Eylea Hd

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  • Miscellaneous ocular agents
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Eylea Hd Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Aflibercept 8mg/0.07mL; soln for oph intravitreal inj; preservative-free.

    Pharmacological Class

    Recombinant fusion protein (human VEGF inhibitor + human IgG1).

    See Also

    How Supplied

    Kit (Eylea, Eylea HD)—1 (single-use vial w. supplies); Single-use prefilled syringe (Eylea)—1; Single-use vial (Eylea HD)—1

    How Supplied

    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.

    Storage

    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. 

    Manufacturer

    Regeneron

    Generic Availability

    NO

    Mechanism of Action

    Aflibercept acts as a soluble decoy receptor that binds VEGF-A and PlGF, and thereby can inhibit the binding and activation of these cognate VEGF receptors.

    Eylea Hd Indications

    Indications

    Neovascular (wet) age-related macular degeneration (AMD). Diabetic macular edema (DME). Diabetic retinopathy (DR). 

    Eylea Hd Dosage and Administration

    Adult

    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).

    Children

    Not established.

    Administration

    Using aseptic technique the intravitreal injection should be performed with a 30-gauge x ½-inch injection needle. Each vial should only be used to treat a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before administered to the other eye. Discard unused product.

    Nursing Considerations

    Using aseptic technique the intravitreal injection should be performed with a 30-gauge x ½-inch injection needle. Each vial should only be used to treat a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before administered to the other eye. Discard unused product. Advise patients to seek immediate care if eye becomes red, sensitive to light, painful, or a change in vision develops.

    Eylea Hd Contraindications

    Contraindications

    Ocular or periocular infections. Active intraocular inflammation.

    Eylea Hd Boxed Warnings

    Not Applicable

    Eylea Hd Warnings/Precautions

    Warnings/Precautions

    Must only be administered by a qualified physician. Evaluate if endophthalmitis, retinal detachment, or retinal vascultis with or without occlusion 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.

    Warnings/Precautions

    Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion

    • Must always use proper aseptic injection technique during administration. Instruct patients to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis 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.

    Thromboembolic Events  

    • 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.

    Pregnancy Considerations

    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.

    Pediatric Considerations

    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

    Absorption

    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.

    Distribution

    The volume of distribution of free aflibercept following intravenous administration of aflibercept is ~7 L.

    Metabolism

    Aflibercept is a therapeutic protein and no drug metabolism studies have been conducted. Aflibercept is expected to undergo elimination through both target-mediated disposition via binding to free endogenous VEGF and metabolism via proteolysis.

    Elimination

    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

    Not Applicable

    Eylea Hd Adverse Reactions

    Adverse Reactions

    Conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, increased intraocular pressure; hypersensitivity reactions.

    Eylea Hd Clinical Trials

    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

    Not Applicable

    Eylea Hd Patient Counseling

    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.

    Cost Savings Program

    Eylea Patient Support Program

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