Macular degeneration, age-related, neovascular (wet):
Intravitreal: Initial: 6 mg once every 4 weeks (approximately every 28 days) for 4 doses (Heier 2022; manufacturer's labeling). Subsequent doses are individualized based on visual assessments, and are administered as one of the following regimens:
Every-8-week regimen: 6 mg on weeks 20, 28, 36, and 44 (Heier 2022; manufacturer's labeling).
Every-12-week regimen: 6 mg on weeks 24, 36, and 48 (Heier 2022; manufacturer's labeling).
Every-16-week regimen: 6 mg on weeks 28 and 44 (Heier 2022; manufacturer's labeling).
Note: Additional efficacy was not demonstrated with dosing every 4 weeks throughout therapy; however, some patients may require dosing every 4 weeks following the initial 4 doses.
Macular edema, diabetic: Doses may be administered based on one of the following regimens:
Fixed interval regimen: Intravitreal: 6 mg once every 4 weeks (approximately every 28 days) for 6 doses, followed by 6 mg once every 8 weeks over the next 28 weeks (total duration: 52 weeks) (Wykoff 2022; manufacturer's labeling).
Variable interval regimen: Intravitreal: 6 mg once every 4 weeks (approximately every 28 days) for at least 4 doses, followed by 6 mg every 4 to 16 weeks (based on visual assessments) through week 52 (Wykoff 2022; manufacturer's labeling).
Note: Additional efficacy was not demonstrated with dosing every 4 weeks throughout therapy; however, some patients may require dosing every 4 weeks following the initial 4 doses.
CrCl ≥15 mL/minute/1.73 m2: No dosage adjustment necessary.
CrCl <15 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal [preservative free]:
Vabysmo: Faricimab-svoa 6 mg/0.05 mL (120 mg/mL) (0.05 mL)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal:
Vabysmo: 6 mg/0.05 mL (0.05 mL)
Intravitreal: For ophthalmic intravitreal injection only. Administer under aseptic conditions. Allow vial to reach room temperature prior to administration. Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before faricimab is administered to the other eye. Adequate anesthesia and a topical broad-spectrum antimicrobial agent should be administered prior to the procedure. Refer to manufacturer's labeling for additional detailed information.
Macular degeneration, age-related, neovascular (wet): Treatment of neovascular (wet) age-related macular degeneration.
Macular edema, diabetic : Treatment of diabetic macular edema.
Conjunctival hemorrhage; increased intraocular pressure (IOP); intraocular inflammation (including iridocyclitis, iritis, uveitis, vitritis); retinal pigment epithelium tear; and vitreous opacity have been frequently reported with faricimab use. Corneal abrasion, decreased visual acuity (transient), endophthalmitis, ocular hyperemia, rhegmatogenous retinal detachment, retinal hole without detachment, and vitreous hemorrhage have also been reported rarely.
Mechanism:
IOP: Unknown; addition of fluid into the vitreous cavity may lead to transient increases in IOP. The mechanism for sustained increases in IOP is not well understood; proposed mechanisms include pharmacologic effect of vascular endothelial growth factor (VEGF) blockade, an anti-inflammatory mechanism/trabeculitis, impaired outflow due to protein aggregates/silicone droplet debris, and damage to outflow pathways (Ref).
Rhegmatogenous retinal detachment: Unknown; possibly related to induction of posterior vitreous detachment (Ref).
Onset: IOP: Rapid; within 60 minutes of administration.
Risk factors:
Endophthalmitis:
• Intravitreal injection posteriorly to the pars plana (Ref)
IOP:
• Greater number of intravitreal injections (VEGF inhibitor and/or steroid) (Ref)
• Personal or family history of glaucoma (Ref)
Arterial thromboembolism, including acute myocardial infarction and cerebrovascular accident, have been reported with faricimab use.
Mechanism: Dose-related; related to the pharmacologic action. Possibly due to systemic absorption of faricimab following intravitreal injection, leading to systemic vascular endothelial growth factor suppression (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Cardiovascular: Arterial thromboembolism (1% to 2%; including acute myocardial infarction and cerebrovascular accident) (table 1)
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
2% |
2% |
Diabetic macular edema |
1,262 |
625 |
|
1% |
0.9% |
Neovascular (wet) age-related macular degeneration |
664 |
662 |
Immunologic: Antibody development (8% to 10%)
Ophthalmic: Conjunctival hemorrhage (7%) (table 2), eye discomfort (1%), eye irritation (1%), eye pain (2% to 3%), increased intraocular pressure (3%) (table 3), intraocular inflammation (1% to 2%; including iridocyclitis, iritis, uveitis, vitritis) (table 4), retinal pigment epithelium tear (3%) (table 5), vitreous hemorrhage (≤1%) (table 6), vitreous opacity (3%) (table 7)
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
7% |
6% |
Diabetic macular edema |
1,262 |
625 |
|
7% |
8% |
Neovascular (wet) age-related macular degeneration |
664 |
622 |
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
3% |
2% |
Diabetic macular edema |
1,262 |
625 |
|
3% |
2% |
Neovascular (wet) age-related macular degeneration |
664 |
622 |
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
1% |
1% |
Diabetic macular edema |
1,262 |
625 |
|
2% |
1% |
Neovascular (wet) age-related macular degeneration |
664 |
622 |
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
3% |
1% |
Neovascular (wet) age-related macular degeneration |
664 |
622 |
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
1% |
<1% |
Diabetic macular edema |
1,262 |
625 |
|
<1% |
1% |
Neovascular (wet) age-related macular degeneration |
664 |
622 |
|
Drug (Faricimab) |
Comparator (Aflibercept) |
Indication |
Number of Patients (Faricimab) |
Number of Patients (Aflibercept) |
|---|---|---|---|---|
|
3% |
2% |
Diabetic macular edema |
1,262 |
625 |
|
3% |
2% |
Neovascular (wet) age-related macular degeneration |
664 |
622 |
<1%: Ophthalmic: Blurred vision, corneal abrasion, decreased visual acuity (transient), endophthalmitis, eye pruritus, foreign body sensation of eye, increased lacrimation, ocular hyperemia, retinal hole without detachment, rhegmatogenous retinal detachment
Hypersensitivity (eg, rash, pruritus, urticaria, erythema, severe intraocular inflammation) to faricimab or any component of the formulation; ocular or periocular infections; active intraocular inflammation.
Concerns related to adverse effects:
• Retinal vasculitis/retinal vascular occlusion: Cases of retinal vasculitis and/or retinal vascular occlusion have been reported with other vascular endothelial growth factor inhibitors (eg, brolucizumab) but not faricimab.
None known.
There are no known significant interactions.
Based on the mechanism of action, faricimab may affect fertility. Patients who may become pregnant should use effective contraception during treatment and for at least 3 months after the last dose of faricimab.
Based on the mechanism of action, in utero exposure to faricimab may cause fetal harm. Faricimab is a vascular endothelial growth factor (VEGF) inhibitor; VEGF is required to achieve and maintain normal pregnancies (Peracha 2016; Petri 2020).
It is not known if faricimab is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Intraocular pressure (via tonometry) and optic nerve head perfusion immediately following administration; symptoms of endophthalmitis and retinal detachment (eg, eye redness/pain, photophobia, blurred vision, other vision changes).
Faricimab is a recombinant humanized bispecific antibody that inhibits vascular endothelial growth factor A (VEGF-A), resulting in suppression of endothelial cell proliferation, neovascularization, and vascular permeability. Faricimab also inhibits angiopoietin-2 (Ang-2), which promotes vascular stability and desensitizes blood vessels to effects of VEGF-A.
Metabolism: Has not been fully characterized; expected to be catabolized in lysosomes to small peptides and amino acids.
Half-life elimination: 7.5 days.
Time to peak, plasma: ~2 days.
Excretion: Has not been fully characterized; metabolites may be excreted renally.
Solution (Vabysmo Intravitreal)
6 mg/0.05 mL (per 0.05 mL): $2,628.00
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