Vabysmo

— THERAPEUTIC CATEGORIES —
  • Miscellaneous ocular agents
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vabysmo Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Faricimab-svoa 120mg/mL; soln for intravitreal inj; preservative-free.

    Pharmacological Class

    Vascular endothelial growth factor (VEGF) inhibitor/angiopoietin-2 (Ang-2) inhibitor.

    How Supplied

    Single-dose vial—1 (w. needle)

    How Supplied

    Vabysmo is supplied as a clear to opalescent, colorless to brownish-yellow 120mg/mL solution in a single-dose glass vial.

    Each glass vial contains an overfill amount to allow for administration of a single 0.05mL dose of solution containing 6mg of faricimab-svoa.

    Each carton contains 1 glass vial and 1 sterile 5-micron blunt transfer filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm). 

    Storage

    Store in the refrigerator between 2°C to 8°C (36°F to 46°F).

    Do not freeze.

    Do not shake.

    Keep vial in original carton to protect from light.

    Prior to use, the unopened glass vial 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. 

    Manufacturer

    Genentech, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Faricimab is a humanized bispecific antibody that acts through inhibition of two pathways by binding to VEGF-A and 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 nAMD, DME, and RVO. The contribution of Ang-2 inhibition to the treatment effect and clinical response for nAMD, DME, and RVO has yet to be established.

    Vabysmo Indications

    Indications

    Neovascular (wet) age-related macular degeneration (nAMD). Diabetic macular edema (DME). Macular edema following retinal vein occlusion (RVO).

    Vabysmo Dosage and Administration

    Adult

    See full labeling. Give by intravitreal inj. nAMD: 6mg (0.05mL) once every 4 weeks (approx. every 28 ± 7 days, monthly) for the 1st 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to determine whether to give a 6mg (0.05mL) dose on one of the following 3 regimens: (1) Weeks 28 and 44; (2) Weeks 24, 36 and 48; or (3) Weeks 20, 28, 36 and 44. DME (Regimen 1): 6mg (0.05mL) once every 4 weeks for at least 4 doses, then may be adjusted by up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations; or (Regimen 2): 6mg (0.05mL) once every 4 weeks for the 1st 6 doses, followed by 6mg (0.05mL) every 8 weeks. RVO: 6mg (0.05mL) once every 4 weeks (approx. every 28 ± 7 days, monthly) for 6 months.

    Children

    Not established.

    Administration

    Using aseptic technique the intravitreal inj should be performed with a 30-gauge x ½-inch inj needle. Each vial/syringe should only be used to treat a single eye. If the contralateral eye requires treatment, a new vial/syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and inj needles should be changed before administered to the other eye. Discard any unused product.

    Vabysmo Contraindications

    Contraindications

    Ocular or periocular infection. Active intraocular inflammation.

    Vabysmo Boxed Warnings

    Not Applicable

    Vabysmo Warnings/Precautions

    Warnings/Precautions

    Must be administered by a qualified physician. Monitor for endophthalmitis, retinal detachments, elevation in IOP, and perfusion of optic nerve head following inj. Potential risk for arterial thromboembolic events (eg, nonfatal stroke or MI, vascular death). Discontinue if retinal vasculitis and/or retinal vascular occlusion with intraocular inflammation develops. Reevaluate periodically. Advise females of reproductive potential to use effective contraception prior to initial dose, during and for at least 3 months after the last dose. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    No data available on administration of Vabysmo to pregnant patients. 

    Vabysmo should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus.

    Nursing Mother Considerations

    No information available regarding the presence of faricimab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

    Pediatric Considerations

    Safety and efficacy in pediatric patients have not been established.

    Geriatric Considerations

    No dosage adjustment is required in patients 65 years of age and older.

    Other Considerations for Specific Populations

    Females of reproductive age: Use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of Vabysmo.

    Treatment with Vabysmo may pose a risk to reproductive capacity.

    Vabysmo Pharmacokinetics

    Absorption

    Maximum plasma concentrations (Cmax): ~2 days post-dose.

    Metabolism

    Expected to be catabolized in lysosomes to small peptides, amino acids.

    Elimination

    Renal. Half-life: 7.5 days.

    Vabysmo Interactions

    Not Applicable

    Vabysmo Adverse Reactions

    Adverse Reactions

    Conjunctival hemorrhage, vitreous floaters, increased IOP, eye pain, intraocular inflammation, eye irritation, ocular discomfort, retinal pigment epithelial tear (nAMD only).

    Vabysmo Clinical Trials

    Clinical Trials

    Neovascular (Wet) Age-Related Macular Degeneration and Diabetic Macular Edema

    The approval was based on data from two phase 3 trials in patients with wet age-related macular degeneration (TENAYA [ClinicalTrials.gov Identifier: NCT03823287] and LUCERNE [ClinicalTrials.gov Identifier: NCT03823300]) and two phase 3 trials involving patients with diabetic macular edema (YOSEMITE [ClinicalTrials.gov Identifier: NCT03622580] and RHINE [ClinicalTrials.gov Identifier: NCT03622593]).

    In the TENAYA and LUCERNE trials (N=1329), faricimab met the primary endpoint demonstrating noninferior visual acuity gains of +5.8 and +6.6 eye chart letters, respectively, compared with aflibercept (+5.1 and +6.6 letters, respectively).  

    In the YOSEMITE study (n=940), the average vision gains were +11.6 and +10.7 letters in the faricimab personalized treatment interval (PTI; up to 4 months) arm and the fixed 2-month interval arm, respectively, compared with +10.9 letters in the aflibercept arm. The RHINE study (N=951), which had an identical design, showed average vision gains of  +10.8 and +11.8 letters in the faricimab PTI and 2-month arms, respectively, and +10.3 letters in the aflibercept arm.

    Retinal Vein Occlusion

    The approval was based on data from the randomized, double-masked phase 3 BALATON (ClinicalTrials.gov Identifier: NCT04740905) and COMINO (ClinicalTrials.gov Identifier: NCT04740931) studies, which included 553 patients with macular edema due to branch RVO and 729 patients with macular edema secondary to central retinal or hemiretinal vein occlusion, respectively. Patients were randomly assigned 1:1 to receive faricimab 6mg every 4 weeks or aflibercept 2mg every 4 weeks for a total of 6 injections.

    The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. In both studies, faricimab was found to be noninferior to aflibercept, with average vision gains being comparable between the treatment groups (BALATON: +16.9 letters with faricimab vs +17.5 letters with aflibercept; COMINO: +16.9 letters with faricimab vs +17.3 letters with aflibercept). 

    Vabysmo Note

    Not Applicable

    Vabysmo Patient Counseling

    Patient Counseling

    Risk of developing endophthalmitis, retinal detachment, intraocular inflammation and retinal vasculitis with or without retinal vascular occlusion following Vabysmo administration.

    Seek immediate care if eye becomes red, sensitive to light, painful, or develops a change in vision.

    Temporary visual disturbances following intravitreal injection; do not drive or use machinery until visual function has recovered.

    Cost Savings Program

    Genentech Ophthalmology Co-pay Program

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