Treat­ment for Di­a­betic Mac­u­lar Edema

Chattanooga Times Free Press - Parade - - Front Page -

Ask your doc­tor, and see PAGE 8 to learn about a treat­ment op­tion.

See how EYLEA may be able to help. On av­er­age, peo­ple with DME gained 10 more let­ters on the eye chart af­ter 1 year on EYLEA in 2 clin­i­cal stud­ies. Visit Dis­cov­erEYLEA.com/Pa­rade or Call 833-EYLEA-TV

IN­DI­CA­TIONS

EYLEA® (afliber­cept) In­jec­tion is a pre­scrip­tion medicine ap­proved for the treat­ment of pa­tients with Wet Agere­lated Mac­u­lar De­gen­er­a­tion (AMD), Mac­u­lar Edema fol­low­ing Reti­nal Vein Oc­clu­sion (RVO), Di­a­betic Mac­u­lar Edema (DME), and Di­a­betic Retinopa­thy (DR) in pa­tients with DME.

IM­POR­TANT SAFETY IN­FOR­MA­TION

EYLEA® (afliber­cept) In­jec­tion is a pre­scrip­tion med­i­ca­tion ad­min­is­tered by in­jec­tion into the eye. You should not use EYLEA if you have an in­fec­tion in or around the eye, eye pain or red­ness, or known al­ler­gies to any of the in­gre­di­ents in EYLEA, in­clud­ing afliber­cept. In­jec­tion into the eye with EYLEA can re­sult in an in­fec­tion in the eye and reti­nal de­tach­ment (sep­a­ra­tion of retina from back of the eye). In­flam­ma­tion in the eye has been re­ported with the use of EYLEA. In some pa­tients, in­jec­tions with EYLEA may cause a tem­po­rary in­crease in eye pres­sure within 1 hour of the in­jec­tion. Sus­tained in­creases in eye pres­sure have been re­ported with re­peated in­jec­tions, and your doc­tor may mon­i­tor this af­ter each in­jec­tion. There is a po­ten­tial risk of se­ri­ous and some­times fa­tal side ef­fects re­lated to blood clots, lead­ing to heart at­tack or stroke in pa­tients re­ceiv­ing EYLEA.

Se­ri­ous side ef­fects re­lated to the in­jec­tion pro­ce­dure with EYLEA are rare but can oc­cur in­clud­ing in­fec­tion in­side the eye and reti­nal de­tach­ment. The most com­mon side ef­fects re­ported in pa­tients re­ceiv­ing EYLEA are in­creased red­ness in the eye, eye pain, cataract, mov­ing spots in the field of vi­sion, in­creased pres­sure in the eye, and vit­re­ous (gel-like sub­stance) de­tach­ment. It is im­por­tant that you con­tact your doc­tor right away if you think you might be ex­pe­ri­enc­ing any side ef­fects, in­clud­ing eye pain or red­ness, light sen­si­tiv­ity, or blur­ring of vi­sion, af­ter an in­jec­tion. EYLEA is for pre­scrip­tion use only. For ad­di­tional safety in­for­ma­tion, please talk to your doc­tor and see the full Pre­scrib­ing In­for­ma­tion for EYLEA. 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 Con­sumer Brief Sum­mary on the ad­ja­cent pages. EYLEA is a reg­is­tered trade­mark of Re­gen­eron Phar­ma­ceu­ti­cals, Inc.

Con­sumer Brief Sum­mary This sum­mary con­tains risk and safety in­for­ma­tion for pa­tients about EYLEA. It does not in­clude all the in­for­ma­tion about EYLEA and does not take the place of talk­ing to your eye doc­tor about your med­i­cal con­di­tion or treat­ment. What is EYLEA? EYLEA is a pre­scrip­tion medicine that works by block­ing vas­cu­lar en­dothe­lial growth fac­tor (VEGF). VEGF can cause fluid to leak into the mac­ula (the light-sen­si­tive tis­sue at the back of the eye re­spon­si­ble for sharp cen­tral vi­sion). Block­ing VEGF helps re­duce fluid from leak­ing into the mac­ula. What is EYLEA used for? EYLEA is in­di­cated for the treat­ment of pa­tients with: • Neo­vas­cu­lar (Wet) Age-Re­lated Mac­u­lar De­gen­er­a­tion (AMD) • Mac­u­lar Edema Fol­low­ing Reti­nal Vein Oc­clu­sion (RVO) • Di­a­betic Mac­u­lar Edema (DME) • Di­a­betic Retinopa­thy (DR) in Pa­tients with DME How is EYLEA given? EYLEA is an in­jec­tion ad­min­is­tered by your eye doc­tor into the eye. De­pend­ing on your con­di­tion, EYLEA in­jec­tions are given on dif­fer­ent sched­ules. Con­sult with your eye doc­tor to con­firm which EYLEA sched­ule is ap­pro­pri­ate for you. Who should not use EYLEA? Do not use EYLEA if you have an in­fec­tion in or around the eye, eye pain or red­ness, in­flam­ma­tion in the eye, or are al­ler­gic to afliber­cept and/or any other in­gre­di­ents in EYLEA. What is the most im­por­tant in­for­ma­tion I should know about EYLEA? • EYLEA must only be ad­min­is­tered by a qual­i­fied eye doc­tor. In­jec­tion into the eye with EYLEA can re­sult in an in­fec­tion in the eye and reti­nal de­tach­ment (sep­a­ra­tion of retina from back of the eye). In­flam­ma­tion in the eye has been re­ported with the use of EYLEA. If your eye be­comes red, sen­si­tive to light, painful, or de­vel­ops a change in vi­sion, seek im­me­di­ate care from an eye doc­tor • In­jec­tions with EYLEA may cause a tem­po­rary in­crease in eye pres­sure within 1 hour of the in­jec­tion. Sus­tained in­creases in eye pres­sure have been re­ported with re­peated in­jec­tions, and your eye doc­tor may mon­i­tor this af­ter each in­jec­tion • There is a po­ten­tial risk of se­ri­ous and some­times fa­tal side ef­fects re­lated to blood clots, lead­ing to heart at­tack or stroke in pa­tients re­ceiv­ing EYLEA • You may ex­pe­ri­ence tem­po­rary vis­ual prob­lems af­ter re­ceiv­ing EYLEA and also dur­ing and/or af­ter the eye doc­tor vis­its that will fol­low. Avoid driv­ing or us­ing ma­chin­ery un­til your sight has re­cov­ered • Be­cause EYLEA is com­posed of large mol­e­cules, your body may re­act to it; there­fore, there is a po­ten­tial for an im­mune re­sponse (al­lergy-like) in pa­tients treated with EYLEA

What are pos­si­ble side ef­fects of EYLEA? EYLEA can cause se­ri­ous side ef­fects, in­clud­ing • See side ef­fects listed un­der “What is the most im­por­tant in­for­ma­tion I should know about EYLEA?” The most com­mon side ef­fects in­clude • In­creased red­ness in the eye • Eye pain • Cataract • Mov­ing spots in the field of vi­sion • In­creased pres­sure in the eye • Vit­re­ous (gel-like sub­stance) de­tach­ment There are other pos­si­ble side ef­fects of EYLEA. For more in­for­ma­tion, ask your eye doc­tor. It is im­por­tant that you con­tact your doc­tor right away if you think you might be ex­pe­ri­enc­ing any side ef­fects, in­clud­ing eye pain or red­ness, light sen­si­tiv­ity, or blur­ring of vi­sion, af­ter an in­jec­tion. 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. What should I tell my eye doc­tor be­fore re­ceiv­ing EYLEA? • Tell your eye doc­tor if you have any med­i­cal con­di­tions • Tell your eye doc­tor if you are preg­nant or are plan­ning to be­come preg­nant. It is not known if EYLEA may harm your un­born baby • Tell your eye doc­tor if you are breast­feed­ing. It is not known if EYLEA may harm your baby. You and your eye doc­tor should de­cide whether you should be treated with EYLEA or breast­feed, but you should not do both How is EYLEA sup­plied? EYLEA is sup­plied in a clear, col­or­less to pale yel­low so­lu­tion con­cen­trated at 40 mg/mL. It is pro­vided in a glass vial con­tain­ing the amount of prod­uct re­quired for a sin­gle in­jec­tion into the eye, which is 0.05 mL (or 2 mg of the medicine prod­uct). Where can I learn more about EYLEA? For more in­for­ma­tion, talk to your eye doc­tor and see the full Pre­scrib­ing In­for­ma­tion at EYLEA.com.

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