Note: Ocular hypotensive medications may be administered if needed to lower intraocular pressure prior to administration.
Geographic atrophy: Intravitreal: 2 mg (0.1 mL) into affected eye(s) once monthly (~every 21 to 35 days) for up to 12 months.
No dosage adjustment necessary.
No dosage adjustment necessary.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%: Ophthalmic: Conjunctival hemorrhage (13%)
1% to 10%: Ophthalmic: Blepharitis (2%), blurred vision (8%; including decreased visual acuity and visual impairment), eye pain (4%), increased intraocular pressure (9%), subretinal neovascularization (7%), vitreous opacity (2%)
Ocular or periocular infections; active intraocular inflammation.
Concerns related to adverse effects:
• Endophthalmitis/retinal detachment: Intravitreous injections are associated with endophthalmitis and retinal detachments. Use proper aseptic injection techniques. Instruct patients to report any signs of endophthalmitis (eg, eye pain or redness, photophobia, blurred vision) immediately; manage appropriately.
• Increased intraocular pressure: Following intravitreal injection, intraocular pressure may increase.
• Neovascular age-related macular degeneration: Neovascular (wet) age-related macular degeneration and choroidal neovascularization have been reported.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal [preservative free]:
Izervay: 2 mg/0.1 mL (0.1 mL)
No
Solution (Izervay Intravitreal)
2MG/0.1ML (per 0.1 mL): $2,520.00
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Intravitreal: For ophthalmic intravitreal injection only under controlled aseptic conditions. Each vial is used for the treatment of a single eye. Inject slowly until the full 0.1 mL is delivered. Should be administered using a 30-gauge ½-inch sterile needle. 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 avacincaptad pegol is administered to the other eye. Adequate anesthesia and a topical broad-spectrum antimicrobial agent should be administered prior to the procedure.
Geographic atrophy: Treatment of geographic atrophy secondary to age-related macular degeneration.
None known.
There are no known significant interactions.
Adverse events were not observed in animal developmental studies following IV administration of avacincaptad pegol to rats and rabbits in doses equivalent to 5.1 and 3.2 the maximum recommended human dose, respectively, based on AUC.
It is not known if avacincaptad pegol 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 using tonometry prior to and immediately following injection; optic nerve head perfusion; signs/symptoms of endophthalmitis or retinal detachment; signs of neovascular age-related macular degeneration or choroidal neovascularization.
Avacincaptad pegol is an RNA aptamer, a PEGylated oligonucleotide that binds to and inhibits complement protein C5 thereby preventing the cleavage to C5a and C5b and decreasing membrane attack complex (MAC) formation.
Metabolism: Metabolized by catabolic pathways into smaller oligonucleotides.
Half-life elimination: ~12 days.
Time to peak: ~7 days.
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