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| IMPORTANT SAFETY INFORMATION |
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| CONTRAINDICATIONS |
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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™.
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| Please see below for additional Important Safety Information |
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†The NDC has been “zero-filled” to create an 11-digit code that meets HIPAA format standards.
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Click here to download the PAVBLU™ Access Resource Guide
for more access and reimbursement information.
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Coding and coverage policies change periodically and often without warning. The healthcare provider is
solely responsible for determining coverage and reimbursement parameters and appropriate coding for
his/her own patients and procedures. This information is not a guarantee of coverage or reimbursement.
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| IMPORTANT SAFETY INFORMATION (continued) |
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| WARNINGS AND PRECAUTIONS |
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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. |
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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. |
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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). |
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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. |
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| ADVERSE REACTIONS |
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Serious adverse reactions related to the injection procedure have occurred in
<0.1% of intravitreal injections with aflibercept including endophthalmitis and
retinal detachment. |
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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. |
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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. |
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| INDICATIONS |
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PAVBLU™ (aflibercept-ayyh) is indicated for the treatment of Neovascular (Wet)
Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein
Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
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| Please click here for full Prescribing Information for PAVBLUTM. |
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| 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. |
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References: 1. PAVBLUTM (aflibercept-ayyh) prescribing information, Amgen. 2024. 2. EYLEA® (aflibercept) prescribing information, Amgen. 2024.
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EYLEA® is a registered trademark of Regeneron Pharmaceuticals, Inc.
PAVBLU™ is a trademark of Amgen Inc. |
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© 2025 Amgen Inc. All rights reserved. Not for reproduction. USA-938-80040 03/25
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