PAVBLU^® prefilled syringe preparation

CONTRAINDICATIONS

• PAVBLU^® is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known
  hypersensitivity to aflibercept or to any of the excipients in PAVBLU.

WARNINGS AND PRECAUTIONS

• Intravitreal injections, including those with aflibercept products, have been associated with endophthalmitis and retinal
  detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be
  used when administering PAVBLU. Patients and/or caregivers should be instructed to report any signs and/or symptoms
  suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
• Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with aflibercept
  products. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF
  inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
• There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including
  aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of
  unknown cause).
• The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the
  combined group of patients treated with aflibercept compared with 1.5% (9 out of 595) in patients treated with ranibizumab;
  through 96 weeks, the incidence was 3.3% (60 out of 1824) in the aflibercept group compared with 3.2% (19 out of 595) in the
  ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group
  of patients treated with aflibercept compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the
  incidence was 6.4% (37 out of 578) in the combined group of patients treated with aflibercept compared with 4.2% (12 out of
  287) in the control group. There were no reported thromboembolic events in the patients treated with aflibercept in the first six
  months of the RVO studies.

ADVERSE REACTIONS

• 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.
• Patients may experience temporary visual disturbances after an intravitreal injection with PAVBLU and the associated eye
  examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS