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Vabysmo

Vabysmo

faricimab

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Faricimab
Indications/Uses
Neovascular (wet) age-related macular degeneration (nAMD) in adults. Visual impairment due to diabetic macular oedema (DME) in adults. Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) in adults.
Dosage/Direction for Use
nAMD 6 mg (0.05 mL soln) by intravitreal inj every 4 wk (mthly) for the 1st 3 doses. Thereafter, assess disease activity based on anatomic &/or visual outcomes 16 &/or 20 wk after treatment initiation to individualise treatment. Consider treatment every 16 wk (4 mth) if w/o disease activity, & every 8 or 12 wk (2 or 3 mth) if w/ disease activity. Visual impairment due to DME & macular oedema secondary to RVO 6 mg (0.05 mL soln) by intravitreal inj every 4 wk (mthly); ≥3 consecutive mthly inj may be needed. Thereafter, individualise treatment using treat-&-extend approach. Dosing interval may be extended in increments of up to 4 wk based on anatomic &/or visual outcomes.
Contraindications
Hypersensitivity. Active or suspected ocular or periocular infections. Active intraocular inflammation.
Special Precautions
Monitor for IOP elevation immediately following intravitreal inj. Risk of intravitreal inj-related reactions eg, endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear, & iatrogenic traumatic cataract; transient IOP increases. Caution in patients w/ poorly controlled glaucoma; risk factors for retinal pigment epithelial tears. 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; IOP ≥30 mmHg; subretinal haemorrhage involving centre of fovea or if haemorrhage size is ≥50% of total lesion area; performed or planned intraocular surgery w/in previous or next 28 days. Safety & efficacy of bilateral treatment have not been studied. Reports of systemic adverse events including arterial thromboembolic events. Potential for immunogenicity. Concomitant use w/ other anti-VEGF. Limited experience in nAMD & RVO patients ≥85 yr, & DME patients w/ type I diabetes, patients w/ HbA1c >10%, patients w/ high-risk proliferative diabetic retinopathy, high BP (≥140/90 mmHg) & vascular disease, sustained dosing intervals shorter than every 8 wk, or nAMD, DME, & RVO patients w/ active systemic infections. No experience in diabetic or RVO patients w/ uncontrolled HTN & patients w/ RVO who have failed previous therapy. Should not be taken by patients w/ hypersensitivity to polysorbate. Minor influence on ability to drive & use machines. Women of childbearing potential should use effective contraception during treatment & for at least 3 mth following the last intravitreal inj. Do not use during pregnancy unless potential benefit outweighs potential risk to foetus. Do not use during breast-feeding. No relevant use in the paed population.
Adverse Reactions
Cataract, conjunctival haemorrhage, vitreous detachment, increased IOP, vitreous floaters, retinal pigment epithelial tear (nAMD only), eye pain.
Drug Interactions
Do not administer concurrently w/ other systemic or ocular anti-VEGF medicinal products.
MIMS Class
Other Eye Preparations
ATC Classification
S01LA09 - faricimab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Presentation/Packing
Form
Vabysmo soln for intravitreal inj 6 mg/0.05 mL
Packing/Price
1's
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