aflibercept

REMS

Ahzantive, Enzeevu, Eyelea, Eyelea HD, Opuviz, Pavblu, and Yesafili

Neovascular (wet) age-related macular degeneration (AMD).

Ahzantive, Eyelea, Eyelea HD, Opuviz, Pavblu, and Yesafili

Treatment of the following conditions:
- Diabetic macular edema,
- Diabetic retinopathy.

Ahzantive, Eyelea, Opuviz, Pavblu, and Yesafili

Macular edema following central retinal vein occlusion.

Eyelea

Retinopathy of prematurity.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Ocular/periocular infection;Active intraocular inflammation;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
OB: Use during pregnancy only if potential maternal benefit justifies fetal risk;
Pedi: Safety and effectiveness only established in preterm infants with retinopathy of prematurity. Safety and effectiveness not established in children <18 yr for all other indications.

Adv. Reactions/Side Effects ⬆ ⬇

CV: MI

EENT: conjunctival hemorrhage, eye pain, blurred vision, cataract, corneal edema, corneal erosion, conjunctival hyperemia, detachment of retinal pigment epithelium, endophthalmitis (from procedure), eyelid edema, foreign body sensation, injection site hemorrhage/pain, intraocular inflammation, ↑intraocular pressure, ↑lacrimation, retinal detachment (from procedure), retinal vasculitis (with or without occlusion), vitreous detachment, vitreous floaters

Neuro: STROKE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for injection (vials and prefilled syringes) (Enzeevu, Eyelea, and Pavblu): 2 mg/0.05 mL
Solution for injection (vials) (Ahzantive, Opuviz and Yesafili): 2 mg/0.05 mL
Solution for injection (vials) (Eyelea HD): 8 mg/0.07 mL

Route/Dosage ⬆ ⬇

Neovascular (Wet) AMD

Intravitreal (Adults ): Ahzantive, Enzeevu, Eyelea, Opuviz, Pavblu, and Yesafili: 2 mg every 4 wk for first 3 doses; then 2 mg every 8 wk (some patients may continue to require every 4 wk dosing). After one yr of therapy, may consider dosing every 12 wk. Eyelea HD: 8 mg every 4 wk for first 3 doses; then 8 mg every 8–16 wk.

Macular Edema Following Central Retinal Vein Occlusion

Intravitreal (Adults ): Ahzantive, Eyelea, Opuviz, Pavblu, and Yesafili: 2 mg every 4 wk.

Diabetic Macular Edema

Intravitreal (Adults ): Ahzantive, Eyelea, Opuviz, Pavblu, and Yesafili: 2 mg every 4 wk for first 5 injections; then 2 mg every 8 wk (some patients may continue to require every 4 wk dosing). Eyelea HD: 8 mg every 4 wk for first 3 doses; then 8 mg every 8–16 wk.

Diabetic Retinopathy

Intravitreal (Adults ): Ahzantive, Eyelea, Opuviz, Pavblu, and Yesafili: 2 mg every 4 wk for first 5 injections; then 2 mg every 8 wk (some patients may continue to require every 4 wk dosing). Eyelea HD: 8 mg every 4 wk for first 3 doses; then 8 mg every 8–12 wk.

Retinopathy of Prematurity

Intravitreal (Children [Preterm Infants]): Eyelea:0.4 mg in affected eye(s). Dose may be repeated after 10 days, if needed.

US Brand Names ⬆ ⬇

Ahzantive, Enzeevu, Eylea, Eylea HD, Opuviz, Pavblu, Yesafili

Action ⬆ ⬇

Binds to and inactivates vascular endothelial growth factor (VEGF) receptors, which normally promote neovascularization and vascular permeability.

Therapeutic effects:

Slowed progression of AMD.
Decreased macular edema following central retinal vein occlusion.
Improved visual acuity in diabetic macular edema.
Decreased severity of diabetic retinopathy.
Absence of both active retinopathy of prematurity and unfavorable structural outcomes.

Classifications ⬆ ⬇

Therapeutic Classification: ocular agents

Pharmacologic Classification: vascular endothelial growth factor antagonists

Pharmacokinetics ⬆ ⬇

Absorption: Action is local following intravitreal injection; minimal systemic absorption occurs.

Distribution: Distribution occurs mainly in the vitreal space.

Metabolism/Excretion: Used up in the binding process and degraded by proteolytic enzymes.

Half-Life: 5–6 days (plasma).

Time/Action Profile ⬆ ⬇

(improved visual acuity)

ROUTE	ONSET	PEAK	DURATION
intravitreal	rapid (within 4 wk)	8–12 wk	maintained throughout treatment

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of aflibercept to patient. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Medication Guidebefore starting and periodically during therapy in case of changes.
Advise patient to notify health care professional immediately if signs and symptoms of endophthalmitis or retinal detachment (eye pain, redness of eye, sensitivity to light, blurry vision, flashing lights or shadows in vision) or hypersensitivity reactions (anaphylaxis, rash, pruritus, urticaria, severe intraocular inflammation) occur.
May cause visual disturbances. Caution patient not to drive until visual function has sufficiently recovered.
Rep: Advise females of reproductive potential to use effective contraception prior to initial dose, during treatment, and for ≥3 mo (Eylea) or 4 mo (Eylea HD) following completion of therapy and to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇