Enzeevu
Generic name: aflibercept-abzv
Dosage form: prefilled syringe 2 mg (0.05 mL of 40 mg/mL), vial 2 mg (0.05 mL of 40 mg/mL)
Drug class: Anti-angiogenic ophthalmic agents
What is Enzeevu?
Enzeevu is an injectable eye preparation used to treat neovascular (wet) age-related macular degeneration (AMD); it 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 (aflibercept-abzv) can be given as an intravitreal injection every four weeks for the first three months and then once every eight weeks (2 months), although there are different dosage regimes.
Enzeevu Side Effects
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.
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Warnings
You should not use Enzeevu if you are allergic to aflibercept, Eylea, Eylea HD, 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 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.
Before using Enzeevu
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.
How is Enzeevu given?
Enzeevu are 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.
Enzeevu Dosing Information
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
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.
What happens if I miss a dose?
Call your doctor to reschedule if you miss an appointment for your Enzeevu injection.
What happens if I overdose?
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.
What should I avoid?
Enzeevu 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 Enzeevu?
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.
Storage
- 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.
Company
Manufactured by: Sandoz Inc. Princeton, NJ 08540
Enzeevu Biosimilars
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.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 2 mg/0.05 mL |
Single-Dose Vial | 2 mg/0.05 mL |
View Eylea information in detail.
Eylea HD (aflibercept) - Regeneron Pharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 8 mg/0.07 mL |
View Eylea HD 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
Formulation type | Strength |
---|---|
Single-Dose Vial | 2 mg/0.05 mL |
View Ahzantive information in detail.
Pavblu (aflibercept-ayyh) - Amgen Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 2 mg/0.05 mL |
Single-Dose Vial | 2 mg/0.05 mL |
View Pavblu information in detail.
Popular FAQ
Does Eylea have a biosimilar?
Yes, Eylea has five biosimilars: two that are designated as interchangeable (Opuviz and Yesafili) and three that are not interchangeable (Ahzantive, Enzeevu and Pavblu). An interchangeable biosimilar is a biologic product that can usually be substituted for the reference product (in this case, Eylea) by your pharmacist without approval from your doctor. Continue reading
What’s the difference between Eylea, Eylea HD, and Avastin?
Eylea, Eylea HD, and Avastin may all be used to treat neovascular (wet) age-related macular degeneration (AMD), as injections into the eye (intravitreal injections). Both Eylea and Eylea HD are FDA-approved for this indication, but use of Avastin is off-label (not an FDA-approved indication - although it has been used for this purpose since 2005). Eylea HD is a longer acting version of Eylea. Continue reading
What is the difference between Eylea and Eylea HD?
Eylea HD is a higher dose, longer-acting formulation of Eylea that has been approved to treat Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Eylea is approved to treat these conditions in addition to Macular Edema Following Retinal Vein Occlusion (RVO) and Retinopathy of Prematurity (ROP). Continue reading
Does Eylea and Eylea HD raise blood pressure?
Eylea and Eylea HD injections into the eye (intravitreal) are associated with a substantial but temporary increase in blood pressure in some patients. Increases in intraocular pressure (the pressure inside the eye) have also been seen within 60 minutes of an injection of Eylea or Eylea HD. Continue reading
More FAQ
References
More about Enzeevu (aflibercept ophthalmic)
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: anti-angiogenic ophthalmic agents
- Breastfeeding
Patient resources
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.