Eylea

Eylea Dosage/Direction for Use

aflibercept

Manufacturer:

Bayer

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Aflibercept (Eylea) is for intravitreal injection.
It must only be administered by a qualified physician experienced in administering intravitreal injections.
Dosage regimen: Neovascular (wet) age-related macular degeneration (wet AMD): The recommended dose for Aflibercept (Eylea) is 2 mg (equivalent to 50 microliters).
Aflibercept (Eylea) treatment is initiated with one injection per month for three consecutive doses, followed by one injection every 2 months.
Based on the physician's judgement of visual and/or anatomic outcomes the treatment interval may be maintained at two months or further extended using a treat-and-extend dosing regimen, where injection intervals are gradually increased to maintain stable visual and/ or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
There is no requirement for monitoring between injections. Based on the physician's judgement the schedule of monitoring visits may be more frequent than the injections visits.
Aflibercept (Eylea) may be dosed as frequently as once per month (4 weeks).
Treatment intervals greater than 4 months (16 weeks) between injections have not been studied (see Pharmacology: Pharmacodynamics: Pharmacodynamic Effects under Actions).
Macular edema secondary to central retinal vein occlusion (CRVO): The recommended dose for Aflibercept (Eylea) is 2 mg (equivalent to 50 microliters).
After the initial injection, treatment is given monthly (every 4 weeks) until visual and/or anatomic outcomes are stable, three or more consecutive, monthly (every 4 weeks) injections may be needed. The interval between two doses should not be shorter than one month (4 weeks).
Treatment should be continued and the interval may be extended based on visual and anatomic outcomes (treat and extend regimen).
Macular edema secondary to branch retinal vein occlusion (BRVO): The recommended dose for Aflibercept (Eylea) is 2 mg (equivalent to 50 microliters).
After the initial injection, treatment is given monthly (every 4 weeks) until visual and/or anatomic outcomes are stable. Three or more consecutive, monthly (every 4 weeks) injections may be needed. The interval between two doses should not be shorter than one month (4 weeks).
Treatment should be continued and the interval may be extended based on visual and/or anatomic outcomes (treat and extend regimen).
Usually, monitoring should be done at the injection visits. During treatment interval extension through to completion of therapy, the monitoring schedule should be determined by the treating physician based on the individual patient's response and may be more frequent than the schedule of injections.
Diabetic macular edema (DME): The recommended dose for Aflibercept (Eylea) is 2 mg (equivalent to 50 microliters) administered by intravitreal injection monthly for the first 5 consecutive doses, followed by one injection every 2 months.
After the first 12 months of treatment with Aflibercept (Eylea), and based on visual and/or anatomic outcomes, the treatment interval may be extended, such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased to maintain stable based on visual and/or anatomic outcomes; however there are insufficient data to conclude on the length of these intervals. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
The schedule for monitoring should therefore be determined by the treating physician and may be more frequent than the schedule of injections.
If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Aflibercept (Eylea) should be discontinued.
Myopic choroidal neovascularization (myopic CNV): The recommended dose for Aflibercept (Eylea) is a single intravitreal injection of 2 mg (equivalent to 50 microliters).
Additional doses should be administered only if visual and anatomic outcomes indicate that the disease persists.
Additional information on special populations: Patients with hepatic and/or renal impairment: No specific studies in patients with hepatic and/or renal impairment have been conducted with Aflibercept (Eylea).
Available data do not suggest a need for a dose adjustment with Aflibercept (Eylea) in these patients.
Elderly: No special considerations are needed.
Method of administration: Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified physician experienced in administering intravitreal injections. In general, adequate anesthesia and asepsis, including topical broad spectrum microbicide (e.g., povidone iodine), have to be ensured. Surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) are recommended.
Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay.
Each vial should only be used for the treatment of a single eye.
After injection any unused product must be discarded.
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