Aflibercept (Ophthalmic)

Name: Aflibercept (Ophthalmic)

What Is Aflibercept ophthalmic?

Aflibercept is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with a certain type of eye disease, new blood vessels grow under the retina where they leak blood and fluid. This is known as the "wet form" of macular degeneration.

Aflibercept ophthalmic (for the eyes) is used to treat wet age-related macular degeneration. Aflibercept is also used to treat swelling in the retina caused by a blockage in the blood vessels.

Aflibercept ophthalmic is also used to treat diabetic retinopathy, an eye disorder in diabetics that can lead to a buildup of fluid in the retina and cause blindness.

Aflibercept ophthalmic may also be used for purposes not listed in this medication guide.

You should not use aflibercept if you have swelling inside your eyes, or any type of infection in or around your eyes.

Call your doctor at once if you have eye pain or redness, swelling or puffiness around your eyes, or sudden vision problems at any time during treatment.

You should not use aflibercept if you are allergic to it, or if you have:

  • swelling inside your eyes; or
  • any type of infection (bacterial, fungal, viral) in or around your eyes.

To make sure aflibercept is safe for you, tell your doctor if you have:

  • history of blood clot or stroke; or
  • glaucoma or other condition that increase pressure inside your eyes.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy before your first dose of this medicine. Keep using birth control for at least 3 months after your last injection.

It is not known whether aflibercept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Aflibercept ophthalmic Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • eye pain or redness, swelling around your eyes;
  • sudden vision problems;
  • seeing flashes of light or "floaters" in your vision, seeing halos around lights;
  • increased sensitivity of your eyes to light;
  • sudden numbness or weakness, especially on one side of the body; or
  • sudden severe headache, confusion, problems with speech or balance.

Common side effects may include:

  • red or watery eyes;
  • blurred vision;
  • swelling of the eyelids; or
  • mild eye pain or discomfort after the injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses of Aflibercept

  • It is used to treat macular degeneration.
  • It is used to treat macular swelling.
  • It is used to treat some eye problems caused by diabetes.

Dosing Geriatric

Refer to adult dosing.

Reconstitution

Each vial should only be used for the treatment of 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 aflibercept is administered to the other eye. Inspect vial prior to administration; do not use if particulates, cloudiness, or discoloration are present.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Store in original container prior to use. Discard unused product.

Adverse Reactions

>10%: Ophthalmic: Conjunctival hemorrhage (12% to 31%), cataract (5% to 19%), eye pain (9% to 13%)

1% to 10%:

Cardiovascular: Arterial thrombosis (2% to 6%)

Central nervous system: Foreign body sensation of eye (3%)

Immunologic: Antibody development (1% to 3%; most patients had immunoreactivity at baseline)

Local: Pain at injection site (1% to 3%), bleeding at injection site (≤1%)

Ophthalmic: Increased intraocular pressure (2% to 9%), vitreous detachment (2% to 8%), vitreous opacity (1% to 8%), epithelial keratopathy (2% to 7%), ocular hyperemia (4% to 5%), increased lacrimation (3% to 4%), retinal pigment epithelium detachment (3%), intraocular inflammation (2% to 3%), retinal pigment epithelium tear (2%), blurred vision (1% to 2%), eyelid edema (1% to 2%), corneal edema (≤1%)

<1% (Limited to important or life-threatening): Endophthalmitis, hypersensitivity, retinal detachment, uveitis

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Women of reproductive potential should use effective contraception prior to initial dose, during treatment, and for at least 3 months after the last intravitreal injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect aflibercept ophthalmic?

It is not likely that other drugs you take orally or inject will have an effect on aflibercept used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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