aflibercept

Eylea is a prescription medication for retinal diseases, which is administered by injection into the eye. 

Eylea is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: 

• Neovascular (Wet) Age-Related Macular Degeneration (AMD) 
• Macular Edema Following Retinal Vein Occlusion (RVO) 
• Diabetic Macular Edema (DME) 
• Diabetic Retinopathy (DR) 

Endophthalmitis and Retinal Detachments 

Intravitreal injections, including those with Eylea, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering Eylea. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Increase in Intraocular Pressure 

Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with Eylea. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events

There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including Eylea. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

The most common side effects of Eylea include: 

• conjunctival hemorrhage,
• eye pain,
• cataract,
• vitreous detachment,
• vitreous floaters, and
• intraocular pressure increased. 

To report suspected adverse reactions, contact Regeneron at 1-855-395-3248 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

The recommended dose for Eylea is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months).

Although Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months). 

Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly. 

Macular Edema Following Retinal Vein Occlusion (RVO)

The recommended dose for Eylea is 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly). 

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) 

The recommended dose for Eylea is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). 

Although Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). 

Eylea is contraindicated in patients with: 

• ocular or periocular infections, 
• active intraocular inflammation, and
• known hypersensitivity to aflibercept or any of the excipients in Eylea. Hypersensitivity reactions may manifest as:
  • rash,
  • pruritus,
  • urticaria,
  • severe anaphylactic/anaphylactoid reactions, or
  • severe intraocular inflammation.

Adequate and well-controlled studies with Eylea have not been conducted in pregnant women. 

There is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, Eylea is not recommended during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Eylea and any potential adverse effects on the breastfed child from Eylea.

Females of reproductive potential are advised to use effective contraception before the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of Eylea. 

There are no data regarding the effects of Eylea on human fertility. 

The safety and effectiveness of Eylea in pediatric patients have not been established.

No significant differences in efficacy or safety were seen with increasing age in patients older than 65 years of age.