There s. more. to you THAT S WHY THERE S MORE TO GAMUNEX-C. *CIDP=Chronic inflammatory demyelinating polyneuropathy.

Transcription

1 There s more to you THAT S WHY THERE S MORE TO GAMUNEX-C YOUR GUIDE TO UNDERSTANDING THE TREATMENT OF CIDP * *CIDP=Chroic iflammatory demyeliatig polyeuropathy. Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

2 What is CIDP? CIDP is a rare ad progressive autoimmue disease i which the body s ow immue system attacks the erves i the arms ad legs. 1 The most commo symptoms of CIDP are 1,2 : Weakess Numbess Tiglig i the legs, arms, figers, ad hads Other symptoms iclude fatigue, pai, balace issues, ad impairmet of ability to walk. 1,2 The symptoms of CIDP usually occur o both sides of the body at the same time. But sometimes oly oe side is ivolved. These symptoms ca be mild, moderate, or severe ad ca chage i severity over time. 2,3 2 Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

3 WHAT CAUSES CIDP? CIDP occurs whe myeli, the protective coverig of the peripheral erves (erves located outside of the brai ad spial cord), is damaged by the body s ow immue system. 4,5 AUTOANTIBODIES DAMAGED MYELIN SHEATH PLASMA CELL MACROPHAGE Damage to erves ad their myeli coverig meas that messages from the brai to various parts of the body get disrupted, ad this ca cause weakess ad gradual loss of sesatios ad reflexes. Over time, this damage may lead to disability i the arms ad legs, ad ca have a egative impact o quality of life. 6 3

4 How Is CIDP treated? While there is o kow cure for CIDP, it ca be treated ad symptoms may be reversed if caught early eough. It is critical to talk to a eurologist immediately because permaet erve damage caot be reversed. 4,7 sed. 1 There are 4 mai treatmets for CIDP 1. IVIG*: Healthy proteis called immuoglobulis are ifused ito your blood. They block the immue system from attackig myeli 4,6 r 2. Corticosteroids: Medicies that decrease iflammatio ad slow dow the immue system 8,9 r 3. Plasmapheresis: A plasma exchage where blood is cleaed to remove atibodies that attack myeli Immuosuppressats: Medicies that prevet your immue system from fuctioig so it caot attack your myeli 1,11 *IVIG=itraveous immuoglobuli. IVIG=Itraveous immuoglobuli. 4 Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

5 What is GAMUNEX-C? GAMUNEX-C is a immue globuli therapy for the treatmet of adult patiets with CIDP. Immue globulis are healthy atibodies that come from doated huma plasma. 12,13 Plasma is the liquid part of the blood ad cotais atibodies eeded to keep you healthy. 13 GAMUNEX-C is the #1 prescribed immue globuli therapy for CIDP 13 I people with CIDP, it s believed that GAMUNEX-C provides healthy atibodies to block the immue ad iflammatory processes that attack ad destroy the protective coverig aroud the erve fibers. ANTIBODIES MYELIN NERVE The way i which GAMUNEX-C works i treatmet of people with CIDP is ot completely uderstood. 14 Do ot take GAMUNEX-C if you have a allergy to immue globuli. Tell your doctor if you have had a serious reactio to other medicies that cotai huma immue globuli. Also tell your doctor if you have immuoglobuli A (IgA) deficiecy. If you have a serious reactio while takig GAMUNEX-C, stop takig it immediately ad tell your doctor. 5

6 Who is GAMUNEX-C made for? GAMUNEX-C may be a optio for people with CIDP who have other coditios such as diabetes, heart complicatios, ad kidey problems. 15 Because of this, treatmet with GAMUNEX-C may meet the eeds of a variety of CIDP patiet types. A optio for CIDP patiets who have diabetes Immue globuli (IG) therapies cotaiig sugar stabilizers are more likely to iterfere with diabetes treatmets ad cause kidey-related side effects. GAMUNEX-C cotais o sugar ad o preservatives. 15 A optio for CIDP patiets who have heart coditios Icreased salt cotet may icrease the risk of swellig, fluid overload, ad cogestive heart failure. GAMUNEX-C cotais oly trace amouts of salt. 15 I a cliical study with CIDP patiets who got GAMUNEX-C itraveously, the most commo side effects were pai i the regio of the head or eck; raised body temperature or fever; abormally high blood pressure; feeligs of coldess accompaied by shiverig; a oticeable chage i the texture or color of your ski such as your ski becomig scaly, bumpy, itchy, or otherwise irritated; a sesatio of uease ad discomfort i the upper stomach; joit pai; ad abormal physical weakess or lack of eergy. The most serious side effect i CIDP was a blood clot to the lug (pulmoary embolism) i 1 patiet with a history of this coditio. 6 Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

7 Will GAMUNEX-C work for me? While there is o cure for CIDP, it ca be treated, ad may patiets feel a improvemet i symptoms of weakess, umbess, ad poor balace after just 3 weeks. I cliical studies, GAMUNEX-C was show to improve euromuscular disability ad impairmet. I the ladmark ICE* trial the logest IVIG study for CIDP people treated with GAMUNEX-C demostrated 16 : Sigificat improvemet i disability scores through 24 weeks Improved grip stregth i both hads Oh my gosh, I CAN ACTUALLY PICK UP a plate ad take it to a table at my restaurat. _ Ale, treated with GAMUNEX-C Because GAMUNEX-C is made from huma blood, it may carry a risk of trasmittig ifectious agets such as viruses, the variat Creutzfeldt-Jakob disease (vcjd) aget, ad, theoretically, the Creutzfeldt-Jakob disease (CJD) aget. *ICE=caprylate-chromatography purified immue globuli itraveous (IGIV-C) CIDP efficacy. 7

8 How is GAMUNEX-C admiistered? GAMUNEX-C is admiistered itraveously (IV) through a vei, typically i the arm. It ca be take at a ifusio ceter, hospital, or i the coveiece of the home. Preparig for itraveous therapy Your first ifusio of GAMUNEX-C may occur over the course of 2 days or loger. Durig this time, your healthcare professioal will be closely moitorig your health status to esure that you are toleratig GAMUNEX-C Make sure you drik lots of fluids ad icrease your fluid itake 24 hours before ifusio After your first ifusio, admiistratio of GAMUNEX-C usually takes 2 to 4 hours from start to fiish Cosider brigig somethig to occupy your time, like a game, book, or tablet Your eurologist or ifusio urse may ask you to keep track of how you re feelig so that he/she ca determie the treatmet schedule that is right for you To s a video o how GAMUNEX-C is admiistered, visit GAMUNEX-C.com. 8 Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

9 ARE THERE SIDE EFFECTS WITH GAMUNEX-C? All medicies have risks ad side effects. Ad, treatmets for CIDP are ot a exceptio to this. Be sure to speak with a eurologist about these commo side effects of GAMUNEX-C. The most commo side effects for CIDP patiets takig GAMUNEX-C were 16 : Pai i the regio of the head or eck Raised body temperature or fever Abormally high blood pressure Feeligs of coldess ad/or shiverig Noticeable chage i the texture or color of your ski such as your ski becomig scaly, bumpy, itchy, or otherwise irritated Sesatio of uease ad discomfort i the upper stomach Joit pai Abormal physical weakess or lack of eergy Although very rare, treatmet with GAMUNEX-C may cause serious side effects such as 14 : Blood clots i the lugs (pulmoary embolism) Have questios about potetial side e ects? Speak with a certified urse at Gamuex Co exios. Call MYGAMUNEX ( ) Moday through Friday (8 AM to 8 PM ET) 9

10 YOUR TREATMENT SUPPORT PARTNER Your dedicated Gamuex Coexios specialist uderstads that the key to uiterrupted treatmet is to have a strog support team behid you. Dedicated support for you durig your treatmet with GAMUNEX-C Helps idetify the best available beefits coverage for GAMUNEX-C Provides educatioal iformatio ad resources to address your healthcare eeds Support from a certified urse whe you eed it Aswers questios about GAMUNEX-C: how it works, what to expect, ad much more Provides iformatio ad support to help you maage your coditio 10 Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

11 YOUR FINANCIAL SUPPORT PARTNER You may have questios about your treatmet ad how you re goig to afford your therapy. At Gamuex Coexios we re committed to helpig you get ad stay o therapy. Copay assistace is available to eligible patiets Get help with maagig: Deductibles Copaymet Coisurace Fiacial support Through our patiet assistace program, you may be qualified to receive GAMUNEX-C at o cost i the evet of: Loss of isurace Uderisurace Sig up for Gamuex Coexios ad lear how you ca save up to $2500 over 12 moths. Your regioal cotact is oly a phoe ca away Call MYGAMUNEX ( ) Moday through Friday (8 AM to 8 PM ET) 11

12 IMPORTANT SAFETY INFORMATION GAMUNEX -C (immue globuli ijectio [huma], 10% caprylate/chromatography purified) is approved to treat primary humoral immuodeficiecy disease (PIDD) i patiets 2 years of age ad older. If you have PIDD, you may take GAMUNEX-C uder the ski (subcutaeously) or i a vei (itraveously). GAMUNEX-C is also approved to treat idiopathic thrombocytopeic purpura (ITP) i adults ad childre ad chroic iflammatory demyeliatig polyeuropathy (CIDP) i adults. If you have ITP or CIDP, you may oly take GAMUNEX-C itraveously. If you take GAMUNEX-C or a similar immue globuli product, you could experiece a serious ad life-threateig blood clot (thromboembolism), which may iclude pai ad/or swellig of a arm or leg with warmth over the affected area, discoloratio of a arm or leg, uexplaied shortess of breath, chest pai or discomfort that worses o deep breathig, uexplaied rapid pulse, umbess, or weakess o oe side of the body. You are more likely to develop a blood clot if you have a history of hardeig of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart). You may also be more likely to get a blood clot if you are elderly, if you have a blood clottig disorder, if you are iactive for log periods of time (such as log bed rest), if you use estroges, or if you have thickeig of your blood. For patiets at risk, GAMUNEX-C should be admiistered at the lowest dose ad slowest ifusio rate that is practical. However, blood clots may occur i the absece of ay of the kow risk factors. Patiets should be well hydrated by drikig eough water before GAMUNEX-C is admiistered. Tell your doctor immediately if your medical history is similar to what is described here, ad especially if you start havig ay of these symptoms while takig GAMUNEX-C. If you take GAMUNEX-C or a similar immue globuli product itraveously, you could experiece serious kidey disease ad death. You may have symptoms of decreased uriatio, sudde weight gai, swellig i your legs (edema), or shortess of breath. You are more likely to develop serious kidey disease if you already have a kidey problem, have Type II diabetes mellitus, or are older tha 65. You are more likely to develop serious kidey disease if you are dehydrated, have a blood ifectio (sepsis), have high protei cotet i your blood, or if you are receivig other medicies that are harmful to your kideys. Tell your doctor immediately if your medical history is similar to what is described here, ad especially if you start havig ay of these symptoms while takig GAMUNEX-C. You are more likely to develop serious kidey disease if you take a itraveous immue globuli product that cotais sugar (sucrose). GAMUNEX-C does ot cotai sugar. If your situatio makes you more likely to experiece serious kidey disease, you should take GAMUNEX-C at the lowest cocetratio available ad the slowest ifusio rate that is practical. Do ot take GAMUNEX-C if you have a allergy to immue globuli. Tell your doctor if you have had a serious reactio to other medicies that cotai huma immue globuli. Also tell your doctor if you have immuoglobuli A (IgA) deficiecy. If you have a serious reactio while takig GAMUNEX-C, stop takig it immediately ad tell your doctor. Periodic moitorig of kidey fuctio ad urie output is particularly importat i patiets more likely to experiece severe kidey disease. You could experiece other serious ad life-threateig problems due to immue globuli. You could get aseptic meigitis (a type of brai iflammatio with symptoms of severe headache, stiff eck, fatigue, fever, sesitivity to light, paiful eye movemets, ausea, ad vomitig), a blood problem called hemolytic aemia (commo symptoms iclude icreased heart rate, fatigue, yellow ski or eyes, ad 12

13 dark-colored urie), ad/or a lug problem called trasfusio-related acute lug ijury (commoly referred to as TRALI). TRALI is a coditio where you build up fluid i the lugs (called pulmoary edema) that is ot the result of heart failure. If you have higher tha ormal body fluid volumes or if you have a coditio where icreasig body fluid volume may be a cocer, a higher dose, such as 1g/kg for 1-2 days, is ot recommeded. Because GAMUNEX-C is made from huma blood, it may carry a risk of trasmittig ifectious agets such as viruses, the variat Creutzfeldt-Jakob disease (vcjd) aget, ad, theoretically, the Creutzfeldt-Jakob disease (CJD) aget. You may ot take GAMUNEX-C subcutaeously if you have ITP. If you have ITP ad take GAMUNEX-C subcutaeously, you could experiece a very serious ad life-threateig black ad blue woud (hematoma, which is a pocket of blood withi a tissue). After you take GAMUNEX-C, your blood atibody levels may rise, which could cause some blood atibody tests to give false results. The most commo side effects i a cliical study with PIDD patiets who got subcutaeous ijectios of GAMUNEX-C were ifusio-site reactios such as redess, swellig, ad itchig; extreme tiredess; pai i the regio of the head or eck; a ruy ose, asal cogestio, seezig, cough, ad sputum productio; joit pai; loose stools; a sesatio of uease ad discomfort i the upper stomach; swellig of the tissue liig the siuses; iflammatio of the airways that carry air to your lugs; a feelig of uhappiess, sadess, melacholy, gloom, hopelessess, or low spirits; red rash or bumps, itchy, swolle, ad teder ski with or without blisters or a burig feelig; a severe throbbig pai or a pulsig sesatio, usually o just oe side of the head; muscle pai; familiar ifectious diseases such as the commo cold or flu; ad raised body temperature or fever. I cliical studies with PIDD patiets who got GAMUNEX-C itraveously, the most commo side effects were cough; irritatio ad iflammatio of the mucous membrae iside the ose; sore throat caused by iflammatio of the back of the throat; pai i the regio of the head or eck; a coditio i which your airways arrow ad swell ad produce extra mucus; a sesatio of uease ad discomfort i the upper stomach; raised body temperature or fever; loose stools; ad swellig of the tissue liig the siuses. I a cliical study with CIDP patiets who got GAMUNEX-C itraveously, the most commo side effects were pai i the regio of the head or eck; raised body temperature or fever; abormally high blood pressure; feeligs of coldess accompaied by shiverig; a oticeable chage i the texture or color of your ski such as your ski becomig scaly, bumpy, itchy, or otherwise irritated; a sesatio of uease ad discomfort i the upper stomach; joit pai; ad abormal physical weakess or lack of eergy. I cliical trials with ITP patiets who got GAMUNEX-C itraveously, the most commo side effects were pai i the regio of the head or eck; a discoloratio of the ski resultig from bleedig udereath, typically caused by bruisig; vomitig, fever, ausea, rash, abdomial pai, back pai, ad a pai or a ucomfortable feelig i the upper middle part of your stomach. The most serious side effects i cliical studies were a blood clot to the lug (pulmoary embolism) i 1 patiet with a history of this coditio (i CIDP), a flare-up of a existig type of aemia (autoimmue pure red cell aplasia) i 1 patiet (i PIDD), ad heart iflammatio (myocarditis) i 1 patiet (i ITP). Please see accompayig full Prescribig Iformatio for GAMUNEX-C. You are ecouraged to report egative side effects of prescriptio drugs to the FDA. Visit or call FDA

14 CIDP resources ad support* The CIDP advocacy orgaizatios below are iteded to coect you to additioal educatioal resources about treatmet. GBS/CIDP FOUNDATION INTERNATIONAL GBS/CIDP Foudatio Iteratioal provides support ad assistace to patiets with Guillai-Barré sydrome (GBS) ad CIDP, ad their families. FOUNDATION FOR PERIPHERAL NEUROPATHY The Foudatio for Peripheral Neuropathy is the leadig atioal oprofit orgaizatio servig the peripheral europathy commuity. * Grifols does ot edorse ad is ot resposible for the cotet provided by these resources about treatmet ad patiet-support groups. 14 Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C.

15 Refereces: 1. Chroic iflammatory demyeliatig polyradiculoeuropathy. Uiversity of Rochester Medical Ceter website. Accessed Jauary 9, Chroic iflammatory demyeliatig polyeuropathy (CIDP). Uiversity of Chicago Ceter for Peripheral Neuropathy website. cidp.shtml. Accessed February 16, Gorso KC, Gooch CL. The (mis)diagosis of CIDP: the high price of missig the mark. Neurology. 2015;85(6): Chroic iflammatory demyeliatig polyeuropathy. Natioal Istitutes of Health website. Accessed Jauary 9, Evers E, Hughes R, Rialdi S. CIDP ad the Chroic Variats. Sleaford, UK: Guillai-Barré & Associated Iflammatory Neuropathies (GAIN); Koski CL. CIDP: Chroic Iflammatory Demyeliatig Polyeuropathy. Narberth, PA: GBS/CIDP Foudatio Iteratioal; Köller H, Kieseier BC, Jader S, Hartug HP. Chroic iflammatory demyeliatig polyeuropathy. N Egl J Med. 2005;352(13): Corticosteroid (oral route, pareteral route). Mayo Cliic website. drg ?p=1. Accessed February 24, Steroids. NHS Choices website. corticosteroid-(drugs)/pages/itroductio.aspx. Accessed February 24, Plasmapheresis. Natioal Multiple Sclerosis Society website. Accessed March 10, Treatig lupus with immuosuppressive medicatios. Johs Hopkis Medicie website. hopkislupus.org/lupus-treatmet/lupus-medicatios/immuosuppressive-medicatios/. Accessed February 24, Natioal Istitutes of Health. Uderstadig the Immue System: How It Works. Bethesda, MD: Natioal Istitutes of Health, US Dept of Health ad Huma Services; Data o file, Grifols. 14. GAMUNEX -C (immue globuli ijectio [huma], 10% caprylate/chromatography purified) Prescribig Iformatio. Grifols. 15. Gelfad EW. Differeces betwee IGIV products: impact o cliical outcome. It Immuopharmacol. 2006;6(4): Hughes RAC, Doofrio P, Bril V, et al; o behalf of the ICE Study Group. Itraveous immue globuli (10% caprylate-chromatography purified) for the treatmet of chroic iflammatory demyeliatig polyradiculoeuropathy (ICE study): a radomised placebocotrolled trial. Lacet Neurol. 2008;7(2):

16 To lear more about GAMUNEX-C ad Gamuex Coexios, visit GAMUNEX-C.com. Please see Importat Safety Iformatio o pages 12 ad 13, ad refer to accompayig full Prescribig Iformatio for GAMUNEX-C Grifols All rights reserved April 2018 US/GX/0515/0099(4)