Aflibercept

Pronunciation: a-FLIB-er-sept
Class: Selective vascular endothelial growth factor antagonist

Trade Names

Eylea
- Injection, intravitreal 40 mg/mL

Pharmacology

Binds to vascular endothelial growth factor A and placental growth factor, resulting in neovascularization and vascular permeability.

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Pharmacokinetics

Absorption

C _max is 0.02 mcg/mL (0 to 0.054 mcg/mL). T _max is 1 to 3 days.

Distribution

Vd is 6 L.

Elimination

Terminal elimination half-life is approximately 5 to 6 days.

Special Populations

No differences between patients with renal impairment and healthy renal function.

No studies have been conducted.

Indications and Usage

Treatment of neovascular (wet) age-related macular degeneration.

Contraindications

Active intraocular inflammation; hypersensitivity to any component of the product; ocular or periocular infection.

Dosage and Administration

Intravitreal 2 mg (0.05 mL) every 4 wk for the first 12 wk, followed by 2 mg (0.05 mL) once every 8 wk.

General Advice

• For ophthalmic intravitreal injection only.
• Withdraw all of the vial contents through the supplied filter needle attached to the supplied 1 mL syringe. Replace filter needle with the supplied 30-gauge × 1/2-inch needle for intravitreal injection.
• Expel contents until the plunger tip is aligned with the 0.05 mL mark on the syringe.
• Prior to the injection, give adequate anesthesia and broad-spectrum microbicide.
• Perform the intravitreal injection procedure under aseptic conditions, including use of sterile gloves, sterile drape, and a sterile eyelid speculum (or equivalent).
• Use each vial 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 aflibercept is administered to the other eye.

Storage/Stability

Store between 36° and 46°F. Do not freeze. Protect from light. Store in original carton until use. Discard any unused product.

Drug Interactions

None well documented.

Adverse Reactions

Cardiovascular

Arterial thromboembolic events (2%).

EENT

Conjunctival hemorrhage (25%); eye pain (9%); cataract (7%); vitreous detachment, vitreous floaters (6%); increased IOP (5%); conjunctival hyperemia, corneal erosion (4%); detachment of the retinal pigment epithelium, foreign body sensation in eye, increased lacrimation, injection-site pain (3%); retinal pigment epithelium tear, vision blurred (2%); corneal edema, eyelid edema, injection-site hemorrhage (1%); endophthalmitis; retinal detachment.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Endophthalmitis and retinal detachments

May occur.

Increased IOP

May occur within 60 min of intravitreal injection.

Thromboembolic effects

Arterial thromboembolic events (eg, nonfatal MI, nonfatal stroke, vascular death) may occur.

Overdosage

Symptoms

No data available.

Patient Information

• Advise patient to seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light, or painful, or if the patient develops a change in vision.
• Inform patients that they may experience a temporary visual disturbance after injection and the associated eye exams. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

Copyright © 2009 Wolters Kluwer Health.