AHZANTIVE (aflibercept-mrbb)

14.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) The safety and efficacy of aflibercept were assessed in two randomized, multi-center, double-masked, active-controlled studies in patients with wet AMD. A total of 2412 patients were treated and evaluable for efficacy (1817 with aflibercept) in the two studies (VIEW1 and VIEW2). In each study, up to week 52, patients were randomly assigned in a 1:1:1:1 ratio to 1 of 4 dosing regimens: 1) aflibercept administered 2 mg every 8 weeks following 3 initial monthly doses (aflibercept 2Q8); 2) aflibercept administered 2 mg every 4 weeks (af...

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3)] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1)] Increase in intraocular pressure [see Warnings and Precautions (5.2)] Thromboembolic events [see Warnings and Precautions (5.3)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adver...

4.1 Ocular or Periocular Infections AHZANTIVE is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation AHZANTIVE is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity AHZANTIVE is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in AHZANTIVE. Hypersensitivity reactions...

5.1 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 [see Adverse Reactions (6.1)] and, more rarely, retinal vasculitis with or without occlusion [see Adverse Reactions (6.2)]. Proper aseptic injection technique must always be used when administering AHZANTIVE. Patients and/or caregivers should be instructed to report any sign...