Generic Name
Aflibercept
Brand Names
Pavblu, Eylea, EYDENZELT boav, Zaltrap
FDA approval date: November 21, 2011
Classification: Vascular Endothelial Growth Factor Inhibitor
Form: Injection, Solution
What is Pavblu (Aflibercept)?
EYDENZELT is indicated for the treatment of: EYDENZELT is a vascular endothelial growth factor inhibitor indicated for the treatment of patients with: Neovascular Age-Related Macular Degeneration .
Approved To Treat
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Brand Information
PAVBLU (aflibercept-ayyh)
1INDICATIONS AND USAGE
PAVBLU is indicated for the treatment of:
2DOSAGE FORMS AND STRENGTHS
PAVBLU is a clear to opalescent and colorless to slightly yellow solution available as:
- Injection: 2 mg (0.05 mL of 40 mg/mL solution) in a single-dose prefilled plastic syringe
- Injection: 2 mg (0.05 mL of 40 mg/mL solution) in a single-dose glass vial
3ADVERSE REACTIONS
The following potentially serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity
- Endophthalmitis, retinal detachments, and Retinal Vasculitis with or without Occlusion
- Increase in intraocular pressure
- Thromboembolic events
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice.
A total of 2980 adult patients treated with aflibercept constituted the safety population in eight phase 3 studies. Among those, 2379 patients were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with aflibercept including endophthalmitis and retinal detachment. The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of aflibercept. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye disorders: retinal vasculitis and occlusive retinal vasculitis related to intravitreal injection with aflibercept (reported at a rate of 0.6 and 0.2 per 1 million injections, respectively, based on postmarketing experience from November 2011 until November 2023).
4OVERDOSAGE
Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdosage, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
5DESCRIPTION
Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells.
PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2.
6PATIENT COUNSELING INFORMATION
In the days following PAVBLU administration, patients are at risk of developing endophthalmitis, retinal detachment, or retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients and/or caregivers to seek immediate care from an ophthalmologist
Patients may experience temporary visual disturbances after an intravitreal injection with PAVBLU and the associated eye examinations
7PRINCIPAL DISPLAY PANEL - 0.05 mL Syringe Carton
2 mg /
AMGEN
PAVBLU™
NDC 55513-056-01
2 mg (0.05 mL of 40 mg/mL solution)
Carton contents: one blister pack containing one sterile, single-dose prefilled plastic
Prefilled syringe contents:
Recommended Dosage: See prescribing information.
Rx Only
8PRINCIPAL DISPLAY PANEL - 0.05 mL Vial Carton
2 mg /
NDC 55513-065-01
PAVBLU™
2 mg (0.05 mL of
For Intravitreal Injection
Sterile Solution
AMGEN
