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Questions? Call 1-855-250-5111.

Shire Primary Immunodeficiency patient brochure

Support for You
& Your Patients

We know the challenges that can come with starting a new treatment and living with a chronic disease like primary immunodeficiency (PI).

That's why we created MyIgSource, with support and resources—for both you and your patients—to help at diagnosis, the start of immunoglobulin (Ig) treatment, and beyond.

Start using MyIgSource today call 1-855-250-5111.

Get Patients Started

Download the Shire Ig products prescription referral form.

How MyIgSource Supports Your Patients

  • Insurance Support

    Coverage Assistance with benefits verification, prior authorization questions

    Reimbursement Resources for billing and coding questions

    CoPay Assistance Available to eligible PI patients

  • Nurse Support

    Nurse Advocates Available via phone to answer administration questions about Shire Immunoglobulin (Ig) treatments

    Administration Administration training for Shire products

  • Patient Support

    Patient Advocates Available via phone, all are PI patients or caregivers

    PI Support Emotional support, resources and tools Download the Patient Brochure

Insurance Support for Healthcare Professionals

MyIgSource is designed to assist patients, caregivers, and healthcare providers in navigating insurance, connecting to nurse and patient advocates, and accessing educational resources and tools.

MyIgSource Insurance Support provides access to coverage and reimbursement by providing support with benefit verifications and prior authorizations, and resources for billing, coding, and more for Shire Immunoglobulin (Ig) treatments for PI.*

For more information, call MyIgSource Insurance Support directly at 1-855-217-1615.

*With a valid prescription for Shire products

What MyIgSource case managers will do:
  • Complete patient- and product-specific benefit verifications*:
    • Confirm your patients' specific insurance benefits and coverage options
    • Return patient-specific benefit information to you typically within 1 business day
  • If prior authorization is required:
    • Obtain insurance company specific requirements and forms
    • Pre-populate non-clinical patient demographic information
    • Follow up with the insurance company to obtain approval or denial
  • If your prior authorization is denied:
    • Obtain reason for denial
    • Determine if an appeal is available
    • Provide supporting resources such as key contact information, checklists, best practices, and templates
  • Connect you to a Shire Reimbursement Manager who can provide specialized billing and coding assistance while you continue to work through the approval process
  • If the first appeal is denied:

    Connect you to a nurse for Tier 2 appeal support and patient-specific Letter of Medical Necessity (LMN) support

  • Once coverage is approved, the information will be triaged to either:
    • Your preferred infusion provider, OR
    • Your office
  • If Shire MyIgCoPayCard program is available, coordinate with infusion providers and patient advocates to faciliate the MyIgCoPayCard enrollment process.

*With a valid prescription for Shire products

Shire Financial Support

Shire is dedicated to helping patients with Primary Immunodeficiency start or transition to Shire Ig treatments.

Shire offers copay assistance for Shire Ig products to eligible patients with PI. To learn more, call MyIgSource today at 1-855-250-5111.

Specialty Pharmacy Program (SPP) Support for Nurses

SPP Nurses can contact a Nurse Advocate at MyIgSource for Shire Ig treatment administration questions. The Nurse Advocates are available 8:30-5:30 EST Monday-Friday, to offer support before, during or after infusions.

Want more details? Download the Patient Brochure here

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Detailed Important Safety Information

Please read below for the Indication and Detailed Important Safety Information for HYQVIA, GAMMAGARD LIQUID, AND CUVITRU.

Please see Full Prescribing Information and Patient Product Information for HYQVIA, including Boxed Warning; Full Prescribing Information and Patient Product Information for GAMMAGARD LIQUID, including Boxed Warning; and Full Prescribing Information and Patient Product Information for CUVITRU, including Boxed Warning.

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, or 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 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 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.

Please see the FDA Approved Patient Labeling.

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.

Please see the FDA-Approved Patient Product Labeling.

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 Risk 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 100ºF. 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 found accessed by clicking here.

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