Aflibercept

Name: Aflibercept

Aflibercept Brand Names

Aflibercept may be found in some form under the following brand names:

  • Eylea

Aflibercept Drug Class

Aflibercept is part of the drug class:

  • Antineovascularisation agents

Aflibercept Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of aflibercept there are no specific foods that you must exclude from your diet when receiving aflibercept.

Side effects

The following potentially serious adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity [see CONTRAINDICATIONS]
  • Endophthalmitis and retinal detachments [see WARNINGS AND PRECAUTIONS]
  • Increase in intraocular pressure [see WARNINGS AND PRECAUTIONS]
  • Thromboembolic events [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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 2711 patients treated with EYLEA constituted the safety population in seven phase 3 studies. Among those, 2110 patients were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. The most common adverse reactions ( ≥ 5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.

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%
Ocular hyperemia 4% 8%
Corneal epithelium defect 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 Retinal Vein Occlusion (RVO)

The data described below reflect 6 months exposure to EYLEA with a monthly 2 mg dose in 218 patients following CRVO in 2 clinical studies (COPERNICUS and GALILEO) and 91 patients following BRVO in one clinical study (VIBRANT) [see Clinical Studies].

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

Adverse Reactions CRVO BRVO
EYLEA
(N=218)
Control
(N=142)
EYLEA
(N=91)
Control
(N=92)
Eye pain 13% 5% 4% 5%
Conjunctival hemorrhage 12% 11% 20% 4%
Intraocular pressure increased 8% 6% 2% 0%
Corneal epithelium defect 5% 4% 2% 0%
Vitreous floaters 5% 1% 1% 0%
Ocular hyperemia 5% 3% 2% 2%
Foreign body sensation in eyes 3% 5% 3% 0%
Vitreous detachment 3% 4% 2% 0%
Lacrimation increased 3% 4% 3% 0%
Injection site pain 3% 1% 1% 0%
Vision blurred 1% < 1% 1% 1%
Intraocular inflammation 1% 1% 0% 0%
Cataract < 1% 1% 5% 0%
Eyelid edema < 1% 1% 1% 0%

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

Diabetic Macular Edema (DME)

The data described below reflect exposure to EYLEA in 578 patients with DME treated with the 2-mg dose in 2 double-masked, controlled clinical studies (VIVID and VISTA) from baseline to week 52 and from baseline to week 100 [see Clinical Studies].

Table 3: Most Common Adverse Reactions ( ≥ 1%) in DME Studies

Adverse Reactions Baseline to Week 52 Baseline to Week 100
EYLEA
(N=578)
Control
(N=287)
EYLEA
(N=578)
Control
(N=287)
Conjunctival hemorrhage 28% 17% 31% 21%
Eye pain 9% 6% 11% 9%
Cataract 8% 9% 19% 17%
Vitreous floaters 6% 3% 8% 6%
Corneal epithelium defect 5% 3% 7% 5%
Intraocular pressure increased 5% 3% 9% 5%
Ocular hyperemia 5% 6% 5% 6%
Vitreous detachment 3% 3% 8% 6%
Foreign body sensation in eyes 3% 3% 3% 3%
Lacrimation increased 3% 2% 4% 2%
Vision blurred 2% 2% 3% 4%
Intraocular inflammation 2% < 1% 3% 1%
Injection site pain 2% < 1% 2% < 1%
Eyelid edema < 1% 1% 2% 1%

Less common adverse reactions reported in < 1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema, and injection site hemorrhage.

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, RVO, and DME studies, the pre-treatment incidence of immunoreactivity to EYLEA was approximately 1% to 3% across treatment groups. After dosing with EYLEA for 24-100 weeks, antibodies to EYLEA were detected in a similar percentage range of patients. There were no differences in efficacy or safety between patients with or without immunoreactivity.

Read the entire FDA prescribing information for Eylea (Aflibercept)

Read More »

In Summary

More frequently reported side effects include: increased intraocular pressure. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to aflibercept ophthalmic: intraocular solution

Ocular

Very common (10% or more): Conjunctival hemorrhage (28%), eye pain (13%),
Common (1% to 10%): Cataract, vitreous floaters, corneal erosion, intraocular pressure increased, conjunctival hyperemia, ocular hyperemia, vitreous detachment, foreign body sensation in eyes, lacrimation increased, vision blurred, intraocular inflammation, retinal pigment epithelium tear, injection site hemorrhage, eyelid edema, corneal edema, retinal degeneration, cataract, cataract nuclear, cataract subcapsular, corneal abrasion, intraocular pressure increased, vitreous floaters
Uncommon (0.1% to 1%): Retinal detachment, retinal tear, endophthalmitis injection site pain, traumatic cataract[Ref]

Local

Common (1% to 10%): Injection site pain[Ref]

Cardiovascular

Postmarketing reports:
Common (1% to 10%): Arterial thromboembolic events (ATEs) (such as nonfatal stroke, nonfatal myocardial infarction, or vascular death)[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Some side effects of aflibercept ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Aflibercept ophthalmic Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C Comments: -Women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last injection.

Aflibercept ophthalmic Breastfeeding Warnings

Use is not recommended. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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