Faricimab-svoa (Intravitreal) (Monograph)

Brand name: Vabysmo
Drug class: Vascular Endothelial Growth Factor Antagonists

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Humanized bispecific IgG₁ antibody that binds to and inhibits vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2).

Uses for Faricimab-svoa (Intravitreal)

Neovascular Age-Related Macular Degeneration

Treatment of patients with neovascular (“wet”) age-related macular degeneration.

Specific place in therapy not yet established; however, intravitreal anti-VEGF agents are commonly used for treatment of neovascular age-related macular degeneration.

Diabetic Macular Edema

Treatment of patients with diabetic macular edema.

Specific place in therapy not yet established; however, intravitreal anti-VEGF agents are generally used first-line for treatment of center-involved diabetic macular edema.

Macular Edema Following Retinal Vein Occlusion

Treatment of patients with macular edema following retinal vein occlusion.

Specific place in therapy not yet established; however, intravitreal anti-VEGF agents are generally used first-line for treatment of macular edema secondary to retinal vein occlusion.

Faricimab-svoa (Intravitreal) Dosage and Administration

General

Patient Monitoring

• Monitor for elevations in intraocular pressure (IOP) using tonometry or a check for perfusion of the optic nerve head following intravitreal injection of faricimab-svoa.

• Monitor for changes in vision and any symptoms suggestive of endophthalmitis or retinal detachment (e.g., vision loss, eye pain or redness, photophobia, blurred vision).

• If administered for neovascular age-related macular degeneration, perform optical coherence tomography and visual acuity evaluations 8 and 12 weeks after the fourth dose to determine the number and timing of subsequent doses. Assess response regularly.

• If administered for diabetic macular edema, perform optical coherence tomography and visual acuity evaluations regularly to assess whether dosing interval adjustment is warranted. Assess response regularly.

Premedication and Prophylaxis

• Administer adequate anesthesia and a broad-spectrum microbicide prior to intravitreal injection.

Administration

Intravitreal Administration

Administer by intravitreal injection.

Available as a 120 mg/mL clear to opalescent, colorless to brownish-yellow solution for intravitreal injection in single-dose vials.

Must be administered by qualified physician.

Prepare intravitreal injection using aseptic technique. Withdraw solution from vial using the sterile 5-micron blunt transfer filter needle provided by the manufacturer. Attach filter needle to a 1 mL Luer lock syringe with a 0.05 mL dose mark, push filter needle all the way into the vial, then tilt vial so that the filter needle touches the bottom edge of the vial. Hold vial slightly inclined and slowly withdraw all the liquid, avoiding introduction of air, by keeping the bevel of the needle submerged in the liquid. Filter needle is for single use only.

Once solution is transferred to the syringe, disconnect and discard filter needle; do not use filter needle for administration.

Use a sterile 30-gauge, 0.5-inch needle to administer the intravitreal injection.

Administer injection immediately after preparation of the dose under aseptic conditions.

Use each vial for treatment of a single eye only.

If contralateral eye also requires treatment, use a new syringe and change the sterile field and other necessary supplies before administration.

Dosage

Adults

Neovascular Age-Related Macular Degeneration

Intravitreal

Initial: 6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection every 4 weeks (approximately every 28 ± 7 days) for the first 4 doses.

Perform optical coherence tomography and visual acuity evaluations 8 and 12 weeks after the fourth dose.

Based on results, administer additional 6-mg doses of intravitreal faricimab-svoa according to 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.

Assess patients regularly; some may need every 4 week dosing after the first 4 doses.

Diabetic Macular Edema

Intravitreal

Follow one of two regimens.

Regimen 1: 6 mg (0.05 mL of 120 mg/mL solution) 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 on optical coherence tomography) is achieved, then dosing interval 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.

Regimen 2: 6 mg by intravitreal injection every 4 weeks for the first 6 doses, then every 8 weeks (2 months). Some patients may need every 4 week dosing after the first 4 doses.

Assess patients regularly.

Macular Edema Following Retinal Vein Occlusion

Intravitreal

6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for 6 months.

Special Populations

Hepatic Impairment

No dosage recommendations at this time; not studied.

Renal Impairment

Cl_cr≥15 mL/minute/1.73 m²: No dosage adjustment necessary.

Cl_cr <15 mL/minute/1.73 m²: No dosage recommendations at this time; not studied.

Geriatric Patients

Dosage adjustment not necessary in geriatric patients.

Related/similar drugs

Eylea, Syfovre, triamcinolone ophthalmic, dexamethasone ophthalmic, Izervay, fluocinolone ophthalmic, Ozurdex

Cautions for Faricimab-svoa (Intravitreal)

Contraindications

• Ocular or periocular infection.

• Active intraocular inflammation.

• Hypersensitivity to faricimab or any excipients in the formulation.

Warnings/Precautions

Endophthalmitis and Retinal Detachments

Intravitreal injections associated with endophthalmitis and retinal detachment.

Always use proper aseptic injection techniques during administration.

Instruct patients to immediately report signs or symptoms suggestive of endophthalmitis or retinal detachment (e.g., vision loss, eye pain, eye redness, photophobia, blurry vision), and promptly initiate appropriate management.

Increase in Intraocular Pressure

Transient increases in intraocular pressure (IOP) observed within 60 minutes of intravitreal injection.

Monitor IOP and perfusion of the optic nerve head; manage appropriately.

Thromboembolic events

Arterial thromboembolic events, defined as nonfatal stroke, nonfatal MI, and vascular death, observed at low rates in clinical studies.

Risk of arterial thromboembolic events exists with intravitreal injection of VEGF inhibitors.

Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion reported, typically in the presence of intraocular inflammation.

Instruct patients to report any changes in vision without delay. Discontinue faricimab if these events occur.

Immunogenicity

Potential for immunogenicity; anti-faricimab antibodies reported in patients treated with the drug.

Specific Populations

Pregnancy

Adequate data not available in pregnant women.

Based on mechanism of action, risk to female reproductive capacity and embryo-fetal development exists.

Do not use during pregnancy unless benefits outweigh potential risks.

Lactation

Not known if present in human milk. Effects on milk production and on the breast-fed child unknown. Consider developmental and health benefits of breastfeeding in addition to mother's clinical need for the drug and potential for adverse effects on the breast-fed child.

Females and Males of Reproductive Potential

Advise females of reproductive potential to use effective contraception prior to treatment initiation, during treatment, and for a minimum of 3 months following the last dose.

Human fertility studies not conducted; may pose risk to reproductive capacity based on mechanism of action.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

No differences in safety or efficacy observed with increased age. No dosage adjustment necessary for patients ≥65 years of age.

Hepatic Impairment

Pharmacokinetics not studied in any degree of hepatic impairment.

Renal Impairment

Pharmacokinetics not affected by mild to severe renal impairment (Cl_cr 15—89 mL/minute/1.73 m²). Pharmacokinetics in severe renal impairment (Cl_cr <15 mL/minute/1.73 m²) not studied.

Common Adverse Effects

Adverse effects reported in ≥5% of patients included cataract and conjunctival hemorrhage.

Drug Interactions

Formal drug interaction studies not conducted.

Faricimab-svoa (Intravitreal) Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations attained 2 days following intravitreal administration.

No accumulation of faricimab-svoa expected in the vitreous and none observed in plasma following repeat intravitreal injections.

Special Populations

Systemic exposure not affected by increased age, gender, race, or mild to severe renal impairment (Cl_cr15—89 mL/minute/1.73 m² based on Cockcroft Gault equation).

Distribution

Extent

Not known if excreted into breast milk.

Elimination

Metabolism

Metabolism not fully characterized; expected to undergo catabolism to small peptides and amino acids in lysosomes.

Elimination Route

Elimination not fully characterized; expected to undergo renal excretion following catabolism to small peptides and amino acids.

Half-life

7.5 days.

Stability

Storage

Intravitreal

Injection for intravitreal use

Store in the refrigerator at 2—8°C; protect from light.

Unopened vial may be kept at room temperature (20—25°C) for up to 24 hours prior to use.

Actions

• Humanized bispecific IgG₁ antibody.

• Binds to vascular endothelial growth factor A (VEGF-A) and angiopoetin-2 (Ang-2).

• Inhibition of VEGF-A suppresses endothelial cell proliferation, neovascularization, and vascular permeability.

• Inhibition of Ang-2 thought to promote vascular stability and desensitize blood vessels to VEGF-A effects. Extent to which Ang-2 inhibition contributes to treatment efficacy and clinical response not yet established; levels of Ang-2 increased in some patients with neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.

Advice to Patients

• Inform patients that in the days following faricimab-svoa administration, they are at risk of developing endophthalmitis, retinal detachment, intraocular inflammation, and retinal vasculitis (with or without retinal vascular occlusion). Advise patients to seek immediate care from an opthalmologist if vision changes develop or the eye becomes red, painful, or sensitive to light.

• Inform patients that temporary visual disturbances may occur after intravitreal injection and the associated eye examinations. Advise patients to avoid driving or using machinery until visual function has adequately recovered.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Advise women of reproductive potential to use effective contraception prior to treatment initiation, during treatment, and for a minimum of 3 months following the last dose of faricimab-svoa.

• Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Faricimab-svoa is obtained through designated specialty pharmacies. Contact manufacturer or consult the manufacturer website for specific availability information.

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