Eylea Hd Generic Name & Formulations
Kit (Eylea, Eylea HD)—1 (single-use vial w. supplies); Single-use prefilled syringe (Eylea)—1; Single-use vial (Eylea HD)—1
Eylea HD is supplied as either:
A single-dose glass vial containing one Eylea HD 8 mg (0.07 mL of a 114.3 mg/mL solution); or
A vial kit with the following components: one Eylea HD 8 mg (0.07 mL of a 114.3 mg/mL solution) single-dose glass vial; one 18-gauge x 1½-inch, 5-micron, filter needle for withdrawal of the vial contents; one 30-gauge x ½-inch injection needle for intravitreal injection; and one 1-mL syringe for administration.
Refrigerate Eylea HD at 2°C to 8ºC (36°F to 46ºF). 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.
Mechanism of Action
Eylea Hd Indications
Neovascular (wet) age-related macular degeneration (AMD). Diabetic macular edema (DME). Diabetic retinopathy (DR).
Eylea Hd Dosage and Administration
Give by intravitreal injection. AMD, DME: 8mg (0.07mL) once every 4 weeks (approx. every 28 days ± 7 days) for the 1st 3 doses, followed by 8mg (0.07mL) once every 8–16 weeks (± 1 week). DR: 8mg (0.07mL) once every 4 weeks (approx. every 28 days ± 7 days) for the 1st 3 doses, followed by 8mg (0.07mL) once every 8–12 weeks (± 1 week).
Eylea Hd Contraindications
Eylea Hd Boxed Warnings
Eylea Hd Warnings/Precautions
Must only be administered by a qualified physician. Evaluate if endophthalmitis or retinal detachment occurs. Monitor intraocular pressure and perfusion of optic nerve head after injection. Potential risk for arterial thromboembolic events (eg, nonfatal stroke or MI, vascular death). In ROP (Eylea only): reactivation of abnormal angiogenesis and tortuosity may occur after treatment; monitor infants closely until retinal vascularization has completed or until assurance that reactivation will not occur; may need extended monitoring, additional Eylea inj and/or laser treatments. Pregnancy. Advise females of reproductive potential to use effective contraception prior to initial dose, during therapy, and for at least 3 months (Eylea) and for at least 4 months (Eylea HD) after last injection. Nursing mothers: not recommended.
Endophthalmitis and Retinal Detachments
Must always use proper aseptic injection technique during administration. Instruct patients to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and manage appropriately.
Increase in Intraocular Pressure
Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with Eylea HD. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors.
Monitor intraocular pressure and the perfusion of the optic nerve head and manage appropriately.
Risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including Eylea HD. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
There were no reported thromboembolic events in the patients treated with Eylea HD in the first six months of the RVO studies.
No adequate and well-controlled studies with Eylea HD have been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. Based on the anti-VEGF mechanism of action for aflibercept, treatment with Eylea HD may pose a risk to human embryofetal development.
Only use Eylea HD during pregnancy if the potential benefit justifies the potential risk to the fetus.
Nursing Mother Considerations
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.
Eylea HD is not recommended to use during breastfeeding due to the potential risk for absorption and harm to infant growth and development.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Eylea HD and any potential adverse effects on the breastfed child from Eylea HD.
The safety and effectiveness of Eylea HD in pediatric patients have not been established.
Other Considerations for Specific Populations
Females and Males of Reproductive Potential
Contraception: Advise to use effective contraception prior to the initial dose, during treatment, and for at least 4 months after the last intravitreal injection of Eylea HD.
Infertility: There are no data regarding the effects of Eylea HD on human fertility.
Eylea Hd Pharmacokinetics
Following unilateral intravitreal administration of 8 mg aflibercept, the mean (SD) Cmax of free aflibercept in plasma was 0.30 (0.27) mg/L, and the median time to maximal concentration in plasma was 2.9 days. The accumulation of free aflibercept in plasma following three initial monthly intravitreal doses was minimal (mean accumulation ratio 1.2); subsequently, no further accumulation was observed.
The volume of distribution of free aflibercept following intravenous administration of aflibercept is ~7 L.
The median time to reach non-quantifiable concentrations of free aflibercept in plasma for 8 mg administered intravitreally was 3.5 weeks.
Eylea Hd Interactions
Eylea Hd Adverse Reactions
Eylea Hd Clinical Trials
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
The approval was based on data from the phase 3 PULSAR (N=1009; ClinicalTrials.gov Identifier: NCT04423718) and phase 2/3 PHOTON (N=658; ClinicalTrials.gov Identifier: NCT04429503) trials, which compared the efficacy and safety of aflibercept 8mg to Eylea (aflibercept 2mg) in patients with wAME and DME, respectively. Patients were randomly assigned to receive aflibercept 8mg every 12 weeks or every 16 weeks or aflibercept 2mg every 8 weeks. The primary endpoint for both trials was the change from baseline to week 48 in best corrected visual acuity.
Results from both trials showed that treatment with aflibercept 8mg met the primary endpoint demonstrating noninferior vision gains at week 48 with both the 12- and 16-week dosing regimens after initial monthly doses vs aflibercept 2mg every 8 weeks. The majority of patients treated with aflibercept 8mg were able to maintain the 12- and 16-week dosing regimens through week 48.
In PULSAR, 71% and 67% of wAMD patients treated with aflibercept 8mg 12- and 16-week dosing regimens, respectively, had no retinal fluid in the center subfield compared with 59% of patients who received aflibercept 2mg. The median time to fluid-free subfield was 4 weeks for aflibercept 8mg vs 8 weeks for aflibercept 2mg.
In PHOTON, DME patients treated with aflibercept 8mg 12- and 16-week dosing regimens had a mean reduction in the total area of fluorescein leakage from baseline of 14mm2 and 9mm2, respectively, vs 9mm2 for aflibercept 2mg.
Approval of Eylea HD in diabetic retinopathy was based on the PHOTON study.
The EYLEA HDq16 did not meet the non-inferiority criteria for the proportion of patients with a ≥2-step improvement on ETDRS-DRSS and is not considered clinically equivalent to EYLEA administered every 8 weeks.
Results of the subgroups (e.g., age, gender, race, ethnicity, baseline BCVA and prior DME treatment) on the proportion of patients who achieved a ≥2-step improvement on the ETDRS-DRSS from baseline to week 48 were, in general, consistent with those in the overall population.
Eylea Hd Note
Eylea Hd Patient Counseling
In the days following Eylea HD administration, patients are at risk of developing endophthalmitis or retinal detachment. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients to seek immediate care from an ophthalmologist.
Patients may experience temporary visual disturbances after an intravitreal injection with Eylea HD and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.