NOW AVAILABLE WHERE 2 WORLDS MEET The First and Only Dual-Pathway Inhibitor in Retinal Disease 1-5 VABYSMO Is the First IVT Injection Approved for Q4W-Q16W Dosing Intervals in nAMD and DME 1-4 * Visit VABYSMO-HCP.com INDICATIONS VABYSMO (faricimab-svoa) is a vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME). IMPORTANT SAFETY INFORMATION Contraindications VABYSMO is contraindicated in patients with ocular or periocular inflammation, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Warnings and Precautions • Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management. • Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. • There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition. Adverse Reactions The most common adverse reaction (≥5%) reported in patients receiving VABYSMO was conjunctival hemorrhage (7%). You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Please see Brief Summary of VABYSMO full Prescribing Information on the following page. * Dosing Information: In nAMD, the recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/mL solution) IVT Q4W for the first 4 doses, followed by OCT and visual acuity evaluations 8 and 12 weeks later to inform whether to extend to: 1) Q16W (weeks 28 and 44); 2) Q12W (weeks 24, 36, and 48); or 3) Q8W (weeks 20, 28, 36, and 44). In DME, the recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/ mL solution) IVT Q4W for ≥4 doses until CST is ≤325 µm (by OCT), followed by treat-and-extend dosing with 4-week interval extensions or 4-to 8-week interval reductions based on CST and visual acuity evaluations through week 52. Alternatively, VABYSMO can be administered IVT Q4W for the first 6 doses, followed by Q8W dosing over the next 28 weeks. Although VABYSMO may be dosed as frequently as Q4W, additional efficacy was not demonstrated in most patients when VABYSMO was dosed Q4W vs Q8W. Some patients may need Q4W dosing after the first 4 doses. Patients should be assessed regularly and the dosing regimen reevaluated after the first year. CST=central subfield thickness; IVT=intravitreal; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks. References: 1. VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022. 2. Beovu ® (brolucizumab) [package insert]. East Hanover, NJ: Novartis; 2020. 3. Eylea ® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2021. 4. LUCENTIS ® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018. 5. SUSVIMO TM (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2021. VABYSMO is a registered trademark of Genentech, Inc., and the VABYSMO logo is a trademark of Genentech, Inc. ©2022 Genentech, Inc. 1 DNA Way, South San Francisco, CA 94080-4990. All rights reserved. M-US-00013122(v1.0) 02/22
Ophthalmology Management July 2022: Cover2
