aflibercept

aflibercept

Eylea

Pharmacologic class: Vascular endothelial growth factor (VEGF) inhibitor

Therapeutic class: Ophthalmic agent

Pregnancy risk category C

Action

VEGF-A and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability. 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.

Availability

Solution for ophthalmic injection: 40 mg/ml in 3-ml (0.278-ml fill) single-use vials

Indications and dosages

Neovascular (wet) age-related macular degeneration

Adults: 2 mg (0.05 ml) by intravitreal injection into affected eye q 4 weeks for the first 3 months, followed by 2 mg (0.05 ml) once q 8 weeks

Contraindications

• Hypersensitivity to drug or its components

• Ocular or periocular infection

• Active intraocular inflammation

Precautions

Use cautiously in:

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Be aware that drug should be administered by ophthalmic intravitreal injection only under controlled aseptic conditions by a qualified health care professional.

• Provide adequate anesthesia and a topical broad-spectrum anti-infective before the injection, as prescribed.

• Inspect drug for particulate matter and discoloration before administering.

• Use a filter needle to draw up the prescribed dose; remove the filter needle from syringe, and attach a 30G, ½-inch injection needle for the intravitreal injection. Discard unused drug after injection.

• Be aware that each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, use a new vial and change all equipment.

• Immediately following the intravitreal injection, assess patient for increased intraocular pressure (IOC).

Adverse reactions

CNS: nonfatal stroke

CV: nonfatal MI, vascular death

EENT: conjunctival hyperemia, conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, increased IOC, endophthalmitis, corneal erosion, corneal edema, retinal detachment, retinal tear, retinal pigment epithelium tear, injection-site pain, injection-site hemorrhage, foreign body sensation in eye, increased lacrimation, blurred vision, eyelid edema

Other: hypersensitivity

Interactions

None

Patient monitoring

• Continue to monitor patient for increased IOP, endophthalmitis, retinal detachment, and arterial thromboembolic events and be prepared to treat appropriately.

Patient teaching

Instruct patient to contact ophthalmologist immediately if treated eye becomes red, light sensitive, or painful, or if vision change occurs.

Instruct patient to immediately report signs and symptoms of stroke (such as weakness on one side of body or slurred speech), chest pain, or other new signs and symptoms.

• Caution patient to avoid driving and other hazardous activities until visual function has recovered sufficiently.

• As appropriate, review all other significant and life-threatening adverse reactions mentioned above.

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References in periodicals archive ?
Contract award notice: Supply of eylea medications (aflibercept 4 mg injectable 100 microliters) to the pharmacy service of the san carlos clinic hospital in madrid (spain-madrid: Pharmaceutical products)
The second phase, enrolling up to 90 patients, is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose AR-13503 SR Implant, dosed as monotherapy and in combination with aflibercept, compared to aflibercept alone.
Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe.
The US Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe to treat neovascular (wet) age-related macular degeneration (Wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).
* Injection of aflibercept, an anti-vascular endothelial growth factor (anti-VEGF) medication that blocks the development of new blood vessels and limits leakage from the abnormal blood vessels in the eye.
The research found that there was no significant difference in the proportion of patients who experienced a five-letter decrease in visual acuity at two years between those managed through aflibercept, laser photocoagulation and observation.
Food and Drug Administration (FDA) has approved EYLEA[R] (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness.
The treatment options include Bevacizumab, Ranibizumab and Aflibercept. A study conducted by Campochiaro et al demonstrated comparison of Ranibizumab and Bevacizumab on visual acuity and CRT in patients with BRVO11,12.
(1,2,3,4,5,6,7) The first labeled intravitreal drug for the treatment of nAMD was pegaptanib, then off-label drug bevacizumab and approved drugs aflibercept and ranibizumab have led us to prevention of vision loss in most of the nAMD patients and vision gain in one third of them.
For HS analysis, the patients were divided into three groups: patients with eyes with AMD naive to treatment and AMD patients who had already received 1-2 and 3-5 injections of aflibercept (Eylea, Bayer AG, Leverkusen, Germany).
The patient was treated with an intravitreal injection of aflibercept 2 mg (Eylea, Regeneron, Tarrytown, NY) OD.
The VIVIDDME and VISTA-DME studies showed superior visual and anatomical outcomes with intravitreal aflibercept monotherapy compared with laser monotherapy [9-11].