Opuviz®

GoodRx

Aflibercept-yszy · intravitreal injection

Injections & Implants

Indication

OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR)

Contraindications

Ocular or periocular infections Active intraocular inflammation Hypersensitivity.

Available Forms

2 mg, 0.05 mL, 40 mg/mL vial

Mechanism of Action

Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability.

Dosage

Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for OPUVIZ is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months).

Warnings & Precautions

Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion: Intravitreal injections, including those with aflibercept products, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion . Proper aseptic injection technique must always be used when administering OPUVIZ.
Increase in Intraocular Pressure: Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with aflibercept products . Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors.
Thromboembolic Events: There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Common Side Effects

The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

Pregnancy & Lactation

Pregnancy: Adequate and well-controlled studies with aflibercept have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations.

Lactation: There is no information regarding the presence of aflibercept products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion.

Pediatric Use

A pediatric assessment for OPUVIZ demonstrates that OPUVIZ is safe and effective for pediatric patients in an indication for which EYLEA (aflibercept) is approved. However, OPUVIZ is not approved for such indication due to marketing exclusivity for EYLEA (aflibercept).