Living with PI can be tough, Shire is here to help with a 30-year legacy of supporting people living with PI2

Facing the challenges of living with PI can be difficult, but you’re not alone. Here you’ll find resources to help you manage life with PI and your treatment with CUVITRU [Immune Globulin Subcutaneous (Human)] 20%.

You should always ask your doctor when you have questions about your medicine, but for general information about copay assistance and insurance, emotional support, and resources to help you with administration, see below.

CoPay Assistance

We’ve got PI patients covered

For eligible PI patients with commercial insurance, the MyIgCoPayCard can help cover your medication costs for CUVITRU.

With the MyIgCoPayCard, you’ll:

infusion sites iconGet help accessing Shire Ig treatments
infusion vol iconLessen the burden of out-of-pocket expenses for Shire Ig treatment

Eligible patients with PI on a prescribed Shire Immune Globulin (Ig) treatment with commercial insurance can save up to a total of $5000* over 12 months on their out-of-pocket, co-payment, co-insurance, or deductible for medication costs with the MyIgCoPayCard. This program provides financial support for all Shire Ig treatments, regardless of household income.

myigsource
  • *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 coinsurance 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 websites for additional program restrictions and eligibility requirements or call MyIgSource for more information (1-855-250-5111).

MyIgSource

MyIgSource is here to provide support when you need it

Life is full of beginnings, and a primary immunodeficiency (PI) diagnosis is one of them. MyIgSource is a program designed to support you at diagnosis and throughout your PI journey. You'll find insurance and financial support, emotional and Shire Ig treatment-related support, and resources and tools to help you manage PI.

Reach out for support today.

Call 1-855-250-5111 or visit MyIgSource.com to enroll in the program. This program is available to all PI patients and caregivers, regardless of treatment.

infusion sites iconInsurance and Financial Support

Get help understanding health insurance, navigating coverage, and identifying copay assistance options for your Shire treatment.

infusion vol iconEducational Resources and Tools

Access educational books, magazines, emails, and more about managing your PI journey.

infusion sites iconPatient Advocates

Connect with other patients and caregivers living with PI. Your Patient Advocate will also be your guide to all things MyIgSource.

infusion vol iconNurse Advocates

Experienced nurses are available to answer your Shire Ig product and administration questions. Nurse Advocates cannot provide medical advice. For medical advice, please contact your physician.

infusion sites iconPatient Advocates

Connect with other patients and caregivers living with PI. Your Patient Advocate will also be your guide to all things MyIgSource.

infusion vol iconEducational Resources and Tools

Access educational books, magazines, emails, and more about managing your PI journey.

infusion vol iconNurse Advocates

Experienced nurses are available to answer your Shire Ig product and administration questions. Nurse Advocates cannot provide medical advice. For medical advice, please contact your physician.

myigsourcevideo

Visit the MyIgSource YouTube ChannelHear from MyIgSource Patient Advocates on YouTube about living with PI. Watch Now >

Resources for Managing PI

You’re in charge, and Shire’s here to help

Below are some resources to help you find your own path to living better with PI.

PI Organizations

Professional Organizations

For more information about CUVITRU [Immune Globulin Subcutaneous (Human)] 20%, sign up >

To learn more about managing PI, visit:

MyIgSource.com >

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Please expand for Indication and Important Safety Information.

Important Safety Information About CUVITRU

CUVITRU can cause blood clots in the heart, brain, lung, and elsewhere in the body. Call your healthcare professional or go to your emergency department right away if you have pain, swelling, warmth, redness, a lump in your legs or arms, chest pain, trouble breathing, or blue lips or extremities. These could be signs of a blood clot.

Do not take CUVITRU if you are allergic to immune globulin or other blood products, or have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.

Indication and Important Safety Information CUVITRU [Immune Globulin Subcutaneous (Human)], 20% Solution

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.

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 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about CUVITRU with your healthcare provider or pharmacist. The FDA-approved product labeling can be accessed by clicking here.

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution

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-to-use, 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.
  • 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 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about GAMMAGARD LIQUID with your healthcare provider or pharmacist. The FDA-approved patient product labeling can be accessed by clicking here.

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution

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 1-866-424-6724.

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.

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 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, 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, or blue lips or extremities. These could be signs of a serious heart or 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 1-800-FDA-1088 or www.fda.gov/medwatch or Shire Drug Safety at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about HYQVIA with your healthcare provider or pharmacist. The FDA-approved patient labeling can be accessed by clicking here.

GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA < 1 µG/mL in a 5% Solution

Indication and Usage

GAMMAGARD S/D is an immune globulin indicated as replacement therapy for primary humoral immunodeficiency (PI) for adult and pediatric patients 2 years and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic ITP to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.

GAMMAGARD S/D is for intravenous use only.

Important Safety Information

BOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin products, including GAMMAGARD S/D. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products, including GAMMAGARD S/D. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD S/D does not contain sucrose.
  • For patients at risk of thrombosis, administer GAMMAGARD S/D at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Contraindications

  • GAMMAGARD S/D is contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with < 1 µg/mL IgA in a 5% solution.

Warnings and Precautions

  • Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
  • Renal Dysfunction/Failure: Monitor renal function and urine output. For patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or with predisposition to acute renal failure, use the minimum infusion rate practicable for IV administration of GAMMAGARD S/D.
  • Thrombosis: Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity.
  • Aseptic Meningitis Syndrome (AMS): Monitor for clinical signs and symptoms of AMS.
  • Hemolysis: Monitor for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.
  • Transfusion-Related Acute Lung Injury (TRALI): Monitor for pulmonary adverse reactions associated with TRALI.
  • Transmittable Infectious Agents: Because the Immune Globulin Infusion (Human) is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses and other pathogens. No cases of transmission of viral diseases or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD S/D.
  • Hyperproteinemia, increased serum viscosity, and alterations in serum sodium levels may occur.
  • Interference with Laboratory Tests: False positive serological test results, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

ADVERSE REACTIONS

The most common adverse reactions observed in = 5% of clinical trial patients during or within 48 hours of infusion were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis and flushing.

Serious adverse reactions reported postmarketing were anaphylaxis, acute renal failure, myocardial infarction, cerebrovascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism, aseptic meningitis, acute hemolysis and TRALI.

Please see Full Prescribing Information, including Boxed Warning regarding Thrombosis, Renal Dysfunction and Acute Renal Failure, by clicking here.

References: 1. CUVITRU [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. U.S. Food and Drug Administration. User fee billable biologic products and potencies approved under section 351 of the PHS Act. 3. Suez D, Stein M, Gupta S, et al. Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36(7):700-712. 4. Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patient with primary immunodeficiency disease. Clin Exp Immunol. 2015; 179(2):146-160. 5. Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Disease. 5th ed. Towson, MD: Immune Deficiency Foundation;2013.6. Bousfiha A, Jeddane L, Al-Herz W, et al. The 2015 IUIS phenotypic classification for primary immunodeficiencies. J Clin Immunol. 2015;35(8):727-738. Doi:10.1007/s10875-015-01985. Epub October 7, 2015. 7. Immune Deficiency Foundation. Primary Immunodeficiency Disease in America: 2007.
The Third National Survey of Patients
. Prepared by Abt. SRBI, Inc. May 1, 2009.8. Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol. 2007;27(5):497-502.9. Modell F, Puente D, Modell V. From genotype to phenotype. Further studies measuring the impact of a Physician Education and Public Awareness Campaign on early diagnosis and management of primary immunodeficiencies. Immunol Res. 2009;44(1-3):132-149. 10. GAMMAGARD LIQUID [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 11. HYQVIA [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.12. GAMMAGARD S/D [Prescribing Information] Westlake Village, CA: Baxalta US Inc. 13. 10 Warning Signs of Primary Immunology: Jeffrey Modell Foundation; 2016.14. Gelfand EF. Differences between IGIV products: Impact on clinical outcome. International Immunopharmacology. 2006;6:592-599.

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