NeedyMeds

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1 NeedyMeds Find help with the cost of medicine Thank you for downloading this patient assistance document from NeedyMeds. We hope this program will help you get the medicine you need. REMEMBER - Send your completed application to address on the form, NOT to NeedyMeds. Did you know that NeedyMeds has thousands of other free resources? Here s a look at more ways we can help you save money on medicine and healthcare costs. Each one can be found under the Patient Savings tab on our website: Diagnosis-Based Assistance NeedyMeds lists thousands of assistance programs for almost any health condition. If you are going through chemo treatment for cancer, there are programs that can help with wig costs and scalp-cooling products. We also list resources for free diabetes testing supplies, caregiver lodging support, and much more. Free, Low Cost, and Sliding Scale Clinics This popular collection contains information on 16,000+ free, low cost, and sliding scale medical and dental clinics across the U.S. It s a great resource if you need affordable medical treatment and don t know where to go. Coupons, Rebates & More You can use the NeedyMeds website to find nearly 2,000 cost-saving opportunities for both prescription and over-the-counter drugs and medical supplies. Medical Transportation Need help getting to the doctor s office or medical facility? You may be eligible for financial assistance if you meet certain requirements. Finally, I want to tell you about the NeedyMeds Drug Discount Card. Thousands of people use this free, anonymous, and easy-to-use tool to get the best price on their medications. To date, our drug discount card has saved patients over $244,000,000. Check out the next page to learn more. Feel free to call our toll-free helpline if you have any questions. You can reach us at Monday-Friday, 9am-5pm Eastern Time. Thanks for using NeedyMeds! Please let us know if we can do anything else to help you afford the costs of your healthcare. Rich Sagall, MD Richard J. Sagall, MD President, NeedyMeds NeedyMeds.org P.O. Box 219 Gloucester, MA Phone: info@needymeds.org

2 Clip the card and save NeedyMeds NeedyMeds.org DRUG DISCOUNT CARD BIN: RX PCN: NMEDS RX GRP: PDFPDF ID: NMNA This is a drug discount program, not an insurance plan. NeedyMeds Drug Discount Card Patient: Simply present this card to a participating pharmacy to receive a discount on your prescription. Patients who have Medicare, including Part D, Medicaid or any state or federal prescription insurance can only use this card if they choose not to use their government-sponsored drug plan for their purchase. The card is not valid in combination with those programs. For questions concerning the card, call or visit Pharmacist: Card must be presented to receive program benefits. Clear system of prior cardholder information associated with this universal cardholder ID. For processing questions, call Argus Health Systems at Save up to 80% Use at over 65,000 pharmacies nationwide including all major chains Share the card with friends and family Use the card as often as needed Free, no fees or registration Never expires What if I have insurance? Anyone can use the card, but it can t be combined with insurance. You can use the card instead of insurance if: A drug isn t covered by your insurance Your insurance has no drug coverage You have a high drug deductible You have met a low medicine cap The card offers a better price than your copay You are in the Medicare Part D donut hole What drugs are covered? The card is good for prescription drugs, over-the-counter medicines and medical supplies if written on a prescription blank, and pet prescription medicines purchased at a pharmacy. You ll save on most, but not all, prescriptions. To obtain a plastic drug discount card, send a self-addressed stamped envelope to: NeedyMeds-PAP PO Box 219 Gloucester, MA The card is not valid in combination with other insurance plans, including Medicare, Medicaid or any state or federal prescription insurance. The card can be used only if you decide not to use your government-sponsored drug plan for your purchases.

3 Support for living hands-on Nancy Travel enthusiast living with PI Program details inside. MyIgSource is open to all Primary Immunodeficiency (PI) patients and caregivers regardless of treatment. Please see Indication and Important Safety Information on pages 10 11, 14 15, and and FDA-approved patient labeling.

4 About the Program Life is full of beginnings, and a Primary Immunodeficiency (PI) diagnosis is one of them. MyIgSource is here to support you throughout your PI journey. Insurance & Financial Support Understanding health insurance Navigating coverage Copay assistance for eligible patients Reach out for support today. Nurse Advocates Available to answer Shire Ig products and administration questions MyIgSource.com Educational Resources & Tools Educational books, magazines, s and more about managing your PI journey 2 Patient Advocates Connect with other patients and caregivers living with PI Your guide to all things MyIgSource

5 Mike The support Mike receives from talking to his Patient Advocate helps him stay focused on making music. Julie Even PI veterans like Julie need support once in a while. Julie uses resources like the book You re Not Alone to help her family and friends understand her PI journey. Frank Frank stays informed about PI through MyIgSource s and still has time to catch his favorite football games. 3

6 Connect with Patient Advocates You are not alone. MyIgSource can connect you with other patients and caregivers living with Primary Immunodeficiency (PI). Find emotional support by talking one-on-one with these Patient Advocates who have firsthand experience with managing the daily challenges of PI. Call to talk with a Patient Advocate today. Meet Our Patient Advocates Dayna Patient Advocate and mother of four children with PI, Dayna is the Editor-in-Chief of Just Like Me Series and co-creator of the Therapeutic Play Kit. Dayna created the My IgG Book for her oldest son, Charlie. Kristin Patient Advocate Kristin is a mother of four who has experienced the pain of misdiagnosis of one of her children and the comfort that comes from speaking with other caregivers and patients. Tarsha Patient Advocate Tarsha understands the value of MyIgSource firsthand. Diagnosed with Common Variable Immune Deficiency (CVID), she took advantage of the resources and tools the program offers. Tarsha looks forward to helping other patients with their journey. Julie For Julie, a PI diagnosis didn t mean giving up an active lifestyle. In fact, shortly after being diagnosed, she participated in her first relay event to raise awareness for PI. Julie is married with a stepson and has worked as an ultrasound technician for more than 10 years. Karen Karen was diagnosed with PI in As a working mother of three adolescent children and the wife of a police officer, Karen knows a thing or two about managing a chronic illness along with everyday life. 4

7 Rhea Rhea, pronounced Ray, is the father of two young children, including a son who was diagnosed with Wiskott-Aldrich syndrome at 14 months. Rhea now seeks to help others on their journeys. Scott Scott, father of two adult children, is diagnosed with CVID. He and his wife are active in their small town community and the outdoors. Scott is thrilled to be with the Patient Advocate team and to serve with passion. Laura Laura is the mother of two active teenagers. Her son was diagnosed with CVID in PI community education and support have eased their journey, and Laura is excited to help others likewise. Kris Kris is a mother of three children with three different rare diseases. One of her daughters was diagnosed with CVID in Despite their health issues, her family has a very active lifestyle. Renee As a person diagnosed with CVID in adulthood, Renee relied on MyIgSource s tools, educational resources, and support to navigate through the uncertainty of a new diagnosis. She now wants to share with others. Sue Diagnosed with PI later in life, Sue found support from an advocate at MyIgSource. As a Patient Advocate herself now, Sue looks forward to providing educational resources and support for PI patients. Reach out for support today. Call or visit MyIgSource.com to enroll in the program. 5

8 Find Helpful Information Insurance & Financial Support Let s face it. Health insurance can be daunting or confusing, to say the least. MyIgSource can help you better understand your health insurance and the processes involved, from coverage to open enrollment to insurance changes and more. We've got PI patients covered Eligible patients on a prescribed Shire Immunoglobulin (Ig) product with commercial insurance can save up to a total of $5,000 within a 12-month period on their out-of-pocket deductible, co-payment, or coinsurance for medication costs with MyIgCoPayCard. This program provides financial support for all Shire Ig products regardless of household income. Patients are eligible for a maximum benefit of $5,000 in total Shire support within a 12-month period to help ensure that patients with PI have access to Shire Ig treatment and lessen the burden of out-of-pocket expenses for Shire Ig treatment. Not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law. Commercial insurance must cover medication costs for prescribed Shire Immune Globulin (Ig) treatment for Primary Immunodeficiency (PI) and allow for copay or co-insurance assistance. Shire reserves the right to change or discontinue this program at any time without notice. Please see full treatment-specific Terms and Conditions on product web sites for additional program restrictions and eligibility requirements or call MyIgSource for more information ( ). Nurse Advocate MyIgSource can also connect you with a nurse experienced in helping patients manage their PI and immunoglobulin treatment. She can answer questions about administration of Shire Ig treatments and help you talk to your doctor about your treatment.* Kristen BSN, RN Kristen has been a nurse advocate for MyIgSource for more than a year, and has been a registered nurse for 14 years, with 8 of those years in an outpatient infusion center where she administered Ig treatment, among other therapies. She knows how important it is for patients and their families/caregivers to be educated about the patient s condition and treatment plan. Kristen enjoys sharing her knowledge with patients and other health care providers. *Nurse Advocates cannot provide medical advice. Please contact your physician for any medical questions. Reach out for support today. Call or visit MyIgSource.com to enroll in the program. 6

9 Educational Resources & Tools Searching for accurate and credible information about PI can be time-consuming and frustrating. That s why MyIgSource offers those who have enrolled in our program the following resources, specifically designed by patients for patients, to help you better understand and manage Primary Immunodeficiency (PI). Therapeutic Play Kit This kit helps families learn how to cope with the medical environment through therapeutic play. You re Not Alone This book features 40 real patients and caregivers sharing their thoughts on the PI journey. My IgG Book Kit This kit lets children follow the story of Charlie s infusion. College Series Find out everything you wanted to know about going to college with PI, from the application process to campus life to your educational rights. Living With PI Series Receive relevant tips and information to help you on your PI journey. A Look Inside the Immune System This educational flip book provides a simplified insight into the biological structures and processes of the human immune system. The Adventures of Incredible Antibody This comic offers a fun, easy way to understand how Immune Globulin is made, from plasma collection to the lab and all the way to the patient for treatment. My Infusion Log & Wellness Calendar Stay on top of your treatment and overall wellness by logging your Ig infusions after every treatment, tracking your daily health, and communicating this information to your healthcare team. 7

10 About HYQVIA HYQVIA, the only once-a-month subq Ig 1 * For adults with Primary Immunodeficiency With HYQVIA, you have the option to infuse using 1 needle, 1 infusion site, 1 time a month, in the comfort of your own home. A second site can be used at the discretion of the physician and patient based on tolerability and total volume. HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] solution can also be administered by a healthcare professional at your doctor's office, clinic, or hospital. Work with your healthcare team to see if HYQVIA could be right for you. *SubQ Ig, also known as subcutaneous immune globulin. About HYQVIA 1 Administration Location Infused under the skin in the fatty tissues of the abdomen or thigh Infusion includes the administration of Recombinant Human Hyaluronidase prior to the administration of immune globulin Frequency Number of Sites Who Administers Where Ig is Administered Administered once a month (every 3 to 4 weeks) Dose given in 1 site A second site can be used at the discretion of the physician and patient based on tolerability and total volume Can be self-administered after patient is trained by a healthcare professional or administered by a healthcare professional Infused at home after being trained, or at a hospital or clinic Based on clinical response. After the initial ramp-up period has been completed. Indication and Usage HYQVIA is a liquid medicine containing immune globulin and Recombinant Human Hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection. Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI. 8

11 Important Safety Information about HYQVIA HYQVIA can cause blood clots. Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. Do not take HYQVIA if you are allergic to IgG, hyaluronidase, other blood products, human albumin (in the hyaluronidase solution), or have IgA deficiency with antibodies to IgA. These are not all the possible side effects with HYQVIA. Talk to your healthcare professional about any side effects that bother you or that don t go away. Please see more Safety Information on pages Please click here for FDA-approved patient labeling. HYQVIA Resource Patient Training Tools for HYQVIA Get the HYQVIA Training Kit, including a step-by-step guide, in a sling bag to make the transition to HYQVIA as simple as possible. Your doctor will determine if self-infusion of HYQVIA is appropriate for you. Do not self-infuse until you or your caregiver have received training by your doctor. To request these resources, please call MyIgSource at To learn more about HYQVIA, visit 9

12 Indication and Important Safety Information What is HYQVIA? HYQVIA is a liquid medicine containing immune globulin and Recombinant Human Hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection. HYQVIA is indicated for the treatment of Primary Immunodeficiency (PI) involving the humoral immune system in adults. Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI. HYQVIA is infused under the skin (subcutaneous). If you and your healthcare professional decide that home self-infusion of HYQVIA is right for you, then be sure you get instructions and training from your healthcare professional before using HYQVIA at home. Important Safety Information What is the most important information that I should know about HYQVIA? HYQVIA can cause blood clots. Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. Your healthcare professional may perform blood tests regularly to check your IgG level. With your consent, your healthcare professional may provide blood samples to Shire plc, to test for antibodies that may form against the hyaluronidase part of HYQVIA. Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread. Talk to your healthcare professional if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling Medical Information at Who should not take HYQVIA? Do not take HYQVIA if you: Are allergic to IgG, hyaluronidase, other blood products, or human albumin (in the hyaluronidase solution). Have IgA deficiency with antibodies to IgA. 10

13 HYQVIA can cause serious side effects. Call your healthcare professional or go to your emergency department right away if you get: Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction. Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of swelling in your brain. Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem. Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot. Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem. Chest pain or trouble breathing, blue lips or extremities. These could be signs of a lung problem. What are the possible or reasonably likely side effects of HYQVIA? After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. Mild or moderate pain, redness, swelling, or itching may occur at the site of infusion and generally go away in a few hours. Local reactions are less likely after the first few infusions. The most common side effects of HYQVIA are headache, fatigue, nausea, fever, and vomiting. Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any long term effect. In theory, these antibodies could react with your body s own PH20. PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side effects. These are not all the possible side effects with HYQVIA. Talk to your healthcare professional about any side effects that bother you or that don t go away. Before starting HYQVIA, tell your healthcare professional if you: Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse. Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products. Are pregnant, trying to become pregnant or are breast feeding. You are encouraged to report suspected side effects by contacting FDA at FDA-1088 or or Shire Drug Safety at The risk information provided here is not comprehensive. To learn more, talk about HYQVIA with your healthcare provider or pharmacist. Please click here for FDA-approved patient labeling also available at 11

14 About GAMMAGARD LIQUID Protect Life s Moments With Two Routes of Administration GAMMAGARD LIQUID is a 10% immunoglobulin replacement therapy for Primary Humoral Immunodeficiency (PI) in adults and children two years of age and older, and Ig can be infused either directly into a vein (intravenous) or just under the skin into the fatty tissue (subcutaneous). GAMMAGARD LIQUID offers a choice of intravenous (IV) and conventional subcutaneous (SubQ) administration options. 2 Talk to your healthcare provider about the treatment administration options that work best for you and your lifestyle. About GAMMAGARD LIQUID 2 Intravenous (IV) 2 Conventional Subcutaneous (SubQ) 2,3 Administration Location Infused directly into the bloodstream through a vein Infused under the skin in the fatty tissues of the abdomen, thigh, upper arm, or lower back Frequency* Once every 3-4 weeks Once a week Number of Sites One Dose can be given simultaneously in multiple sites, not to exceed 8 Who Administers A doctor, nurse, or other healthcare professional Can be self-infused after training by a healthcare professional Where Ig is Administered At a hospital or clinic or at home At home *Based on clinical response. Can also be administered by a caregiver. Please see Indication and Important Safety Information on pages and please click here for FDA-approved patient labeling. 12 To learn more about GAMMAGARD LIQUID, visit

15 GAMMAGARD LIQUID Resource Step-by-Step Guide to Self-Infusion This handy guide can help you with subcutaneous administration of GAMMAGARD LIQUID. Your doctor will determine if self-infusion of GAMMAGARD LIQUID SubQ is appropriate for you. Do not self-infuse until you or your caregiver have received training by your doctor. To request these resources, please call MyIgSource at

16 Indication and Important Safety Information What is GAMMAGARD LIQUID? GAMMAGARD LIQUID is indicated for the treatment of Primary Humoral Immunodeficiency diseases (PI) in patients two years of age and older. GAMMAGARD LIQUID is a ready-touse, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. GAMMAGARD LIQUID is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI. GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers. Although it is possible to give yourself infusions into a vein at home, they are more often given in a hospital or infusion center by a nurse. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider. Important Safety Information What is the most important information that I should know about GAMMAGARD LIQUID? GAMMAGARD LIQUID can cause the following serious reactions: Severe allergic reactions causing difficulty in breathing or skin rashes Decreased kidney function or kidney failure Blood clots in the heart, brain, lungs or elsewhere in the body Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting Dark colored urine, swelling, fatigue, or difficulty breathing Who should not use GAMMAGARD LIQUID? Do not use GAMMAGARD LIQUID if you: Have a known history of a severe allergic reaction to IgG or other blood products. Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA. GAMMAGARD LIQUID can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get: Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction. Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain. 14

17 Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem. Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot. Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem. Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem. Fever over 100 F. This could be a sign of an infection. Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications available, such as antihistamines or epinephrine. What are the possible or reasonably likely side effects of GAMMAGARD LIQUID for PI? The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions: Mild or moderate pain, swelling, itching, redness, bruising, and warmth. During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects: Headache, migraine, fever, fatigue, itching, rash/hives, cough, chest pain/ tightness, chills/shaking chills, dizziness, nausea/vomiting, faster heart rate, upper abdominal pain, increased blood pressure, muscle cramps, and sore throat. These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don t go away. You are encouraged to report suspected side effects by contacting FDA at FDA-1088 or or Shire Drug Safety at The risk information provided here is not comprehensive. To learn more, talk about GAMMAGARD LIQUID with your healthcare provider or pharmacist. Please click here for FDA-approved patient labeling also available at 15

18 About CUVITRU CUVITRU is a 20% subcutaneous immunoglobulin (SubQ Ig) replacement therapy for Primary Humoral Immunodeficiency (PI) in adults and children 2 years of age and older. 3 With CUVITRU, the dose is given in up to 4 sites simultaneously at the discretion of the physician and patient based on tolerability and total volume. Patients can self-infuse* CUVITRU at regular intervals from daily up to every 2 weeks (biweekly) after receiving training from a healthcare professional. 3 About CUVITRU 3 Administration Location Infused under the skin in the fatty tissues of the upper arms, abdomen, thighs, or lower back Frequency Administered at regular intervals from daily up to every 2 weeks Number of Sites Who Administers Where Ig Is Administered Dose given in up to 4 sites simultaneously at the discretion of the physician and patient based on tolerability and total volume Can be self-administered* after patient is trained by a healthcare professional Infused in the home or other appropriate setting *Can also be administered by a caregiver. Based on clinical response. Please see Indication and Important Safety Information on pages and please click here for FDA-approved patient labeling. 16 To learn more about CUVITRU, visit

19 CUVITRU Resources Patient Training Tools for CUVITRU The CUVITRU Training kit has a variety of tools and resources that help make the transition to CUVITRU as simple as possible. The ABCs to Infuse CUVITRU The CUVITRU Infusion Guide provides step-by-step instructions for patients to reference before, during and after treatment. Your doctor will determine if self-infusion of CUVITRU is appropriate for you. Do not self-infuse until you or your caregiver have received training by your doctor. To request these resources, please call MyIgSource at

20 Indication and Important Safety Information What is CUVITRU? CUVITRU is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. CUVITRU is indicated for the treatment of Primary Humoral Immunodeficiency (PI) in adult and pediatric patients two years of age and older. CUVITRU is made from human plasma that is donated by healthy people. CUVITRU contains antibodies collected from these healthy people that replace the missing antibodies in PI patients. CUVITRU is given under the skin (subcutaneously). Most of the time infusions under the skin are given at home by self infusion or by caregivers. Only use CUVITRU by yourself after you have been instructed by your healthcare provider. Important Safety Information What is the most important information that I should know about CUVITRU? CUVITRU can cause the following serious reactions: Severe allergic reactions causing difficulty in breathing or skin rashes Decreased kidney function or kidney failure Blood clots in the heart, brain, lungs, or elsewhere in the body Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting Dark colored urine, swelling, fatigue, or difficulty breathing Who should not use CUVITRU? Do not use CUVITRU if you: Are allergic to immune globulin or other blood products. Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA. 18

21 CUVITRU can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get: Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction. Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain. Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem. Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot. Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem. Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem. Fever over 100 F. This could be sign of an infection. What are the possible or reasonably likely side effects of CUVITRU? The following one or more possible side effects may occur at the site of infusion: mild or moderate pain, redness, and itching. These generally go away within a few hours, and are less likely after the first few infusions. The most common side effects that may occur are: headache, nausea, fatigue, diarrhea, and vomiting. These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don t go away. You are encouraged to report suspected side effects by contacting FDA at FDA-1088 or or Shire Drug Safety at The risk information provided here is not comprehensive. Please click here for FDA-approved patient labeling also available at References: 1. HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 3. CUVITRU [Immune Globulin Subcutaneous (Human)] 20% [Prescribing Information]. Westlake Village, CA. Baxalta US Inc. 19

22 MyIgSource can help at diagnosis and throughout your PI journey. Insurance & Financial Support Enroll Today! Nurse Advocates MyIgSource.com Patient Advocates Educational Resources & Tools MyIgSource is open to all Primary Immunodeficiency (PI) patients and caregivers regardless of treatment. Please see Indication and Important Safety Information on pages 10-11, 14-15, and and please see FDA-approved patient labeling by clicking here for HYQVIA, GAMMAGARD LIQUID, and CUVITRU Shire US Inc., Lexington, MA All rights reserved SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. Cuvitru, Gammagard, Gammagard Liquid, Hyqvia, Igi, and MyIgSource are registered trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc. S /17