aflibercept intravitreal (Rx)Brand and Other Names:Eylea

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal injectable solution

  • 40mg/mL
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Macular Degeneration

Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD)

2 mg (0.05 mL) by intravitreal injection q4wk for the first 3 injections, followed by 2 mg q8wk

Additional efficacy was not demonstrated for continuation therapy when dosed once monthly compared to q2months

Some patients may need q4wk (monthly) dosing after first 20 weeks (5 months)

Macular Edema

Indicated for treatment of macular edema following retinal vein occlusion (branched or central retinal vein occlusion)

2 mg (0.05 mL) by intravitreal injection q4wk

Diabetic Macular Edema

2 mg (0.05 mL or 50 microliters) administered by intravitreal injection q4wk for the first 5 injections, followed by 2 mg q8wk

May be dosed as frequently as 2 mg q4wk; however, additional efficacy was not demonstrated when dosed q4wk compared to q8wk

Some patients may need q4wk (monthly) dosing after first 20 weeks (5 months)

Diabetic Retinopathy with DME

Indicated for diabetic retinopathy in patients with diabetic macular edema (DME)

2 mg (0.05 mL or 50 microliters) administered by intravitreal injection q4wk for the first 5 injections, followed by 2 mg q8wk

May be dosed as frequently as 2 mg q4wk; however, additional efficacy was not demonstrated when dosed q4wk compared to q8wk

Some patients may need q4wk (monthly) dosing after first 20 weeks (5 months)

Safety and efficacy not established

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Adverse Effects

>10%

Conjunctival hemorrhage (25%)

Eye pain (9-13%)

1-10%

Cataract (7%)

Vitreous floaters (6%)

Increased IOP (5%)

Conjunctival hyperemia (4%)

Corneal erosion (4%)

Retinal pigment epithelium detachment (3%)

Injection site pain (3%)

Foreign body sensation in eyes (3%)

Lacrimation increased (3%)

Blurred vision (2%)

Retinal pigment epithelium tear (2%)

Injection site hemorrhage (1%)

Eyelid edema (1%)

Corneal edema (1%)

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Warnings

Contraindications

Hypersensitivity

Ocular or periocular infection

Active intraocular inflammation

Cautions

Edophthalmitis and retinal detachments reported with intravitreal injections

Acute increases in intraocular pressure have been observed within 60 minutes of intravitreal injection

Potential risk of arterial thromboembolic events (eg, nonfatal stroke, nonfatal myocardial infarction, or vascular death) following intravitreal use of VEGF inhibitors (incidence over 1 yr varies depending on the study ranging from 0% to 3.3%)

Hypersensitivity reactions may present as severe intraocular inflammation

Females of reproductive potential should use effective contraception prior to initial dose, during treatment, and for at least 3 months after last intravitreal injection

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Pregnancy & Lactation

Pregnancy Category: C

Produced embryo-fetal toxicity when administered q3 days during organogenesis to pregnant rabbits at IV of 3 mg/kg or greater, or q6 days at SC of 0.1 mg/kg or greater

Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was <0.1 mg/kg

Administration of the lowest dose assessed in rabbits resulted in systemic exposure (AUC) that was approximately 10 times the systemic exposure observed in humans after an intravitreal dose of 2 mg

Lactation: Unknown whether distributed in breast milk; not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Binds and prevents activation of vascular endothelial growth factors (VEGF-A) and placental growth factor (PIGF)

Activation of VEGF-A and PIGF can result in neovascularization and vascular permeability

Absorption

Peak plasma time: 1-3 days

Peak plasma concentration: 0.02 mcg/mL

Distribution

Vd: 6 L

Elimination

Half-life: 5-6 days

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Administration

Intravitreal Injection Preparation

Vial contains 0.278 mL of 40 mg/mL solution

Use provided 5-micron filter needle

Using aseptic technique, withdraw all contents of vial (keep vial in upright position, slightly inclined to ease complete withdrawal)

Remove and discard filter needle

Replace needle with 30-gauge x 0.5-inch needle (provided in kit)

Gently tap syringe to remove bubbles

To eliminate all of the bubbles and to expel excess drug, slowly depress the plunger to the plunger tip aligns with the 0.05 mL measurement line

Each vial should only be used for a single eye

Storage

Refrigerate unopened vials at 2-8°C (36-46°F); do not freeze

Protect from light

Store in the original carton until time of use

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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