Faricimab

What is Faricimab?

• Faricimab (Vabysmo) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor used to treat neovascular (wet) aged-related macular degeneration and diabetic macular edema.

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What are the uses of this medicine?

Faricimab (Vabysmo) used for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
• Diabetic Macular Edema (DME)

How does this medicine work?

• Faricimab is a humanized bispecific antibody that acts through inhibition of two pathways by binding to vascular endothelial growth factor (VEGF-A) and angiopoietin-2 (Ang-2).
• By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability.
• By inhibiting Ang-2, faricimab is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A.
• Ang-2 levels are increased in some patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME).
• The contribution of Ang-2 inhibition to the treatment effect and clinical response for nAMD and DME has yet to be established.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• ocular or periocular infections
• active intraocular inflammation
• with known hypersensitivity to faricimab or any of the excipients in Vabysmo

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.

Is this medicine FDA approved?

• Faricimab was developed by Roche.
• Faricimab was approved for medical use in the United States in January 2022.

How should this medicine be used?

Recommended dosage: Neovascular (Wet) Age-Related Macular Degeneration (nAMD):

• The recommended dose for Vabysmo is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens:
• 1) Weeks 28 and 44
• 2) Weeks 24, 36 and 48 or
• 3) Weeks 20, 28, 36 and 44.
• Although additional efficacy was not demonstrated in most patients when Vabysmo was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses.
• Patients should be assessed regularly.

Diabetic Macular Edema (DME): Vabysmo is recommended to be dosed by following one of these two dose regimens:

• 1) 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses.
• If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations through week 52

• 2) 6 mg dose of Vabysmo can be administered 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.
• Although additional efficacy was not demonstrated in most patients when Vabysmo was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses.
• Patients should be assessed regularly.

Administration:

• Vabysmo should be inspected visually for particulate matter and discoloration prior to administration.
• Vabysmo is a clear to opalescent and colorless to brownish-yellow liquid solution.
• Use aseptic technique to carry out the preparation of the intravitreal injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 120 mg/mL solution in a single-dose vial

This medicine is available in fallowing brand namesː Vabysmo

What side effects can this medication cause?

The most common side effects of this medicine include:

• Conjunctival hemorrhage
• Vitreous floaters
• Retinal pigment epithelial tear
• Intraocular pressure increased
• Eye pain
• Intraocular inflammation
• Eye irritation
• Ocular discomfort
• Vitreous hemorrhage

Vabysmo may cause serious side effects, including:

• Hypersensitivity
• Endophthalmitis and retinal detachments
• Increase in intraocular pressure
• Thromboembolic events

What special precautions should I follow?

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.
• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.
• There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition.
• Patients may experience temporary visual disturbances after an intravitreal injection with Vabysmo and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Vabysmo administration in pregnant women.

Can this medicine be used in children?

• The safety and efficacy of Vabysmo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• FARICIMAB

Inactive ingredients:

• histidine
• methionine
• sodium chloride
• sucrose
• polysorbate 20
• water
• acetic acid

Who manufactures and distributes this medicine?

Manufactured by:

• Genentech, Inc.
• A Member of the Roche Group
• 1 DNA Way
• South San Francisco, CA

What should I know about storage and disposal of this medication?

• Store Vabysmo in the refrigerator between 2°C to 8°C (36°F to 46°F).
• Do not freeze.
• Do not shake.
• Keep the vial in the original carton to protect from light.
• Prior to 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.
• Ensure that the injection is given immediately after preparation of the dose.

• Dailymed label info on Faricimab
• FDA Faricimab