Pavblu

Pronunciation: pav-blue
Generic name: aflibercept-ayyh
Dosage form: single-dose vial for ophthalmic injection, single-dose prefilled syringe
Drug class: Anti-angiogenic ophthalmic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 2, 2024.

What is Pavblu?

Pavblu (aflibercept-ayyh) is a biosimilar to Eylea that may be used to treat the following eye conditions: neovascular (Wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

• Pavblu is given as an injection directly into the eye once every 4 to 8 weeks.

Pavblu's mechanism of action involves binding to VEGF-A (vascular endothelial growth factor-A), a substance that encourages the growth of abnormal blood vessels underneath the retina. Pavblu blocks VEGF, reducing VEGF levels and helping to slow the growth of abnormal blood vessels in the eye. This stops fluid leakage, reduces swelling, and prevents further vision loss. In some people, Pavblu may improve vision. Pavblu belongs to the drug class called vascular endothelial growth factor (VEGF) inhibitors.

Pavblu was approved on August 23, 2024, as a biosimilar to Eylea (aflibercept). 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.

Pavblu side effects

The most common side effects of Pavblu are:

• 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)
• increased pressure inside the eye (intraocular pressure).

Call your healthcare provider at once if you experience:

• 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 become 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.

Serious side effects and warnings

Pavblu can cause the following serious side effects.

Allergic reactions. Some people may be allergic to Pavblu. You should not receive it if you are allergic to aflibercept, Pavblu, Ahzantive, Eylea, Enzeevu, Yesafili, Opuviz, or any of the inactive ingredients in the Pavblu preparation. Get emergency medical help if you have any signs of an allergic reaction to Pavblu such as hives, difficulty breathing, or swelling of your eyes, face, lips, tongue, or throat.

Serious eye problems. There is a possibility that 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 (pressure inside the eye) have been seen within 60 minutes of an intravitreal injection.

Risk of blood clots. There is a potential risk of arterial thromboembolic events (blood clots), such as a nonfatal stroke, nonfatal heart attack, or vascular death following the use of VEGF inhibitors such as Pavblu.

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

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.

Before using Pavblu

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

• swelling or redness 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
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

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

There is no data regarding the effects of Pavblu on human fertility.

Breastfeeding

Do not breastfeed while you are using Pavblu.

How is Pavblu administered?

Pavblu 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 another 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.

An Pavblu injection is usually administered every 4 weeks (approximately every 28 days, monthly) initially, and depending on the condition, it may be extended to once every 8 weeks (2 months).

• 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. Other patients may need to continue on the 4 weekly dosing indefinitely.

Follow your healthcare provider's instructions very carefully and keep all your appointments.

Pavblu dosage

The usual recommended dose of Pavblu in adults is2mg (0.05 mL of a 40 mg/mL solution) given by intravitreal injection into each affected eye.

What happens if I miss a dose?

Call your doctor to reschedule if you miss an appointment for your Pavblu injection. The injection can be given as frequently as every 25 days.

What happens if I overdose?

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

What should I avoid?

Pavblu 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 Pavblu?

It is not likely that other drugs you take orally or inject will affect Pavblu. 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

Your healthcare provider will store Pavblu 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.

Ingredients

Pavblu ingredients

Active: aflibercept-ayyh 40 mg/mL.

Inactive polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2.

The single-dose glass vial or prefilled syringe is designed to deliver 0.05 mL (50 microliters) of the solution containing 2 mg of aflibercept-ayyh

Pavblu does not contain an anti-microbial preservative.

Who makes Pavblu?

Amgen, Inc. makes Pavblu.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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