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Prescribing Information Prescribing Information Important Safety Information
Important Safety Information Contact Genentech Contact Genentech For Patients &
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 * HOW VABYSMO WORKS
 * nAMD DATA
    * Dosing & Study Design
    * Clinical Data

 * DME DATA
    * Dosing & Study Design
    * Clinical Data

 * RVO DATA
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Prescribing Information Important Safety Information Contact Genentech For
Patients & Caregivers
 1. VIDEOS & RESOURCES
 2. OTHER RESOURCES


RESOURCES FOR YOUR PRACTICE AND YOUR PATIENTS


PHYSICIAN AND OFFICE STAFF RESOURCES TO DOWNLOAD

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VABYSMO Access & Reimbursement Guide
Sample Letter of Medical Necessity for VABYSMO
Access & Reimbursement Guide (Español)
VABYSMO Sample Billing and Coding Information for nAMD
VABYSMO Sample Billing and Coding Information for DME
VABYSMO Sample Billing and Coding Information for RVO
Understanding the Benefits Investigation Report Brochure
Genentech Patient Foundation Enrollment Form
Sample Appeal Letter for VABYSMO
Prescriber Service Form
Sample Avastin Step Back Appeal Letter for VABYSMO
Enrolling in My Patient Solutions User Guide
VABYSMO Ordering Guide
VABYSMO J-Code Announcement


PATIENT RESOURCES TO DOWNLOAD

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Patient Consent Form
Ophthalmology Financial Assistance Leave-Behind
Patient Consent Form (Español)
Ophthalmology Financial Assistance Leave-Behind (Español)


IMPORTANT SAFETY INFORMATION & INDICATIONS

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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.



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