Aflibercept-mrbb · intravitreal injection
Injections & Implants
AHZANTIVE 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 AHZANTIVE is contraindicated in patients with ocular or periocular infections.
2 mg, 0.05 mL, 40 mg/mL
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.
2.1 Important Injection Instructions For ophthalmic intravitreal injection. AHZANTIVE must only be administered by a qualified physician. Pre-filled Syringe: A 30-gauge × ½-inch sterile injection needle is needed but not provided. Vial: A 5-micron sterile filter needle (18-gauge × 1½-inch), a 1-mL sterile Luer lock syringe and a 30‑gauge × ½-inch sterile injection needle are needed, but not provided.
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 AHZANTIVE.
- 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.
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.
A pediatric assessment for AHZANTIVE demonstrates that AHZANTIVE is safe and effective for pediatric patients in an indication for which EYLEA (aflibercept) is approved. However, AHZANTIVE is not approved for such indication due to marketing exclusivity for EYLEA (aflibercept).