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

THE SAME DOSING SCHEDULE AS
EYLEA® 2 mg

PAVBLU™ is approved in both single-dose vial and prefilled syringe1

PAVBLU™ OFFERS THE SAME DOSING SCHEDULE AS EYLEA® 2 mg ACROSS INDICATIONS1,2

Indication* Recommended Dosing Schedule PAVBLU™ EYLEA®
Neovascular (wet) Age‑related Macular Degeneration (AMD)† Every 4 weeks for first
3 months, then every
8 weeks thereafter
Diabetic Macular Edema (DME) & Diabetic Retinopathy (DR)‡ Every 4 weeks for first
5 injections, then every
8 weeks thereafter
Macular Edema Following Retinal Vein Occlusion (RVO) Every 4 weeks

*PAVBLU™ is not indicated for Retinopathy of Prematurity, for which Regeneron has marketing exclusivity.1,2

†Although PAVBLU™ may be injected as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was injected every 4 weeks compared to every 8 weeks. Although not as effective as the recommended every-8-week dosing regimen, patients may also be treated with one injection every 12 weeks after one year of effective therapy. Patients should be assessed regularly.1

‡Although PAVBLU™ may be injected as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was injected every 4 weeks compared to every 8 weeks.1

PAVBLU™ is available in both vial and silicone oil-free PFS

PAVBLU™ is approved in both vial and
prefilled plastic syringe that is silicone oil-free1,3

2 mg (0.05 mL of 40 mg/mL solution), intravitreal injection

PAVBLU™ offers a specially designed PFS and storage efficiencies1,3

checkmarkPrefilled plastic syringe that is silicone oil-free
checkmark0.5 mL syringe, with tight dimensional tolerances
checkmarkPrefilled syringe design with backstop function and integrated lock for secure needle connection
checkmarkEfficient packaging design
Consider PAVBLU™ for your patients on their next scheduled dose of aflibercept4

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™.