INDICATIONS

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).

PAVBLU™ (aflibercept-ayyh) is indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration ...Read more

Indications Prescribing Information AmgenSupportPlus.com AmgenBiosimilars.com
Chapter 1: Trial Design
Chapter 2: Efficacy
Chapter 3: Safety
Chapter 4: Dosing and Administration
Chapter 5: Amgen SupportPlus
Chapter 6: Q and A

RESOURCES TO HELP SUPPORT PATIENTS

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INTEGRATED PORTAL FOR PAVBLU™ ACCESS SUPPORT

We created a 2-way communication flow between our Amgen® SupportPlus Customer Portal and commonly used platforms that can give you real-time access to information and resources.

When you prescribe PAVBLU™, you can USE AN INTEGRATED PORTAL PLATFORM TO:

Benefits verification formBenefits verification form

Submit a Benefits Verification Form

Patient summary of benefitsPatient summary of benefits

View Your Patients’ Summary of Benefits

Assist with co-pay program enrollmentAssist with co-pay program enrollment

Assist Your Patients With Co-Pay Program Enrollment

Access co-pay program statusAccess co-pay program status

Access Your Patients’ Co-Pay Program Status And Information

Visit the Amgen® SupportPlus Customer Portal, or an integrated portal platform

HCP SUPPORT CENTER
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HCP SUPPORT CENTER

Our Amgen® SupportPlus representatives can assist with issues around patient coverage, prior authorizations, Amgen® SupportPlus Co-Pay Program, and more.

Benefits verification
  • Verify patient's insurance plan coverage details
Prior authorization requirements
  • Provide payer-specific prior authorization forms
Amgen® SupportPlus customer portal
  • A tool for managing patient benefits verification and more
  • Submit, store, and retrieve benefit verifications electronically
  • Integration with commonly used platforms for real-time status regardless of platform

Field Reimbursement SPECIALISTS

A Field Reimbursement Specialist can provide live or virtual coverage and access resources to support your patients that include:

  • Help with navigating prior authorization, appeals, and fulfillment processes
  • Educating on payer requirements and necessary documentation for individual patient support
  • Guidance on general reimbursement questions, including product coding and billing information
  • Answers to general questions about Amgen® SupportPlus programs and other available resources

AMGEN® SUPPORTPLUS CO-PAY PROGRAM

Amgen® SupportPlus Example Co-pay Card

AMGEN® SUPPORTPLUS CO-PAY PROGRAM

The Amgen® SupportPlus Co-Pay Program may help eligible patients with private or commercial insurance lower their out-of-pocket costs.

  • Eligible patients may pay as little as $0 out-of-pocket for each dose and receive up to $1,000 per calendar year for in-office administration out-of-pocket costs*
  • No income eligibility requirement

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay-terms for full Terms and Conditions. Massachusetts and Rhode Island residents not eligible for in-office administration support.

Encourage your patients with private or commercial insurance to check eligibility and enroll at AmgenSupportPlus.com/copay

Visit AmgenSupportPlus.com or call 866-264-2778 Monday to Friday, 9:00 AM to 8:00 PM ET.

Important Safety Information

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.

Please see the full Prescribing Information for additional Important Safety Information.

INDICATIONS

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) 
  • Diabetic Retinopathy (DR)

Important Safety Information

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™.

PAVBLU™ is a trademark of Amgen, Inc.