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Important Safety Information
Important Safety Information
What is VABYSMO?
VABYSMO (faricimab-svoa) is a prescription medicine given by injection into the eye used to treat adults with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).
Do not receive VABYSMO if you:
- Have an infection in or around your eye.
- Have active swelling around your eye that may include pain and redness.
- Are allergic to VABYSMO or any of the ingredients in VABYSMO.
What is the most important information I should know about VABYSMO?
- Injections like the one for VABYSMO can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Call your healthcare provider right away if you have increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
- VABYSMO may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs within 60 minutes after receiving the eye injection.
- Although not common, VABYSMO patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with VABYSMO reported such an event. In clinical studies for DME from baseline to week 100, 64 out of 1,262 patients treated with VABYSMO reported such an event. In clinical studies for RVO during 6 months, 7 out of 641 patients treated with VABYSMO reported such an event.
- Severe inflammation of vessels in the retina has happened for patients treated with VABYSMO. Call your healthcare provider immediately if you experience a change in vision.
Before receiving VABYSMO, tell your healthcare provider about all of your medical conditions, including if you:
- Are pregnant or plan to become pregnant. Based on how VABYSMO interacts with your body, there may be a potential risk to your unborn baby. You should use birth control before your first injection, during your treatment with VABYSMO, and for 3 months after your last dose of VABYSMO.
- Are breastfeeding or plan to breastfeed. It is not known if VABYSMO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive VABYSMO.
- Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about all the medicines you take.
What should I avoid while receiving VABYSMO?
- Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.
What are the most common side effects with VABYSMO?
- The most common side effects with VABYSMO were cataract and blood on the white of the eye (conjunctival hemorrhage).
- These are not all the possible side effects of VABYSMO.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
Please see the VABYSMO full Prescribing Information for additional Important Safety Information.