There s. to them THAT S WHY THERE S MORE TO GAMUNEX-C

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1 There s more to them THAT S WHY THERE S MORE TO GAMUNEX-C YOUR GUIDE TO CARING FOR SOMEONE WITH CIDP* *Chroic iflammatory demyeliatig polyeuropathy.

TABLE OF CONTENTS What is CIDP?... 4 What causes CIDP?... 5 Why is CIDP sometimes misdiagosed?... 6, 7 What to expect with CIDP... 8 What are the goals of CIDP treatmet?... 9 What is GAMUNEX-C?

2 TABLE OF CONTENTS What is CIDP?... 4 What causes CIDP?... 5 Why is CIDP sometimes misdiagosed?... 6, 7 What to expect with CIDP... 8 What are the goals of CIDP treatmet?... 9 What is GAMUNEX-C? How does GAMUNEX-C work? Is GAMUNEX-C right for CIDP patiets who may have other coditios? How effective is GAMUNEX-C? How is GAMUNEX-C admiistered? Helpful tips for a better ifusio experiece Are there ay side effects with GAMUNEX-C?...16 CIDP Symptom Tracker Gamuex Coexios: Sigle poit of cotact Gamuex Coexios: Savigs ad support Helpful resources...20 CIDP resources ad support Importat Safety Iformatio

3 GET IN THE KNOW ABOUT CIDP Someoe you care for has bee diagosed with chroic iflammatory demyeliatig polyeuropathy (CIDP). The cause of this rare ad progressive autoimmue disease a disease i which the body s immue system attacks healthy cells is uclear. 1 What is clear is that CIDP is treatable ad its symptoms ca be reversed if caught early eough. 2,3 That s why a eurologist has recommeded treatmet with GAMUNEX-C to help improve the CIDP symptoms of the perso you care for. This booklet is desiged to help you help the perso you care for lear about CIDP, treatmet with GAMUNEX-C, ad how Gamuex Coexios ca provide support throughout his/her treatmet jourey. If you have ay questios about this iformatio or about GAMUNEX-C, be sure to talk with a eurologist or a certified urse at Gamuex Coexios. SPEAK WITH A CERTIFIED NURSE AT GAMUNEX CONNEXIONS. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 3

What is CIDP? A rare autoimmue disease CIDP is a rare ad progressive autoimmue disease i which the body s ow immue system attacks the erves i the arms ad legs.

4 What is CIDP? A rare autoimmue disease CIDP is a rare ad progressive autoimmue disease i which the body s ow immue system attacks the erves i the arms ad legs. The most commo symptoms of CIDP are 1,4 : Weakess Numbess Tiglig i legs, arms, figers, ad hads Other symptoms iclude fatigue, pai, balace issues, ad impairmet of ability to walk. 1,4 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. 4,5 You might hear the perso you care for describe THEiR symptoms as... I feel as if there is a lightig storm takig place i my arms ad legs. 4

5 WHAT CAUSES CIDP? Damage to the coverig of the erves Experts are t quite sure why people get CIDP, so there is o kow cause for this disorder. However, they do agree that CIDP begis whe the body s ow immue system attacks ad iflames (swells, irritates) healthy erves ad surroudig cells. This iflammatio ca lead to the damage of myeli, which leads to slowig of erve sigals. 1,2,6 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, messages from the brai to various parts of the body get disrupted. 2,6,7 autoatibodies damaged myeli sheath plasma cell macrophage This disruptio of messages ca cause weakess ad gradual loss of sesatios ad reflexes. Over time, the damage to myeli ad peripheral erves ca lead to disability i the truk, arms, ad legs, ad ca have a egative impact o quality of life. 6 Have ay questios? get aswers from a certified urse at Gamuex Coexios. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 5

6 WHY IS CIDP SOMETIMES MISDIAGNOSED? CIDP ca be hard to diagose It ca be a challege to diagose CIDP because its symptoms resemble those of other ervous system disorders. Because of the similarities with symptoms of other disorders, it ca take up to several moths to obtai a accurate diagosis of CIDP. 1,4,6,8-11 Muscles Legs ad feet Arms ad hads Patter of ivolvemet Progressio of disease CIDP Loss of muscle toe Weak ad ucoordiated with umbess ad tiglig Weak ad ucoordiated with umbess ad tiglig Typically ivolves 2 or more limbs o both sides of the body at the same time Symptom progressio varies from moths to years. Symptoms get worse over time MS Stiffess Weak ad ucoordiated, heavy, ad stiff with umbess ad tiglig Weak ad ucoordiated with umbess ad tiglig Typically ivolves 1 or more limbs o oe side of the body Symptom progressio varies from moths to years. Symptoms get worse over time ALS Stiffess or loss of muscle toe Weak, stiff, or heavy (o umbess or tiglig) Weak (o umbess or tiglig) Symptoms may start i the togue, throat, arms, legs, or breathig muscles Reletless symptom progressio with permaet loss of fuctios GBS May be achy or paiful Weak ad ucoordiated with umbess ad tiglig Weak ad ucoordiated with umbess ad tiglig sesatios i hads Typically starts i the legs ad ca spread to the upper body Symptoms are more sudde (days to weeks). Brief progressio of symptoms followed by slow recovery over moths or years MS = multiple sclerosis; ALS = amyotrophic lateral sclerosis; GBS = Guillai-Barré sydrome. 6

CIDP VS MS, ALS, AND GBS CIDP vs MS While CIDP shares some symptoms with MS, certai symptoms such as problems with cocetratio, visio, speech, ad the bladder are ofte see with MS, but ot with CIDP.

7 CIDP VS MS, ALS, AND GBS CIDP vs MS While CIDP shares some symptoms with MS, certai symptoms such as problems with cocetratio, visio, speech, ad the bladder are ofte see with MS, but ot with CIDP. 8 CIDP vs ALS Although some CIDP symptoms may appear similar to those of ALS, ALS does ot cause umbess, tiglig, or uusual sesatios. Also, ALS commoly causes symptoms such as muscle twitchig, weight loss, ad muscle wastig, as well as problems speakig, breathig, ad swallowig. 9 CIDP vs GBS GBS symptoms quickly develop over days to weeks, ad the slowly get better agai. CIDP symptoms progress gradually over 2 to 6 moths or more. 6 HAVE ANY QUESTIONS ABOUT CIDP? TALK WITH A CERTIFIED NURSE AT GAMUNEX CONNEXIONS. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 7

WHAT TO EXPECT WITH CIDP CIDP gets progressively worse without treatmet Iitially, people with CIDP may simply be aware that it takes more effort to do the thigs they used to do.

8 WHAT TO EXPECT WITH CIDP CIDP gets progressively worse without treatmet Iitially, people with CIDP may simply be aware that it takes more effort to do the thigs they used to do. Over several moths the symptoms may progress to the poit that the perso you care for may o loger be able to do simple daily activities. 6 Without treatmet, permaet erve damage that leads to disability ca occur. Whe this happes, quality of life suffers ad everyday tasks like climbig stairs, walkig, reachig for items, ad liftig objects overhead ca become difficult to perform. 3,6 It is critical to treat CIDP immediately because permaet erve damage caot be reversed 8

9 WHAT are THE GOALs OF CIDP TREATMENT? Reduce symptoms ad preserve physical idepedece The goals of treatmet for CIDP are to reduce symptoms (weakess, sesory loss, imbalace, ad pai), improve physical-fuctioal ability (coordiatio, stregth, ad balace), ad reach ad maitai log-term remissio (disappearace of symptoms). 12 Helpful tips for the maagemet of CIDP CIDP must be treated to prevet disability ad to potetially reduce the eed for wheelchairs, walkers, ad other assistive devices Timely ad close follow-up care is ecessary to adjust treatmet Regular cosultatios with a eurologist are recommeded Physical therapy ad a active lifestyle are ecouraged Joi CIDP support groups for up-to-date sharig of iformatio with other patiets ad their families TO LEARN MORE ABOUT WHAT TO EXPECT WITH CIDP, SPEAK WITH A CERTIFIED NURSE AT GAMUNEX CONNEXIONS. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 9

WHAT IS GAMUNEX-C? GAMUNEX-C is the first FDA-approved IVIG treatmet for CIDP GAMUNEX-C is a itraveous immue globuli (IVIG) therapy for the treatmet of adult patiets with CIDP.

10 WHAT IS GAMUNEX-C? GAMUNEX-C is the first FDA-approved IVIG treatmet for CIDP GAMUNEX-C is a itraveous immue globuli (IVIG) therapy for the treatmet of adult patiets with CIDP. Immue globulis are healthy atibodies that come from doated huma plasma. Plasma is the liquid part of the blood ad cotais atibodies eeded to keep you healthy. 13,14 This doated huma plasma is collected i licesed US plasma door ceters that are strictly moitored by Grifols ad the FDA. Each plasma door ad plasma doatio is carefully screeed to help make sure that the fial product is safe for use. It takes about 130 plasma doatios to treat 1 patiet for 1 year. 14 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. 10

11 HOW DOES GAMUNEX-C WORK? Everyoe has protei molecules i their body called atibodies that are part of the body s immue system. These atibodies idetify ad kill bacteria, fugi, parasites, viruses, ad other foreig ivaders that may harm the body. 13 A additioal role of the immue system is to heal the body after ijury. Treatmet with GAMUNEX-C 3,6 1. Provides healthy atibodies to block the immue ad iflammatory processes 2. Protects erves ad their protective myeli coverig Atibodies Myeli Nerve The way i which GAMUNEX-C works i treatmet of people with CIDP is ot completely uderstood

12 IS GAMUNEX-C RIGHT FOR CIDP PATIENTS WHO MAY HAVE OTHER CONDITIONS? GAMUNEX-C has bee approved for the treatmet of CIDP eve i patiets who may have other coditios such as diabetes, heart complicatios, ad kidey problems. 16 Because of this, treatmet with GAMUNEX-C may meet the eeds of a lot of differet people with CIDP. 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. 16 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. 16 I a exteded phase of a cliical study, people give Gamuex-C who achieved sustaied remissio did ot drop out 17 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 effects i cliical studies were a blood clot to the lug (pulmoary embolism) i 1 patiet with a history of this coditio (i CIDP). 12

13 HOW EFFECTIVE IS GAMUNEX-C? The effectiveess of GAMUNEX-C was established i a ladmark cliical trial kow as the ICE* study. This study, the logest reported trial of ay CIDP treatmet, showed that GAMUNEX-C was effective for the short-term ad log-term treatmet of CIDP. 17 GAMUNEX-C i the ICE study showed 17 : Sigificat improvemet i disability scores through 24 weeks Improved grip stregth i both hads 87% of patiets were relapse-free at 48 weeks HAVE QUESTIONS ABOUT TREATMENT WITH GAMUNEX-C? TALK WITH A CERTIFIED NURSE AT GAMUNEX CONNEXIONS. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 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. *ICE = 10% caprylate-chromatography purified immue globuli itraveous (IGIV-C) CIDP efficacy. 13

HOW IS GAMUNEX-C ADMINISTERED? 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.

14 HOW IS GAMUNEX-C ADMINISTERED? 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 The first ifusio of GAMUNEX-C for the perso you care for may occur over the course of 2 days or loger. Durig this time, a healthcare professioal will be closely moitorig his/her health status to esure that he/she is toleratig GAMUNEX-C After the first ifusio, admiistratio of GAMUNEX-C usually takes 2 to 4 hours from start to fiish The perso you care for should cosider brigig somethig to occupy his/her time like a game, book, or tablet A eurologist or ifusio urse may ask you to help the perso you care for keep track of how he/she is feelig so that the best treatmet schedule ca be determied The umber of ifusios that the perso you care for receives will be determied by his/her eurologist, depedig o idividual eed TO SEE A VIDEO ON HOW GAMUNEX-C IS ADMINISTERED, VISIT GAMUNEX-C.COM. 14

15 HELPFUL TIPS FOR A BETTER INFUSION EXPERIENCE Preparig for ifusio Be sure to iform the eurologist or urse of ay medicatios the perso you care for is takig Make sure the perso you care for driks a lot of fluids ad icreases fluid itake 24 hours before ifusio Additioally, the eurologist or urse might tell the perso you care for to take over-the-couter medicatios 30 miutes before the ifusio starts to help prevet possible headache, rash, or itchig to avoid discomfort Durig ifusio Be sure the perso you care for dresses i comfortable clothes Make sure all ecessary forms have bee filled out ad completed Tell the eurologist or urse if the perso you care for is feelig discomfort After ifusio Note ay improvemets or worseig of symptoms (o matter how big or how small) Share your observatios with the eurologist TO HAVE A BETTER INFUSION EXPERIENCE, SPEAK WITH A CERTIFIED NURSE AT GAMUNEX CONNEXIONS. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 15

16 ARE THERE ANY SIDE EFFECTS WITH GAMUNEX-C? All medicies have risks ad side effects. Ad, treatmets for CIDP are ot a exceptio to this. Be sure the perso you care for speaks with a eurologist about these commo side effects of GAMUNEX-C. The most commo side effects for patiets with CIDP takig GAMUNEX-C were 15 : 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 the ski such as the 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 15 : Blood clots i the lugs (pulmoary embolism) Have questios about potetial side effects? TALk with a certified urse at Gamuex Coexios. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 16

17 CIDP SYMPTOM TRACKER To get the most from treatmet with GAMUNEX-C, use this Symptom Tracker to record how the perso you care for is feelig. Ad, make sure he/she shares the fidigs o matter how big or small with his/her eurologist so that treatmet plas ca be adjusted for best results. Please idicate how true each statemet has bee* Not at all = 0 A little bit = 1 A lot = 2 Date of weekly or mothly completio / / / / / / / / I am frustrated by my CIDP I am bothered by pai from CIDP I am off-balace whe walkig because of my CIDP I have trouble gettig dressed because of my CIDP I have trouble sleepig because of my CIDP I am bothered by my limitatios i performig work (icludig work at home) because of my CIDP I have trouble drivig because of my CIDP I am depedet o others because of my CIDP I am depressed about my CIDP I have falle because of my CIDP I am preoccupied because of my CIDP I am uable to do all the leisure activities that I wat to do because of my CIDP I am wor out because of my CIDP I have trouble eatig because of my CIDP I have trouble doig activities aroud the house because of my CIDP Total score *Adapted from Gwathmey KG, et al. 18 To dowload additioal Symptom Tracker forms, go to GAMUNEX-C.com. 17

GAMUNEX CONNEXIONS: SINGLE POINT OF CONTACT A dedicated Gamuex Coexios specialist uderstads that the key to uiterrupted treatmet is to have a strog support team behid the perso you care for.

18 GAMUNEX CONNEXIONS: SINGLE POINT OF CONTACT A dedicated Gamuex Coexios specialist uderstads that the key to uiterrupted treatmet is to have a strog support team behid the perso you care for. Dedicated support durig treatmet with GAMUNEX-C Helps idetify the best available beefits coverage for GAMUNEX-C Provides educatioal iformatio ad resources to address healthcare eeds Support from a certified urse whe eeded Aswers questios about GAMUNEX-C: how it works, what to expect, ad much more Provides iformatio ad support to maage CIDP 18

GAMUNEX CONNEXIONS: SAVINGS AND SUPPORT At Gamuex Coexios, our first priority is to provide high-value treatmet ad fiacial support that will help people stay o track with their treatmet pla.

19 GAMUNEX CONNEXIONS: SAVINGS AND SUPPORT At Gamuex Coexios, our first priority is to provide high-value treatmet ad fiacial support that will help people stay o track with their treatmet pla. Copay assistace is available to eligible patiets Get help with maagig: Deductibles Copaymet Coisurace Fiacial support Through our patiet assistace program, eligible patiets may receive GAMUNEX-C at o cost i the evet of: Loss of isurace Sig up for Gamuex Coexios ad lear how to save up to $2500 over 12 moths. Your dedicated cotact is oly a phoe call away. Call MYGAMUNEX ( ) Moday through Friday (8 am to 8 pm ET) 19

15 7 To lear more about GAMUNEX-C ad Gamuex Coexios, visit GAMUNEX-C.com.

Please see Importat Safety Iformatio o pages 6 ad 7, ad refer 2018 Grifols All rights reserved Jauary 2018 US/GX/0515/0099(4)a THAT S WHY THERE S MORE TO GAMUNEX-C *CIDP=Chroic iflammatory

Please see Importat Safety Iformatio o pages 12 ad 13, ad refer For trackig my treatmet progress with GAMUNEX-C Get the most out of your treatmet with GAMUNEX-C by followig these simple steps to

Sharig these results ca help your doctor look for ay chages i your CIDP symptoms ad fid the best treatmet regime for you.

20 15 7 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 2018 Grifols All rights reserved April 2018 US/GX/0515/0099(4) To lear more about GAMUNEX-C ad Gamuex Coexios, visit GAMUNEX-C.com. Please see Importat Safety Iformatio o pages 6 ad 7, ad refer 2018 Grifols All rights reserved Jauary 2018 US/GX/0515/0099(4)a THAT S WHY THERE S MORE TO GAMUNEX-C *CIDP=Chroic iflammatory demyeliatig polyeuropathy. Please see Importat Safety Iformatio o pages 12 ad 13, ad refer For trackig my treatmet progress with GAMUNEX-C Get the most out of your treatmet with GAMUNEX-C by followig these simple steps to record ad discuss your symptoms: Prit out this form Complete the survey Share the results with your doctor Use this form oce a week for the first 3 moths of treatmet, ad use it oce a moth after that. Sharig these results ca help your doctor look for ay chages i your CIDP symptoms ad fid the best treatmet regime for you. Please idicate how true each statemet has bee* Not at all = 0 A little bit = 1 A lot = 2 Date of weekly or mothly completio / / / / / / / / I am frustrated by my CIDP I am bothered by pai from CIDP I am off balace whe walkig because of my CIDP I have trouble gettig dressed because of my CIDP I have trouble sleepig because of my CIDP I am bothered by my limitatios i performig work (icludig work at home) because of my CIDP I have trouble drivig because of my CIDP I am depedet o others because of my CIDP I am depressed about my CIDP I have falle because of my CIDP I am preoccupied with my CIDP I am uable to do all the leisure activities that I wat to do because of my CIDP I am wor out because of my CIDP I have trouble eatig because of my CIDP I have trouble doig activities aroud the house Total score *Adapted from Gwathmey KG, et al. 1 Make sure to discuss your resposes ad your total score with your doctor. Please see Importat Safety Iformatio o the reverse side ad refer THAT S WHY THERE S MORE TO GAMUNEX-C *Chroic iflammatory demyeliatig polyeuropathy. Please see Importat Safety Iformatio o pages 6 ad 7, ad refer HELPFUL RESOURCES Educatioal tools These educatioal resources are provided to help you ad the perso you care for lear more about CIDP ad its symptoms, ad to help you have a more iformed coversatio with a eurologist. To access these materials, visit GAMUNEX-C.com. There s more to you YOUR GUIDE TO UNDERSTANDING THE TREATMENT OF CIDP * Uderstadig the Treatmet of CIDP Guide Iformatio o what to expect with CIDP ad iitial treatmet with GAMUNEX-C. 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): My CIDP Symptom Tracker CIDP Symptom Tracker Use this Symptom Tracker to record the results of the perso you care for. Make sure to share with his/her eurologist. There s more to you YOUR GUIDE FOR THE LONG-TERM TREATMENT OF CIDP * Log-term Treatmet of CIDP Guide Iformatio o what to expect as the perso you care for moves further alog i his/her CIDP treatmet jourey. 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 Refereces: 1. 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 placebo-cotrolled trial. Lacet Neurol. 2008;7(2): Merkies IS, Bril V, Dalakas MC, et al; o behalf of the ICE Study Group. Health-related quality-of-life improvemets i CIDP with immue globuli IV 10%. Neurology. 2009;72(15): Gamuex Coexios Brochure A overview of the treatmet ad fiacial support resources that are available to the perso you care for. 20

21 CIDP resources ad support The CIDP advocacy orgaizatios below are iteded to coect you ad the perso you care for 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. GAMUNEX CONNEXIONS TOOLS & RESOURCES Your source for patiet-focused educatioal materials, tools, ad videos. * Grifols does ot edorse ad is ot resposible for the cotet provided by these resources about treatmet ad patiet-support groups. 21

22 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. 22

23 IMPORTANT SAFETY INFORMATION (cot d) 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 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. FPO 23

24 IMPORTANT SAFETY INFORMATION (cot d) 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 FPO 24

25 Refereces: 1. Chroic iflammatory demyeliatig polyradiculoeuropathy. Uiversity of Rochester Medical Ceter website. aspx?cotettypeid=134&cotetid=210. Accessed Jauary 9, Chroic iflammatory demyeliatig polyeuropathy. Natioal Istitutes of Health website. article/ htm. Accessed Jauary 9, Köller H, Kieseier BC, Jader S, Hartug HP. Chroic iflammatory demyeliatig polyeuropathy. N Egl J Med. 2005;352(13): Chroic iflammatory demyeliatig polyeuropathy (CIDP). Uiversity of Chicago Ceter for Peripheral Neuropathy website. iflammatory/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): Koski CL. CIDP: Chroic Iflammatory Demyeliatig Polyeuropathy. Narberth, PA: GBS/CIDP Foudatio Iteratioal; Evers E, Hughes R, Rialdi S. CIDP ad the Chroic Variats. Sleaford, UK: Guillai-Barré & Associated Iflammatory Neuropathies (GAIN); Multiple sclerosis: symptoms ad causes. Mayo Cliic website. Accessed February 23, Amyotrophic lateral sclerosis: symptoms ad causes. Mayo Cliic website. dxc ?p=1. Accessed February 23, Amyotrophic lateral sclerosis (ALS) fact sheet. Natioal Istitute of Neurological Disorders ad Stroke website. Patiet-Caregiver-Educatio/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet#Symptoms. Accessed February 23, Guillai-Barré sydrome overview. New York Times. May 21, Accessed February 2, Gorso KC. A update o the maagemet of chroic iflammatory demyeliatig polyeuropathy. Ther Adv Neurol Disord. 2012;5(6): 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. 15. GAMUNEX -C (immue globuli ijectio [huma], 10% caprylate/chromatography purified) Prescribig Iformatio. Grifols. 16. 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 placebo-cotrolled trial. Lacet Neurol. 2008;7(2): Gwathmey KG, Coaway MR, Sadjadi R, et al. Costructio ad validatio of the chroic acquired polyeuropathy patiet-reported idex (CAP-PRI): a disease-specific, health-related quality-of-life istrumet. Muscle Nerve. 2016;54(1):

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

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