Vabysmo
Pronunciation: vah-BYE-smo
Generic name: faricimab-svoa
Dosage form: intravitreal injection (120 mg/mL single-dose vial), (120 mg/mL solution single-dose prefilled syringe)
Drug class: Anti-angiogenic ophthalmic agents
What is Vabysmo Injection?
Vabysmo injection is a treatment for macular degeneration and macular edema to help improve and maintain vision in certain patients. Vabysmo eye injection is used specifically for wet (neovascular) age-related macular degeneration (nAMD), diabetic macular edema (DME), or macular edema following retinal vein occlusion (RVO) in adults.
Wet (neovascular) AMD, DME, and macular edema following RVO are among the leading causes of vision loss. Normally, in healthy eyes, blood vessels supply blood to nourish the eye. In wet AMD, DME, and macular edema, two proteins, called VEGF and Ang-2, let abnormal blood vessels grow, swell, and cause fluid to leak, which may lead to eye damage and possible vision loss.
Vabysmo injection works by blocking both types of proteins (VEGF and Ang-2) to help reduce abnormal blood vessel swelling, help reduce leaking fluid, and help reduce blood vessel growth to help maintain and improve vision.
Vabysmo (faricimab-svoa) mechanism of action is as a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor that is given by injection into the eye. Vabysmo is a bispecific antibody.
Vabysmo is given as an injection into the eye (intravitreal injection) every four weeks for the first four doses, then the dosing interval may change depending on the results of eye evaluations and which condition is being treated.
Vabysmo is available as a prefilled syringe (PFS) and a single-dose vial.
Who can use Vabysmo?
Vabysmo injection is an FDA-approved medication to treat:
- Wet (neovascular) age-related macular degeneration (nAMD)
- Diabetic macular edema (DME), or
- Macular edema following retinal vein occlusion (RVO).
Vabysmo side effects
Common Vabysmo side effects
Common Vabysmo side effects are cataracts (15%) and bleeding in the white part of the eye (8%).
Serious Vabysmo side effects
Vabysmo may cause serious side effects. Call your doctor at once if you have:
- signs of eye infection - swelling, severe discomfort, crusting, or drainage;
- severe eye redness or pain;
- eyes being more sensitive to light; or
- changes in your vision.
Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warnings
Do not receive Vabysmo eye injection if you:
- have an infection in or around your eye
- your eye is red, inflamed, or painful
- are allergic to the active ingredient aricimab-svoa or any of the inactive ingredients. See the bottom of this document for a full list of ingredients.
Eye infections (endophthalmitis) or separation of the layers of the retina (retinal detachment) can occur following eye injections such as Vabysmo. Call your healthcare provider right away if you have:
- increasing eye pain
- vision loss
- sensitivity to light
- redness in the white of the eye.
Temporary increases in the pressure in the eye (also called intraocular pressure) within 60 minutes of an injection have been reported with Vabysmo.
There is a risk of serious, sometimes fatal, blood clots, such as heart attacks or strokes (thromboembolic events) associated with the use of VEGF inhibitors, such as Vabysmo.
Before receiving Vabysmo
You should not receive Vabysmo eye injection if you are allergic to it, or if you have:
- swelling, redness, pain inside or around your eyes; or
- any type of infection in or around your eyes.
Tell your doctor if you have ever had:
- a heart attack or stroke; or
- glaucoma or any other condition that increases pressure inside your eyes.
Pregnancy
Tell your healthcare provider if you are pregnant or planning a pregnancy, as there is a potential risk to the unborn baby from Vabysmo. You should use effective birth control while using this medicine and for at least 3 months after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
Breastfeeding
Ask a doctor if it is safe to breastfeed while using this medicine. It is not known if Vabysmo passes into breast milk. Talk to your doctor about the best way to feed your baby if you receive this medicine.
How should I receive Vabysmo?
Vabysmo is administered by a healthcare professional and is given as an injection into your eye. Your healthcare provider should anesthetize your eye first, so the injection is usually painless.
- A separate syringe will be used for each eye.
- Immediately after Vabysmo is administered, your healthcare provider will check for an increase in the fluid pressure in your eye (intraocular pressure).
- Vabysmo is usually given initially every 4 weeks for the first 4-6 doses and then as advised by your healthcare professional.
What is Vabysmo cost?
The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. For Vabysmo cost please refer to our price guide page for more information.
You may also be eligible for a Vabysmo savings card or Vabysmo coupon. Ask your doctor or pharmacist if you qualify.
Vabysmo dosing information
Neovascular (wet) age-related macular degeneration dosage
- The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) every 4 weeks, approximately for the first 4 doses.
- Your healthcare provider will then do optical coherence tomography and visual acuity evaluations after 8 and 12 weeks to guide further dosing, which dosing regime will be used thereafter.
- Regimen 1: Weeks 28 and 44; OR
- Regimen 2: Weeks 24, 36, and 48; OR
- Regimen 3: Weeks 20, 28, 36, and 44
Diabetic Macular Edema dosage
There are two main dosage regimens for Vabysmo for DME.
Regime one:
- 6 mg administered by intravitreal injection every 4 weeks for at least 4 doses. Further dosing is guided by optical coherence tomography.
Regime two:
- 6 mg administered by intravitreal injection every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months) over the next 28 weeks. Further dosing is guided by optical coherence tomography.
Macular Edema Following Retinal Vein Occlusion (RVO) dosage
- The recommended dose is 6 mg (0.05 mL of 120 mg/mL) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for 6 months.
Click the link below for detailed dosing instructions.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your faricimab ophthalmic injection.
What happens if I overdose?
In a medical setting, an overdose would be treated quickly.
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 other drugs will affect Vabysmo?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Click the link below to check for interactions with this medicine.
Storage
Store in the refrigerator between 2°C to 8°C (36°F to 46°F).
Do not freeze, do not shake, and keep the vial in the original carton to protect it from light.
Before use, the unopened glass vial of Vabysmo may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours. Once drawn up, the injection must be given immediately.
Ingredients
Active ingredient: faricimab 120mg/mL
Inactive ingredients: Each single-dose vial is designed to deliver 0.05 mL (50 microliters) of solution containing 6 mg faricimab-svoa, L-histidine (155 mcg), L-methionine (52.2 mcg), polysorbate 20 (20 mcg), sodium chloride (73.1 mcg), D-sucrose (2.74 mg) and Water for Injection, adjusted to pH 5.5 with acetic acid.
Does not contain an anti-microbial preservative.
Manufacturer
Genetech, Inc., a member of the Roche Group.
Popular FAQ
How fast does Vabysmo work?
Vabysmo may help you gain back some vision after one treatment. On average, people with wet age-related macular edema (wet AMD) gained 5 letters on an eye chart at 1 month with Vabysmo, similar to aflibercept (Eylea). In diabetic macular edema (DME) studies, people gained an average of 6 letters at 1 month, also similar to aflibercept.
What is the difference between Vabysmo and Eylea?
Vabysmo (faricimab) targets vascular endothelial growth factor (VEGF) and angiopoietin-1, whereas Eylea (afibercept) targets VEGF and placental growth factor (P1GF). Both agents are used to treat conditions such as macular degeneration (AMD) and diabetic macular edema and are given by intravitreal injection (into the gel part of the eye). Continue reading
What is the mechanism of action for Vabysmo?
Vabysmo (faricimab) works by blocking two pathways that cause abnormal blood vessel growth in the eye. It attaches to vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), which stops them from working normally. Continue reading
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.