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Avacincaptad pegol: Drug information

Avacincaptad pegol: Drug information
(For additional information see "Avacincaptad pegol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Izervay
Pharmacologic Category
  • Complement C5 Inhibitor;
  • Complement Inhibitor;
  • Ophthalmic Agent
Dosing: Adult

Note: Ocular hypotensive medications may be administered if needed to lower intraocular pressure prior to administration.

Geographic atrophy

Geographic atrophy: Intravitreal: 2 mg (0.1 mL) into affected eye(s) once monthly (~every 21 to 35 days) for up to 12 months.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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%)

Contraindications

Ocular or periocular infections; active intraocular inflammation.

Warnings/Precautions

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.

Dosage Forms: US

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)

Generic Equivalent Available: US

No

Pricing: US

Solution (Izervay Intravitreal)

2MG/0.1ML (per 0.1 mL): $2,520.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Use: Labeled Indications

Geographic atrophy: Treatment of geographic atrophy secondary to age-related macular degeneration.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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.

Breastfeeding Considerations

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.

Monitoring Parameters

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.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Metabolism: Metabolized by catabolic pathways into smaller oligonucleotides.

Half-life elimination: ~12 days.

Time to peak: ~7 days.

  1. Izervay (avacincaptad pegol) [prescribing information]. Parsippany, NJ: Iveric bio, Inc; August 2023.
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