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Dosing & Administration in DME

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VABYSMO PFS

The VABYSMO Prefilled Syringe is now available to order

Commercial product will be available as early as the week of September 3, 2024

The VABYSMO PFS is co-packaged with the first FDA-cleared Injection Filter Needle for intravitreal injection¹

The VABYSMO Prefilled Syringe

Deliver the difference in 3 key steps

Allow VABYSMO to reach room temperature (68–77°F) and visually inspect before use^1*

How to snap the cap off

SNAP
the cap

Aseptically remove the PFS, hold it by the white collar, and then snap the cap off¹

How to secure the needle

SECURE
the needle

Secure the provided Injection Filter Needle by firmly attaching it to the syringe Luer Lock¹

How to set the dose

SET
the dose

Set the dose by gradually pushing the plunger rod until the lower edge of the rubber stopper dome is aligned with the 0.05 mL dose mark¹

*The PFS may be kept at room temperature in the original carton for up to 24 hours.¹

Please see additional details for preparation and administration in the full VABYSMO Prescribing Information.

Explore the difference within

Durability in DME

START FIRST WITH VABYSMO

~90% of patients are covered to start VABYSMO as their first branded treatment^†

Billing & Coding Updates

PFS NDC codes
50242-096-06
50242-0096-06

Same J-code
J2777

VABYSMO Access & Support

These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

^†Coverage determined for VABYSMO vial based on Medicare Fee for Service and tracking of the largest payers for other books of business. Bevacizumab (not indicated for intraocular use) and biosimilars are excluded from the branded treatment category. Specific coverage may vary for individuals and plans. Data as of January 2024.

VABYSMO VIAL

Get the most out of every VABYSMO vial

Tap, tilt, and draw: Explore the key steps for preparation

DOSING

Start with flexible 1–4 month dosing¹

Recommended dose for VABYSMO is 6 mg administered via one of two regimens:¹

Recommended dosing is 4 monthly loading doses followed by Q16W, Q12W, Q8W, or Q4W (no added benefit) dosing

^‡Although VABYSMO may need to be dosed as frequently as every 4 weeks after the first 4 doses, additional efficacy was not demonstrated in most patients compared to every 8 weeks.^{1

§}If resolution of fluid based on CST is achieved, the interval may be modified based on CST and visual acuity in ≤4-week increment extensions, or ≤8-week increment reductions.¹

What are experts saying about the value of flexible 1–4 month dosing?

CST=central subfield thickness; DME=diabetic macular edema; OCT=optical coherence tomography; PFS=prefilled syringe; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.

START FIRST WITH VABYSMO

Our dedicated Field Reimbursement Team will support you every step of the way

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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. 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.

The incidence of reported ATEs in the RVO studies during the first 6 months was 1.1% (7 out of 641) in patients treated with VABYSMO compared with 1.4% (9 out of 635) in patients treated with aflibercept.

Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of VABYSMO. Healthcare providers should discontinue treatment with VABYSMO in patients who develop these events. 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%).

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; 2024.
  
  VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2024.
- Data on file. South San Francisco, CA: Genentech, Inc.
  
  Data on file. South San Francisco, CA: Genentech, Inc.
- 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.
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  Avery RL, et al. Presented at American Association of Ophthalmology (AAO) 2022. Sept 30–Oct 03 2022.
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  Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2022. Feb 11–12 2022.
- Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2024. Feb 03 2024.
  
  Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2024. Feb 03 2024.
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  Wykoff C, et al. Lancet. 2022;399(10326):741–755.
- 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.
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  Goldberg R, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023. April 23–27 2023.
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  Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022. May 1–4 2022.