| 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), Diabetic
Macular Edema (DME), and Macular Edema following Retinal Vein Occlusion (RVO). |
| 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. |
| 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. |
| • |
Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients
should be instructed to report any change in vision without delay. |
|
| Adverse Reactions
|
| The most common adverse reactions (≥5%) reported in
patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%). |
| 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. |
| For Colorado Prescribers: In accordance with Colorado Law, please access
Wholesale Acquisition Cost (WAC) pricing information here. |