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Important Safety Information & Indications

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 infection, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Warnings and Precautions
Endophthalmitis and Retinal Detachments

Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure

Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). 

The incidence of reported ATEs in the nAMD studies during the first year was 1% (7 out of 664) in patients treated with VABYSMO compared with 1% (6 out of 662) in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies from baseline to week 100 was 5% (64 out of 1,262) in patients treated with VABYSMO compared with 5% (32 out of 625) in patients treated with aflibercept.

Adverse Reactions

The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

Pregnancy, Lactation, Females and Males of Reproductive Potential

Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VABYSMO and any potential adverse effects on the breastfed child from VABYSMO. Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of VABYSMO. 

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 additional Important Safety Information in the full VABYSMO Prescribing Information.

    • VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2023.

      VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2023.

    • Beovu® (brolucizumab-dbll) [package insert]. East Hanover, NJ: Novartis; 2022.

      Beovu® (brolucizumab-dbll) [package insert]. East Hanover, NJ: Novartis; 2022.

    • Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2023.

      Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2023.

    • LUCENTIS® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

      LUCENTIS® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

    • SUSVIMO™ (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2022.

      SUSVIMO™ (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2022.

    • Data on file. South San Francisco, CA: Genentech, Inc.

      Data on file. South San Francisco, CA: Genentech, Inc.

    • Regula JT, et al. EMBO Mol Med. 2016;8:1265-1288.

      Regula JT, et al. EMBO Mol Med. 2016;8:1265-1288.

    • Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635-661.

      Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635-661.

    • Fiedler U, et al. Trends Immunol. 2006;27(12):552-558.

      Fiedler U, et al. Trends Immunol. 2006;27(12):552-558.

    • Hawighorst T, et al. American Journ of Pathol. 2002;160(4):1381-1392.

      Hawighorst T, et al. American Journ of Pathol. 2002;160(4):1381-1392.

    • Avery RL, et al. Presented at American Association of Ophthalmology (AAO) 2022. Sept 30-Oct 03 2022.

      Avery RL, et al. Presented at American Association of Ophthalmology (AAO) 2022. Sept 30-Oct 03 2022.

    • Heier J, et al. Lancet. 2022;399(10326):729-740.

      Heier J, et al. Lancet. 2022;399(10326):729-740.

    • Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2022. Feb 11-12 2022.

      Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2022. Feb 11-12 2022.

    • Wykoff C, et al. Lancet. 2022;399(10326):741-755.

      Wykoff C, et al. Lancet. 2022;399(10326):741-755.

    • Baumal CR, et al. Presented at American Academy of Ophthalmology (AAO) 2022. Sep 30-Oct 03 2022.

      Baumal CR, et al. Presented at American Academy of Ophthalmology (AAO) 2022. Sep 30-Oct 03 2022.

    • Heier JS, et al. Presented at American Academy of Ophthalmology Retina Subspecialty Day (AAO-SSD) 2021. Nov 12-13 2021.

      Heier JS, et al. Presented at American Academy of Ophthalmology Retina Subspecialty Day (AAO-SSD) 2021. Nov 12-13 2021.

    • Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022. May 1-4 2022.

      Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022. May 1-4 2022.

    • Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964-972.

      Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964-972.

    • Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.

      Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.