Vabysmo

Vabysmo (faricimab-svoa) is a prescription treatment for wet age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO) in adults used to help improve or maintain vision.

Vabysmo is used to help improve and maintain vision. If these eye conditions are not treated, it may lead to reduced or distorted vision or vision loss.

Vabysmo is administered as an intravitreal (into the eye) injection usually every four weeks for the first four doses, then the dosing schedule may change based on how the eye responds to treatment and the specific condition being treated. It is available as a prefilled syringe (PFS) and a single-dose vial.

Vabysmo mechanism of action is as a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.

Vabysmo works by targeting and blocking two specific proteins in the eye called VEGF and Ang-2, which contribute to abnormal blood vessel growth, swelling, and fluid leakage within the eye.

When Vabysmo blocks VEGF and Ang-2, it helps to reduce swelling and leakage within the eye, which may to slow damage to the retina and preserve vision.

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.

The Vabysmo cost 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.

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.

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.

Common Vabysmo side effects

• blurred vision, eye pain or redness, seeing halos around lights;
• bleeding in the white part of the eye.

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.

Neovascular (wet) age-related macular degeneration dose

• 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, and 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 dose

There are two main dose schedules 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) dose

• 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).

Vabysmo J Code is J2777 (0.1 mg, injection)

J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. Your physician will need the J code when filling out forms for your treatment.

Call your doctor for instructions if you miss an appointment for your faricimab ophthalmic injection.

In a medical setting, an overdose would be treated quickly.

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.

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.

HCPs and patients often use the Vabysmo Prescribing Information for more detailed information about this medicine. The Prescribing Information contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Prescribing Information is sometimes called the Vabysmo Package Insert or FDA label.

When you have a retinal vein occlusion, veins in the back of the eye become blocked, causing fluid to leak into the eye. Depending on the size and location of the blockage, this can lead to blurred vision or vision loss. The two proteins VEGF and Ang-2 are involved in fluid leakage and swelling.When Vabysmo blocks VEGF and Ang-2, it may help improve vision in Macular edema following RVO.

In diabetic macular edema, too much blood sugar damages blood vessels in the back of the eye, in an area called the macula. This is part of the eye that controls sharp, straight-ahead vision. Fluid leaks out of the damaged blood vessels, causing the macula to swell and resulting in blurred vision and vision loss. The two proteins, VEGF and Ang-2, are involved in fluid leakage and swelling. When Vabysmo blocks VEGF and Ang-2, it may help improve vision in diabetic macular edema.

Age-related macular degeneration (AMD) is an eye disease due to aging, causing damage to the macula, which is important for sharp, straight-ahead vision. Wet AMD is caused by abnormal blood vessels growing in the macular part of the eye. These blood vessels leak fluid, causing swelling with blurring and vision loss. The two proteins, VEGF and Ang-2, are involved in fluid leakage and swelling. When Vabysmo blocks VEGF and Ang-2, it may help improve vision in wet age-related macular degeneration. Wet age-related macular degeneration is sometimes called neovascular age-related macular degeneration.

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.

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.

Manufactured by: Genentech, Inc.A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990