Izervay (avacincaptad pegol sodium/PF)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Avacincaptad pegol sodium, a pegylated ribonucleic acid (RNA) aptamer, is a complement C5 inhibitor.
Avacincaptad pegol sodium is a complement inhibitor that binds with high affinity and specificity to complement C5; the drug is an RNA aptamer, covalently bound to a branched polyethylene glycol (PEG) molecule. Although the pathophysiology of geographic atrophy is not fully understood, the complement system is thought to play a role. Complement C5 is a central component of the complement system that acts near the terminal end of the complement cascade, promoting inflammation and cell death; by inhibiting complement C5, avacincaptad pegol may prevent formation of the key terminal fragments (C5a and C5b) involved in these processes, thus decreasing membrane attack complex formation and potentially the progression of retinal cell degeneration.
Following a single intravitreal injection of avacincaptad pegol, peak plasma concentrations are achieved in approximately 7 days. Metabolism and elimination has not been fully characterized. Avacincaptad pegol is expected to be catabolized by endonucleases and exonucleases to oligonucleotides of shorter lengths, which may be excreted renally.
The estimated apparent systemic half-life is approximately 12 days.
USES: Avacincaptad pegol is used to treat a certain serious eye condition (geographic atrophy). It may help delay vision loss. Avacincaptad pegol works by helping to block your immune system from destroying cells in your eye.
Generic name: avacincaptad pegol sodium/PF
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Izervay:
- Nonexudative Age-Related Macular Degeneration
Also known as: Geographic Atrophy Due To Age-Related Macular Degeneration.
Dosing
Dosage of avacincaptad pegol sodium is expressed in terms of avacincaptad pegol.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Formal drug interaction studies have not been conducted with avacincaptad pegol.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Ocular or periocular infections.
*Active intraocular inflammation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions reported with avacincaptad pegol in clinical studies were conjunctival hemorrhage (13%), increased IOP (9%), blurred vision (8%), and neovascular age-related macular degeneration (7%).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
The safety and efficacy of avacincaptad pegol in pediatric patients have not been established.
There are no adequate data regarding the use of avacincaptad pegol in pregnant women. Use of avacincaptad pegol in pregnancy may be considered following an assessment of the risks and benefits. No maternal or embryofetal adverse effects were observed in animal studies; however, in rat studies, an increase in the incidence of non-adverse skeletal variation, described as short thoracolumbar supernumerary ribs was observed.
It is not known whether avacincaptad pegol is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for avacincaptad pegol, and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.
Dosage adjustments are not needed in geriatric patients.
Among the patients who received avacincaptad pegol in clinical studies, 90% were >=65 years of age and 61% were >=75 years of age. No differences in efficacy or safety of avacincaptad pegol were observed with increasing age, and no dosage adjustments are recommended based on age.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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