Eylea 40 mg/mL Solution for Injection

EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)

• Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week
• Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses
• These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days)
• Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes
• Diabetic Macular Edema (DME) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week
• Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses
• These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days)
• Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes. …

EYLEA HD is a clear to slightly opalescent, colorless to pale yellow solution available as: Injection: 8 mg (0.07 mL of a 114.3 mg/mL solution) in a single-dose glass vial Injection: 8 mg (0.07 mL of 114.3 mg/mL solution) in a single-dose vial ( 3 )

• The safety and effectiveness of EYLEA HD
• In pediatric patients have not been established

In the clinical studies, approximately 66% (1156/1755) of the patients in the HD groups were 65 years of age or older and approximately 31% (543/1755) of the patients were 75 years of age or older. No overall differences in safety or effectiveness of EYLEA HD have been observed.

• In the days following EYLEA HD administration, patients are at risk of developing endophthalmitis, retinal detachment, or retinal vasculitis with or without occlusion
• If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients and/or caregivers to seek immediate care from an ophthalmologist [see Warnings and Precautions ]
• Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD and the associated eye examinations [see Adverse Reactions ]
• Advise patients not to drive or use machinery until visual function has recovered sufficiently

• Ocular or periocular infection Active intraocular inflammation Hypersensitivity Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections
• Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation
• Hypersensitivity EYLEA HD is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA HD. …

Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. …

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters …

8.1 Pregnancy Risk Summary Adequate and well-controlled studies with EYLEA HD have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. A fetal No Observed Adverse Effect Level (NOAEL) was not identified. …

Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdosage, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.

Refrigerate EYLEA HD at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.