Yesafili

Pronunciation: Yes-ah-fill-ee
Generic name: aflibercept
Dosage form: single-dose vial for ophthalmic injection
Drug class: Anti-angiogenic ophthalmic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on May 21, 2024.

What is Yesafili?

Yesafili (aflibercept-jbvf) is an injectable eye preparation that is given by a healthcare provider every one to two months to treat the following conditions:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD) – a condition where new blood vessels grow under the retina where they leak blood and fluid
• Macular Edema Following Retinal Vein Occlusion (RVO) – a swelling in the retina caused by a blockage in the blood vessels
• Diabetic Macular Edema (DME) – a build-up of fluid in the retina that is caused by leaking blood vessels
• Diabetic Retinopathy (DR) – an eye disorder in diabetics that can lead to a buildup of fluid in the retina and cause blindness.

Yesafili is an interchangeable biosimilar to Eylea. A biosimilar is a biological product that is like the reference biologic (in this case Eylea) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. An interchangeable biosimilar is one that can be substituted for the reference product at the pharmacy level, without contacting the prescriber, subject to state laws.

The active ingredient in Yesafili, aflibercept-jbvf, is a vascular endothelial growth factor (VEGF) inhibitor that 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).

Yesafili was FDA-approved on 20 May 2024. Aflibercept was first approved as the brand Eylea on November 18, 2011.

Yesafili side effects

Yesafili can cause serious side effects such as allergic reactions, a serious inflammation of the eye, retinal detachments, eye infections, and an increase in eye pressure, see warnings below.

The most common side effects of Yesafili occurring in 5% or more people were conjunctival hemorrhage (a broken blood vessel in the eye), eye pain, cataracts, vitreous detachment (the separation of the vitreous gel from the retina), vitreous floaters (small dark shapes that float across your vision), and an increase in pressure inside the eye.

Less serious Yesafili 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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Vabysmo, triamcinolone ophthalmic, dexamethasone ophthalmic, Eylea, fluocinolone ophthalmic, Izervay, aflibercept ophthalmic

Warnings

You should not use Yesafili if you are allergic to aflibercept, Eylea, Yesafili, Opuviz, or any of the inactive ingredients in these preparations. Get emergency medical help if you have any signs of an allergic reaction to Yesafili such as hives; difficulty breathing; or swelling of your eyes, face, lips, tongue, or throat.

Do not receive Yesafili if you have swelling or redness inside your eyes, or any type of infection (bacterial, fungal, viral) in or around your eyes.

Call your doctor at once if you have a serious side effect such as:

• eye pain or redness, swelling around your eyes

• sudden vision problems

• seeing flashes of light or "floaters" in your vision, seeing halos around lights

• your eyes may be more sensitive to light

• chest pain

• sudden numbness or weakness, especially on one side of the body

• sudden severe headache, confusion, problems with speech or balance.

There is a possibility that endophthalmitis (a serious inflammation of the intraocular fluids, usually due to infection) and retinal detachments may occur following an intravitreal injection of Yesafili. Call your doctor at once if you have eye pain or redness, swelling or puffiness around your eyes, sensitivity to light, or sudden vision problems at any time during treatment. Arterial thromboembolic events are also possible following intravitreal VEGF inhibitor injections.

Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

Temporary visual disturbances may occur following an intravitreal injection with Yesafili, or the associated eye examinations. Do not drive or operate machinery until your vision recovers.

Before receiving Yesafili

You should not receive Yesafili if you are allergic to aflibercept, Eylea, Yesafili, Opuviz, or any of the inactive ingredients in these preparations, or if you have:

• swelling inside your eyes or

• any type of bacterial, fungal, or viral infection in or around your eyes.

To make sure this medicine is safe for you, tell your doctor if you:

• have had a blood clot or stroke
• have glaucoma or other conditions that increase pressure inside your eyes
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant while using Yesafili. You may need to undertake a pregnancy test if you are a female with childbearing potential. Use effective birth control to prevent pregnancy before your first dose of this medicine. Keep using birth control during treatment and for at least 3 months after your last Yesafili injection.

Breastfeeding

Do not breastfeed while you are using Yesafili.

How is Yesafili administered?

Yesafili is given as an injection into your eye by a healthcare provider who will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or clinic.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Yesafili dosage

The usual recommended dose in adults is 2mg (0.05mL) (one injection) into the affected eye(s).

• Yesafili is usually administered every 4 weeks (approximately every 25 to 28 days, monthly) initially, which may be extended to once every 8 weeks (2 months), depending on the condition.
• In some patients, treatment may be extended to one dose every 12 weeks, although this is not as effective as the recommended every 8-week dosing.
• Follow your doctor's dosing instructions very carefully and keep all your appointments.

What happens if I miss a dose?

Call your doctor to reschedule if you miss an appointment for your Yesafili injection.

What happens if I overdose?

An overdose is unlikely because healthcare professionals administer Yesafili. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you have any concerns.

What should I avoid?

Yesafili may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

What other drugs will affect Yesafili?

It is not likely that other drugs you take orally or inject will have an effect on Yesafili used in the eyes. However, many drugs can interact with each other. Tell your doctor about all the medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Storage

Store Yesafili in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use it beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light.

Yesafili ingredients

Active: aflibercept-jbvf 40 mg/mL

Inactive: histidine (0.047 mg), histidine hydrochloride monohydrate (0.042 mg), polysorbate 20 (0.015 mg), and trehalose (4.5 mg), in water for injection with a pH of 6.2. 

Delivers a dose of 2 mg (0.05 mL) in a single-dose vial. One vial contains more extractable volume than is needed, but only 0.05 mL should be administered into the eye and the rest discarded, otherwise, an overdose may occur. One vial should be used for one eye.

Manufacturer

Biocon Biologics Inc.

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