Introduction

Avacincaptad pegol sodium, a ribonucleic acid (RNA) aptamer covalently bound to a polyethylene glycol (PEG) molecule, is a complement C5 inhibitor.

Uses for Avacincaptad Pegol (EENT)

Avacincaptad pegol has the following uses:

Avacincaptad pegol intravitreal solution is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Avacincaptad Pegol (EENT) Dosage and Administration

General

Avacincaptad pegol sodium is available in the following dosage form(s) and strength(s):

Intravitreal solution: 20 mg/mL (of avacincaptad pegol) in a single-dose vial

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

The recommended dose for avacincaptad pegol is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately 28 ± 7 days) for up to 12 months.

Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial and syringe should be used.

Administer under controlled aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad spectrum topical microbicide should be given prior to the injection.. See Full Prescribing Information for additional instructions on preparation and administration of the drug.

Monitor for elevated intraocular pressure (IOP) prior to and immediately following the intravitreal injection.

Contraindications

• Ocular or periocular infections.

• Active intraocular inflammation.

Warnings/Precautions

Endophthalmitis and Retinal Detachments

Intravitreal injections may be associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering avacincaptad pegol in order to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Neovascular Age-related Macular Degeneration (AMD)

In clinical trials, use of avacincaptad pegol was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12. Patients receiving avacincaptad pegol should be monitored for signs of neovascular AMD.

Increase in Intraocular Pressure

Transient increases in intraocular pressure (IOP) have been observed after an intravitreal injection, including with avacincaptad pegol. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

Specific Populations

Pregnancy

There are no adequate and well-controlled studies of avacincaptad pegol administration in pregnant women. The use of avacincaptad pegol may be considered following an assessment of the risks and benefits.

Administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at IV doses 5.1 times and 3.2 times the human exposure (based on AUC) at the maximum recommended human dose (MRHD) of 2 mg once monthly, respectively.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15%-20%, respectively.

Lactation

There is no information regarding the presence of avacincaptad pegol in human milk, the effects of the drug on the breastfed infant, or the effects of avacincaptad pegol on milk production. Many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breastfed child.

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 avacincaptad pegol.

Pediatric Use

Safety and effectiveness of avacincaptad pegol in pediatric patients have not been established.

Geriatric Use

Of the total number of patients who received avacincaptad pegol in the two pivotal clinical trials, 90% (263/292) were ≥65 years of age and 61% (178/292) were ≥75 years of age. No significant differences in efficacy or safety of avacincaptad pegol were seen with increasing age in these studies. No dose adjustment is required in patients 65 years of age and older.

Common Adverse Effects

The most common adverse reactions were conjunctival hemorrhage (13%), increased IOP (9%), blurred vision (8%) and neovascular age-related macular degeneration (7%).

General

Avacincaptad pegol sodium is available in the following dosage form(s) and strength(s):

Intravitreal solution: 20 mg/mL (of avacincaptad pegol) in a single-dose vial

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

The recommended dose for avacincaptad pegol is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately 28 ± 7 days) for up to 12 months.

Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial and syringe should be used.

Administer under controlled aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad spectrum topical microbicide should be given prior to the injection.. See Full Prescribing Information for additional instructions on preparation and administration of the drug.

Monitor for elevated intraocular pressure (IOP) prior to and immediately following the intravitreal injection.