AMD)
1.2 Macular Edema Following Retinal Vein Occlusion (RVO)
1.3 Diabetic Macular Edema (DME)
1.4 Diabetic Retinopathy (DR) in Patients with DME
2 DOSAGE AND ADMINISTRATION
2.1 Important Injection Instructions
2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD)
2.3 Macular Edema Following Retinal Vein Occlusion (RVO)
2.4 Diabetic Macular Edema (DME)
2.5 Diabetic Retinopathy (DR) in Patients with DME
2.6 Preparation for Administration
2.7 Injection Procedure
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
4.2 Active Intraocular Inflammation
4.3 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Endophthalmitis and Retinal Detachments
5.2 Increase in Intraocular Pressure
5.3 Thromboembolic Events
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD)
14.2 Macular Edema Following Central Retinal Vein Occlusion (CRVO)
14.3 Macular Edema Following Branch Retinal Vein Occlusion (BRVO)
14.4 Diabetic Macular Edema (DME)
14.5 Diabetic Retinopathy (DR) in Patients with DME
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
EYLEA is indicated for the treatment of:
1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD)
1.2 Macular Edema Following Retinal Vein Occlusion (RVO)
1.3 Diabetic Macular Edema (DME)
1.4 Diabetic Retinopathy (DR) in Patients with DME
2 DOSAGE AND ADMINISTRATION
2.1 Important Injection Instructions
For ophthalmic intravitreal injection. EYLEA must only be administered by a qualified physician.
2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD)
The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (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 (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks [see CLINICAL STUDIES (14.1)]. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).
2.3 Macular Edema Following Retinal Vein Occlusion (RVO)
The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection once every 4 weeks (monthly) [see CLINICAL STUDIES (14.2), (14.3)].
2.4 Diabetic Macular Edema (DME)
The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (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 (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks [see |
