XII Congreso Internacional - Ushuaia, Tierra del Fuego

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  • Dear Health Care Provider:

    The purpose of this letter is to notify you of an update to the Dosage and Administration section of the EYLEA® (aflibercept) Injection U.S. Prescribing Information (USPI) to clarify dosing for patients with Neovascular (wet) Age-Related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME.

    The revised wAMD Dosage and Administration guidance from the USPI is below. The new clarifying language is underlined:
    The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 12 weeks (3 months).

    The revised DME and DR in patients with DME Dosage and Administration guidance from the USPI is below. The new clarifying language is underlined:
    The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months).

    Prescriber Action
    The label language clarification recognizes that while most patients receiving EYLEA will require dosing once every 8 weeks (2 months) after the initial monthly dosing period, some patients may still require monthly dosing. This label clarification provides clearer direction on the approved dosing option of an every 4-week interval that has been described in the US Prescribing Information since the initial approval of EYLEA in 2011. Please continue to consider the most appropriate dosing for your patients when prescribing EYLEA.

    Reporting Adverse Events
    Health care providers and patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    If you have any questions about the information contained in this letter or the safe and effective use of EYLEA, you may contact the Regeneron Medical Information department at 1-855-395-3248 or visit www.EYLEA.com

    This letter is not intended as a complete description of the benefits and risks related to the use of EYLEA. Please refer to the full prescribing information.

    Sincerely,

    Namrata Saroj, OD
    Sr. Medical Director
    Ophthalmology Medical Affairs
    Regeneron Pharmaceuticals, Inc

    IMPORTANT SAFETY INFORMATION FOR EYLEA (aflibercept) INJECTION

    • EYLEA (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
    • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
    • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. 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 EYLEA. 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 EYLEA. 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 EYLEA 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 EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.
    • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
    • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.

    IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION
    EYLEA® (aflibercept) Injection is indicated for the treatment of patients with

    • Neovascular (Wet) Age-related Macular Degeneration (AMD): The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).
    • Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly).
    • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with DME: The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections, followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).

    Please see EYLEA® (aflibercept) Injection Full Prescribing Information

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