- What is Eylea (aflibercept) and how is it used?
- What are the most important side effects and other facts about Vyxeos (daunorubicin and cytarabine)?
- Other side effects of Eylea (aflibercept)
- What is the dosage for Eylea (aflibercept)?
- Eylea (aflibercept) contraindications, pregnancy safety and drug interactions
What is Eylea (aflibercept) and how is it used?
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:
What are the most important side effects and other facts about Vyxeos (daunorubicin and cytarabine)?
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.
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).
Other side effects of Eylea (aflibercept)
The most common side effects of Eylea include:
- conjunctival hemorrhage,
- eye pain,
- 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.
What is the dosage for Eylea (aflibercept)?
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 (aflibercept) contraindications, pregnancy safety and drug interactions
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:
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 prior to 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.
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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), and Diabetic Retinopathy (DR). The most common side effects of Eylea include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
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Eye strain is a symptom caused by looking at something for a long time. Symptoms and signs include redness, light sensitivity, headaches, and blurred vision. Symptoms may be treated by closing the eyes and taking a break from the visual task.
Eye floaters are deposits or condensation that forms in the eye's vitreous humor. These deposits cast shadows on the retina, and as the eye moves, the deposits shift position, making it appear as though the shadows are moving or floating.
Age-related macular degeneration (AMD) is a disease that gradually destroys the central vision. In people over 60, AMD is a leading cause of vision loss. Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula, leaking blood and fluid and causing rapid vision loss. In dry AMD, light-sensitive cells slowly break down in the macula, resulting in gradual vision loss. Pain is not associated with either form of AMD.
Macular Degeneration (Age-Related Type)
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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.