No black box warning on record for Aflibercept

As of the latest FDA labeling reviewed, Aflibercept (aflibercept) does not carry a black box warning. Standard warnings and precautions still apply — see the full Aflibercept medicine page for the complete safety profile.

Other warnings & precautions

RISK OF ARTERIAL THROMBOEMBOLIC EVENTS: There is a potential risk of arterial thromboembolic events (ATEs), including nonfatal stroke, nonfatal myocardial infarction, and vascular death, following systemic VEGF inhibition. Patients with a history of stroke or myocardial infarction should use aflibercept with caution after discussion of the risk-benefit ratio with their ophthalmologist.
ENDOPHTHALMITIS AND RETINAL DETACHMENT: Intravitreal injections have been associated with endophthalmitis and retinal detachment. Patients should be instructed to report symptoms of endophthalmitis immediately, including eye pain, redness, photophobia, and blurred vision.
INCREASE IN INTRAOCULAR PRESSURE: Acute increases in intraocular pressure (IOP) have been observed within 60 minutes of intravitreal injection. IOP and optic nerve perfusion should be monitored and managed appropriately post-injection.
HYPERSENSITIVITY: Hypersensitivity reactions, including anaphylaxis and severe allergic reactions, have been reported. Aflibercept should not be used in patients with known hypersensitivity to aflibercept or any component of the formulation.
USE IN PREGNANCY: Aflibercept may cause fetal harm based on its mechanism of action (VEGF inhibition is essential for normal vascular development). Women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose.
OCULAR SURGERY: Patients scheduled for ocular surgery should inform their surgeon of aflibercept therapy. The drug should be used with caution perioperatively, and injection timing should be coordinated with surgical planning to minimize complication risk.

Other warnings & precautions

RISK OF ARTERIAL THROMBOEMBOLIC EVENTS: There is a potential risk of arterial thromboembolic events (ATEs), including nonfatal stroke, nonfatal myocardial infarction, and vascular death, following systemic VEGF inhibition. Patients with a history of stroke or myocardial infarction should use aflibercept with caution after discussion of the risk-benefit ratio with their ophthalmologist.

ENDOPHTHALMITIS AND RETINAL DETACHMENT: Intravitreal injections have been associated with endophthalmitis and retinal detachment. Patients should be instructed to report symptoms of endophthalmitis immediately, including eye pain, redness, photophobia, and blurred vision.

INCREASE IN INTRAOCULAR PRESSURE: Acute increases in intraocular pressure (IOP) have been observed within 60 minutes of intravitreal injection. IOP and optic nerve perfusion should be monitored and managed appropriately post-injection.

HYPERSENSITIVITY: Hypersensitivity reactions, including anaphylaxis and severe allergic reactions, have been reported. Aflibercept should not be used in patients with known hypersensitivity to aflibercept or any component of the formulation.

USE IN PREGNANCY: Aflibercept may cause fetal harm based on its mechanism of action (VEGF inhibition is essential for normal vascular development). Women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose.

OCULAR SURGERY: Patients scheduled for ocular surgery should inform their surgeon of aflibercept therapy. The drug should be used with caution perioperatively, and injection timing should be coordinated with surgical planning to minimize complication risk.

Aflibercept Black Box Warning

No black box warning on record for Aflibercept

Other warnings & precautions

Aflibercept Black Box Warning

No black box warning on record for Aflibercept

Other warnings & precautions