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Eylea

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Eylea

Eylea Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Eylea (aflibercept) is a recombinate protein indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD). AMD is a common cause of blindness. Eylea is not available as a generic drug. The most common side effects from the use of Eylea are conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Eylea is supplied as a preservative-free, sterile, aqueous solution in a single-use, glass vial designed to deliver 0.05 mL (50 microliters) of Eylea in the strength of 40 mg/ml. Eylea is injected into the eye either every four weeks or every eight weeks by an ophthalmologist. The recommended dose for Eylea is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks(monthly) for the first 12 weeks (3 months), followed by 2 mg(0.05 mL) via intravitreal injection once every 8 weeks (2 months). Eylea should not be used in those who have an active eye infection or active ocular inflammation. Eylea has not been studied in pregnant women, so the treatment should be used only in pregnant women if the potential benefits of the treatment outweigh any potential risks. Age related macular degeneration does not occur in children and Eylea has not been studied in children.

Our Eylea (aflibercept) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Eylea in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • eye pain or redness, swelling around your eyes;
  • sudden vision problems;
  • seeing flashes of light or "floaters" in your vision;
  • eyes being more sensitive to light;
  • sudden numbness or weakness, especially on one side of the body; or
  • sudden severe headache, confusion, problems with speech or balance.

Less serious side effects may include:

  • watery eyes;
  • blurred vision;
  • swelling of the eyelids; or
  • mild eye pain or discomfort after the injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Eylea (Aflibercept) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Eylea FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS section of the labeling:

The most common adverse reactions ( ≥ 5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Injection Procedure

Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections with EYLEA including endophthalmitis, traumatic cataract, increased intraocular pressure, and vitreous detachment.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice.

A total of 2042 patients treated with EYLEA constituted the safety population in four phase 3 studies. Among those, 1441 patients were treated with the recommended dose of 2 mg.

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

The data described below reflect exposure to EYLEA in 1824 patients with wet AMD, including 1223 patients treated with the 2-mg dose, in 2 double-masked, active-controlled clinical studies (VIEW1 and VIEW2) for 12 months [see Clinical Studies].

Table 1: Most Common Adverse Reactions ( ≥ 1%) in Wet AMD Studies

Adverse Reactions EYLEA
(N=1824)
Active Control (ranibizumab)
(N=595)
Conjunctival hemorrhage 25% 28%
Eye pain 9% 9%
Cataract 7% 7%
Vitreous detachment 6% 6%
Vitreous floaters 6% 7%
Intraocular pressure increased 5% 7%
Conjunctival hyperemia 4% 8%
Corneal erosion 4% 5%
Detachment of the retinal pigment epithelium 3% 3%
Injection site pain 3% 3%
Foreign body sensation in eyes 3% 4%
Lacrimation increased 3% 1%
Vision blurred 2% 2%
Intraocular inflammation 2% 3%
Retinal pigment epithelium tear 2% 1%
Injection site hemorrhage 1% 2%
Eyelid edema 1% 2%
Corneal edema 1% 1%

Less common serious adverse reactions reported in < 1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, and endophthalmitis.

Macular Edema Following Central Retinal Vein Occlusion (CRVO)

The data described below reflect exposure to EYLEA in 218 patients with macular edema following CRVO treated with 2 mg dose in 2 double-masked, controlled clinical studies (GALILEO and COPERNICUS) for 6 months [see Clinical Studies].

Table 2: Most Common Adverse Reactions ( ≥ 1%) in CRVO Studies

Adverse Reactions EYLEA
(N=218)
Control
(N=142)
Eye pain 13% 5%
Conjunctival hemorrhage 12% 11%
Intraocular pressure increased 8% 6%
Corneal erosion 5% 4%
Vitreous floaters 5% 1%
Conjunctival hyperemia 5% 3%
Foreign body sensation in eyes 3% 5%
Vitreous detachment 3% 4%
Lacrimation increased 3% 4%
Injection site pain 3% 1%
Vision blurred 1% < 1%
Intraocular inflammation 1% 1%

Less common adverse reactions reported in < 1% of the patients treated with EYLEA were cataract, eyelid edema, corneal edema, retinal tear, hypersensitivity and endophthalmitis.

Immunogenicity

As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA. The immunogenicity of EYLEA was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to EYLEA in immunoassays. The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to EYLEA with the incidence of antibodies to other products may be misleading.

In the wet AMD and CRVO studies, the pre-treatment incidence of immunoreactivity to EYLEA was 1% to 3% across treatment groups. After dosing with EYLEA for 52 weeks (wet AMD), or 24 weeks (CRVO), antibodies to EYLEA were detected in a similar percentage range of patients. Both in the wet AMD and in the CRVO studies, there were no differences in efficacy or safety between patients with or without immunoreactivity.

Read the entire FDA prescribing information for Eylea (Aflibercept) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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