickness (CST)] &/or visual acuity. Some patients may be dosed as frequently as every 4 wk (approx every 28±7 days, mthly). DME 6 mg (0.05 mL) every 4 wk (approx every 28±7 days, mthly) for the 1st 4 doses. Thereafter, treatment may be individualised using treat-&-extend approach. Dosing interval may be extended up to max of every 16 wk (4 mth) in increments of up to 4 wk depending on CST &/or visual acuity. Macular edema secondary to retinal vein occlusion (BRVO & CRVO) 6 mg (0.05 mL) every 4 wk (approx every 28±7 days, or once a mth); ≥3 consecutive, mthly inj may be needed, until max visual acuity is achieved &/or no signs of disease activity are seen. Thereafter, treatment may be individualised using a treat-&-extend approach. Dosing interval may be extended based on CST &/or visual acuity.

Hypersensitivity. Patients w/ ocular or periocular infections; active intraocular inflammation.

Each vial should only be used for treatment of a single eye. Monitor for elevation in IOP immediately following intravitreal inj. Intravitreal inj-related reactions eg, endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear & iatrogenic traumatic cataract. Caution in patients w/ poorly controlled glaucoma (do not inj while IOP ≥30 mmHg); risk factors for retinal pigment epithelial tears. Monitor IOP & perfusion of optic nerve head &/or vision & manage appropriately. Reports of arterial thromboembolic events. Possible immunological reaction. Safety & efficacy of administration in both eyes have not been studied. 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/ the last assessment of visual acuity; performed or planned intraocular surgery w/in the previous or next 28 days. Limited experience in treatment of DME patients w/ HbA1c >10%, those w/ high-risk proliferative diabetic retinopathy, or nAMD-, DME-, BRVO- & CRVO-patients w/ active systemic infections. No experience in treatment of diabetic patients w/ uncontrolled HTN. No data on concomitant use w/ anti-VEGF medicinal products in the same eye. May have minor influence on ability to drive & use machines. Safety & efficacy in patients w/ hepatic impairment has not been studied. Women of childbearing potential should use effective contraception during treatment & for at least 3 mth following last dose. Safe use during labor & delivery has not been established. Should not be used during pregnancy unless treatment is required due to clinical condition of the woman. Caution when administered to a nursing woman. Safety & efficacy in ped patients have not been established.

Cataract, conjunctival hemorrhage, vitreous detachment, increased IOP, vitreous opacities, retinal pigment epithelial tear (nAMD only), eye pain.

Other Eye Preparations

S01LA09 - faricimab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.

Rx