Eylea

Name: Eylea

Eylea 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 Eylea there are no specific foods that you must exclude from your diet when receiving Eylea.

Eylea Usage

Eylea comes as a liquid to be injected into the eye by a healthcare provider in a medical office, hospital, or clinic.

Before you receive an Eylea injection, your eye will be cleansed to prevent infection and numbed to reduce discomfort during the injection. You may feel pressure in your eye when the medication is injected. You should feel no pain.

After your injection, your doctor will need to examine your eyes before you leave the office.

You may receive a prescription for antibiotic eye drops to prevent infection after the procedure.

After receiving an Eylea injection you may experience temporary vision problems. Do not drive or operate machinery until your vision has returned to normal.

Cautions for Eylea

Contraindications

  • Ocular or periocular infections.1

  • Active intraocular inflammation.1

  • Known hypersensitivity (e.g., severe intraocular inflammation) to aflibercept or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions reported.1 (See Contraindications under Cautions.)

Endophthalmitis and Retinal Detachment

Intravitreal injections, including with aflibercept, associated with endophthalmitis and retinal detachment.1 Always use proper aseptic injection technique.1

If signs or symptoms of endophthalmitis or retinal detachment (e.g., redness, sensitivity to light, pain, changes in vision [including blurred vision]) occur, manage appropriately.1

Increased IOP

Acute increases in IOP observed within 60 minutes of intravitreal injection.1 Sustained increases in IOP also observed following repeated intravitreal injections of VEGF antagonists.1 Monitor IOP and perfusion of optic nerve head and manage appropriately.1

Thromboembolic Events

Potential risk of arterial thromboembolic events following intravitreal injection of VEGF antagonists, including aflibercept.1

Immunogenicity

Incidence of immunoreactivity to aflibercept was similar before and after 24–100 weeks of therapy.1 No differences in efficacy or safety between patients with or without immunoreactivity.1

Specific Populations

Pregnancy

Category C.1

No adequate and well-controlled studies in pregnant women.1 Animal studies suggest a possibility of adverse embryofetal effects.1

Use only if potential benefits justify potential risk to fetus.1 Women of childbearing potential should use effective contraception prior to initiating therapy, during treatment, and for ≥3 months after last intravitreal injection is administered.1

Lactation

Not known whether aflibercept is distributed into milk.1 Use not recommended in nursing women.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults.1

Renal Impairment

No differences in plasma concentrations observed with various degrees of renal impairment.1 (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Conjunctival hemorrhage,1 2 3 eye pain,1 2 3 cataract,1 vitreous detachment,1 2 3 vitreous floaters,1 2 increased IOP.1 2 3

Eylea Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Blindness
  • bloody eye
  • blurred vision
  • eye or eyelid redness
  • eye pain
  • seeing flashes, sparks of light, or a veil or curtain
  • seeing floating spots before the eyes
  • vision changes
Less common
  • Bleeding or pain at the injection site
  • swelling of the eyelid
Rare
  • Fast heartbeat
  • fever
  • headache
  • hives, itching, rash, or skin redness
  • hoarseness
  • joint pain, stiffness, or swelling
  • swelling of the face, lips, hands, or feet
  • troubled breathing or swallowing
Incidence not known
  • Pain in the chest, groin, or legs, especially the calves
  • severe, sudden headache
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Feeling like something is in the eye
  • watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Eylea?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Adverse Reactions

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

  • Hypersensitivity [see Contraindications (4.3)]
  • Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1)]
  • Increase in intraocular pressure [see Warnings and Precautions (5.2)]
  • Thromboembolic events [see Warnings and Precautions (5.3)]

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 (14.1)].

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 (14.2), (14.3)].

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 (14.4)].

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.

Eylea Description

Eylea (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.

Eylea is a sterile, clear, and colorless to pale yellow solution. 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 (40 mg/mL in 10 mM sodium phosphate, 40 mM sodium chloride, 0.03% polysorbate 20, and 5% sucrose, pH 6.2).

How Supplied/Storage and Handling

Each Vial is for single eye use only. Eylea is supplied in the following presentation [see Dosage and Administration (2.6) and (2.7)].

NDC NUMBER CARTON TYPE CARTON CONTENTS
61755-005-02 Vial one single-use, sterile, 3-mL, glass vial designed to deliver 0.05 mL of 40 mg/mL Eylea
one 19-gauge × 1½-inch, 5-micron, filter needle for withdrawal of the vial contents
one 30-gauge × ½-inch injection needle for intravitreal injection
one 1-mL syringe for administration
one package insert

Storage

Eylea should be refrigerated at 2°C to 8ºC (36°F to 46ºF). Do Not Freeze. Do not use beyond the date stamped on the carton and container label. Protect from light. Store in the original carton until time of use.

Before using Eylea

You should not use Eylea if you are allergic to aflibercept, or if you have:

  • swelling inside your eyes; or

  • any type of bacterial, fungal, or viral infection in or around your eyes.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • a blood clot or stroke; or

  • glaucoma or other condition that increase pressure inside your eyes.

It is not known whether Eylea will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Eylea. Use effective birth control to prevent pregnancy before your first dose of this medicine. Keep using birth control for at least 3 months after your last injection.

It is not known whether aflibercept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Eylea.

How is Eylea given?

Eylea is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Eylea is usually given once every 4 weeks for the first 3 months, and then once every 8 weeks. Follow your doctor's dosing instructions very carefully.

What should I avoid?

Eylea may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Eylea side effects

Get emergency medical help if you have any signs of an allergic reaction to Eylea: hives; difficult breathing; swelling of your eyes, 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, seeing halos around lights;

  • increased sensitivity of your eyes 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 Eylea side effects may include:

  • red or 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.

In Summary

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

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