Enzeevu

Enzeevu (aflibercept-abzv) is a prescription eye preparation used to treat retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), diabetic retinopathy (DR), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

Enzeevu is given as an intravitreal injection usually every four weeks initially, then the dose schedule may change depending on the condition being treated and the pateints response to treatment.

Enzeevu is a biosimilar of Eylea (aflibercept). A biosimilar means that Enzeevu is approved to be highly similar to Eylea (the reference product) and that there are no clinically meaningful differences between them when it is used for the FDA-approved indication, dosing regimens, strength(s), dosage form(s), and route(s) of administration.

Enzeevu is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

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

You should not use Enzeevu if you are allergic to aflibercept, Eylea, Eylea HD, or any other biosimilar or any of the inactive ingredients in these preparations.

Get emergency medical help if you have any signs of an allergic reaction to Enzeevu such as hives, difficulty breathing, or swelling of your eyes, face, lips, tongue, or throat.

Do not receive an Enzeevu injection 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; or
• sudden severe headache, confusion, problems with speech or balance.

There is a risk of endophthalmitis (a serious inflammation of the intraocular fluids, usually due to infection), and retinal detachments may occur following intravitreal injections. 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 Enzeevu, or the associated eye examinations. Do not drive or operate machinery until your vision recovers.

Thromboembolic events There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

You should not receive Enzeevu 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
• 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

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant while using Enzeevu. 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 Enzeevu injection.

Breastfeeding

Do not breastfeed while you are using Enzeevu.

The most common Enzeevu side effects are eye pain, cataracts, vitreous detachment, conjunctival bleeding, vitreous floaters, and increased intraocular pressure. These side effects occurred in 5% or more of patients.

Also, see the Warnings section for more serious side effects.

Recommended dose for Neovascular (Wet) Age-Related Macular Degeneration (AMD)

Initial dose: 2 mg (0.05 mL of 40 mg/mL solution) given by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months.

Maintenance dose: 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months). (2.2)

Other dosage regimes for neovascular (wet) age-related macular degeneration Enzeevu may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).

Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.

Recommended dose Macular Edema Following Retinal Vein Occlusion (RVO)

Dose: 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly)

Recommended Enzeevu dose for Diabetic Macular Edema (DME)

Initial doses: 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections,

Maintenance dose: 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although Enzeevu may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months).

Recommended Enzeevu dose for Diabetic Retinopathy (DR)

Initial doses: 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections.

Maintenance doses: 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months). Although Enzeevu may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks(monthly) dosing after the first 20 weeks (5 months).

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

An overdose is unlikely because Enzeevu are administered by healthcare professionals. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

It is not likely that other drugs you take orally or inject will have an effect on Enzeevu 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.

• Store 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. Do not open sealed blister tray or vial until time of use.
• Prior to usage, the unopened blister or vial of Enzeevu may be stored at room temperature (below 30°C/86°F) for up to 14 days.

Manufactured by: Sandoz Inc. Princeton, NJ 08540

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Enzeevu.

Eylea (aflibercept) - Regeneron Pharmaceuticals, Inc.

View Eylea information in detail.

Eylea HD (aflibercept) - Regeneron Pharmaceuticals, Inc.

View Eylea HD information in detail.

Eylea interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Yesafili (aflibercept-jbvf) - Biocon Biologics Inc.

View Yesafili information in detail.

Eylea biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Ahzantive (aflibercept-mrbb) - Formycon AG

View Ahzantive information in detail.

Pavblu (aflibercept-ayyh) - Amgen Inc.

View Pavblu information in detail.

Yesafili (aflibercept-jbvf) - Biocon Biologics Inc.

View Yesafili information in detail.