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Shire Immunoglobulin Treatments

When it comes to treating primary immunodeficiency (PI), we know you have options. And only you and your doctor can decide which treatment is best for you.

If you and your doctor have decided that you should be treated with an immunoglobulin (Ig), Shire offers a few different ways you can receive your Ig treatment, as shown in the following chart:

Shire Ig Treatments

Indicated for adult patients with primary immunodeficiency

Subcutaneous (SubQ)1

  • Infused under the skin in the fatty tissues of the abdomen or thighs
    Infusion includes the administration of Recombinant Human Hyaluronidase prior to the administration of immune globulin
  • 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 being trained by a healthcare professional or administered by a healthcare professional
  • Infused at home after being trained, or at a hospital or clinic
Learn More

Indicated for patients two years of age and older with primary immunodeficiency

Intravenous (IV)2

  • Infused directly into the bloodstream through a vein
  • Administered once every 3 to 4 weeks
  • Dose given in 1 site
  • Administration requires a healthcare professional
  • Infused at hospital, clinic, or home with nurse present
Learn More

Conventional SubQ2

  • Infused under the skin in the fatty tissues of the abdomen, thighs, upper arms, or lower back
  • Administered once a week
  • Dose given in multiple sites
    The number of simultaneous sites should be limited to 8
  • Can be self-administered after patient is trained by a healthcare professional
  • Infused at home after being trained
Learn More

Indicated for patients 2 years of age and older with primary immunodeficiency

Conventional SubQ3

  • Infused under the skin in the fatty tissues of the upper arms, abdomen, thighs, or lower back
  • Administered at regular intervals from daily up to every 2 weeks
  • Dose given in up to 4 sites simultaneously based on 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 at home after being trained, or in another appropriate setting
Learn More

Based on clinical response
Can also be administered by a caregiver

GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA < 1 μg/mL in a 5% solution4

For those who need an IgG with a low level of the type of Ig called IgA, this intravenous treatment may be an option.

GAMMAGARD S/D

More Details

We've got eligible patients with Primary Immunodeficiency (PI) covered!

Learn more about the MyIgCopayCard Program here.

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Detailed Important Safety Information

Please read below for the Indication and Detailed Important Safety Information for HYQVIA, GAMMAGARD LIQUID, GAMMAGARD S/D, 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 for GAMMAGARD S/D, 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.

GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 microgram per mL in a 5% Solution

What is GAMMAGARD S/D?

  • GAMMAGARD S/D is a freeze-dried medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. GAMMAGARD S/D is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with primary immunodeficiency (PI). GAMMAGARD S/D is given into a vein (intravenously).
  • GAMMAGARD S/D is indicated for the treatment of PI in patients two years of age and older.
  • GAMMAGARD S/D is indicated for the prevention of bacterial infections in patients with low levels of IgG antibodies or recurrent infections associated with B-cell Chronic Lymphocytic Leukemia.
  • GAMMAGARD S/D is indicated for the treatment of adult chronic Idiopathic Thrombocytopenic Purpura patients to increase platelet count and to prevent and/or control bleeding.
  • GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.

Do not use GAMMAGARD S/D if you:

  • Have a known history of a severe allergic reaction to IgG or other blood products.
  • Have a known history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with <1 μg/mL IgA in a 5% solution

Before starting GAMMAGARD S/D, tell your healthcare professional if you:

  • Have history of thrombosis (blood clots), thrombotic events, poor kidney function or kidney failure
  • Are on a low sodium diet
  • Are sensitive to rubber latex

What is the most important information that I should know about GAMMAGARD S/D?

  • GAMMAGARD S/D can cause blood clots. Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of your body.
  • Kidney problems can occur in patient receiving intravenous IgG. Symptoms of a kidney problem may include: reduced urination, sudden weight gain or swelling in your legs.

GAMMAGARD S/D can cause other 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.
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
  • 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.

What are the possible or reasonably likely side effects of GAMMAGARD S/D?

The most common side effects of GAMMAGARD S/D are headache, nausea, chills, fatigue, fever, upper abdominal pain, diarrhea, back pain, infusion site pain, sweating, and flushing.

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 S/D with your healthcare provider or pharmacist. The FDA-approved patient product labeling can be accessed by clicking here.

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.

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.
  4. GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 μg/mL in a 5% Solution [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.