Pavblu (aflibercept-ayyh)

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Aflibercept is administered by intravitreal injection only into the affected eye(s); the drug must be administered only by a qualified physician.

Prior to intravitreal administration, the entire contents of the aflibercept vial should be withdrawn through a sterile 5-mcm, 19-gauge filter needle (provided by the manufacturer) into a 1-mL syringe (provided by the manufacturer) using aseptic technique. The filter needle is then replaced with a sterile 30-gauge, 1/2-inch needle (provided by the manufacturer) for intravitreal injection. To obtain the appropriate aflibercept dose (2 mg), the contents in the syringe should be expelled until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.

Aflibercept should be injected under controlled aseptic conditions (including surgical hand disinfection and use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent)) following adequate anesthesia and administration of a topical broad-spectrum anti-infective agent.

Immediately following intravitreal injection, patients should be monitored for elevation in intraocular pressure (IOP). Monitoring for increased IOP may include evaluation of optic nerve head perfusion or tonometry. A sterile paracentesis needle should be available, if required. Patients should be instructed to immediately report any symptoms suggestive of endophthalmitis or retinal detachment. (See Endophthalmitis and Retinal Detachment under Cautions: Warnings/Precautions.)

Each vial should be used only for the treatment of a single eye; any unused portion must be discarded after administration. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drape, eyelid speculum, and filter and injection needles should be changed before aflibercept is administered into the other eye.

Aflibercept injection should be stored at 2-8degreesC in the original carton; the injection should not be frozen and should be protected from light.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Ocular or periocular infections.

Active intraocular inflammation.

Hypersensitivity (e.g., severe intraocular inflammation) to aflibercept or any ingredient in the formulation.

• Inflammation of orbit
• Ocular infection
• Ocular inflammation

There are no severe contraindications for this drug.

• Arterial thrombosis
• Ocular hypertension

Adverse ocular effects reported in 5% or more of patients receiving aflibercept include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased IOP.

More Frequent

• Cataracts
• Conjunctival hemorrhage
• Vitreous detachment

Less Frequent

• Corneal erosion
• Ocular hypertension
• Retinal pigment epithelial detachment

Rare or Very Rare

• Acute arterial thromboembolism
• Acute myocardial infarction
• Anaphylaxis
• Cerebrovascular accident
• Endophthalmitis
• Retinal detachment
• Retinal hemorrhage
• Retinal tear
• Retinal vasculitis
• Vitreous hemorrhage

More Frequent

• Dry eye
• Ocular pain
• Vitreous floater

Less Frequent

• Blurred vision
• Conjunctival hyperemia
• Corneal edema
• Eye tearing
• Eyelid edema
• Foreign body sensation of eye
• Injection site pain
• Injection site sequelae
• Ocular redness

Rare or Very Rare

• Pruritus of skin
• Scleritis
• Skin rash
• Urticaria

No enhanced messaging available.

Safety and efficacy of aflibercept have not been established in pediatric patients.

Category C. (See Users Guide.)

There are no adequate and well-controlled studies of aflibercept in pregnant women. In embryofetal studies in animals, postimplantation loss and fetal structural malformations were observed when aflibercept was administered parenterally (by IV or subcutaneous injection) to pregnant rabbits at doses producing systemic exposures at least 10 times higher than those achieved with the recommended intravitreal dose in humans. Aflibercept should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Women of childbearing potential should use effective contraception prior to initiation of therapy, during treatment, and for at least 3 months after the last intravitreal injection of aflibercept is administered.

It is not known whether aflibercept is distributed into human milk. Use of aflibercept is not recommended in nursing women. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

In clinical studies, approximately 76% of patients randomized to receive aflibercept were 65 years of age or older, and approximately 46% were 75 years of age or older. No substantial differences in safety or efficacy were observed between geriatric and younger adults.