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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.

Shire offers a few different ways you can receive your Ig treatment, as shown in the following chart:

Shire Ig Treatments

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution
For adults with primary immunodeficiency (PI)
IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about HYQVIA?

  • HYQVIA can cause blood clots
  • Call your healthcare professional (HCP) 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 HCP may perform blood tests regularly to check your IgG level.
  • With your consent, your HCP 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 HCP if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.
Click for additional Important Safety Information and Information For Patients for HYQVIA, and discuss with your HCP.
Subcutaneous (SubQ) 1
Infused under the skin in the fatty tissues of the abdomen or thighs

Infusion includes the SubQ 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 healthcare professional based on tolerability and total volume
Can be self-administered after patient or caregiver is trained by a healthcare professional
Infused at a hospital, clinic, or healthcare professional's office, or at home after being trained
GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%
For people 2 years and older with primary immunodeficiency (PI)
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
Click for additional Important Safety Information and Information For Patients for GAMMAGARD LIQUID, and discuss with your HCP.
Intravenous (IV)2
Infused directly into the bloodstream through a vein
Administered once every 3 to 4 weeks
Dose given in 1 site
Most often administration is performed by a healthcare professional
Infused at hospital, clinic, or home with a nurse present
GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%
Indicated for patients two years of age and older with primary immunodeficiency
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 or caregiver is trained by a healthcare professional
Infused at a hospital, clinic, or healthcare professional's office, or at home after being trained
CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution
For people 2 years and older with primary immunodeficiency (PI)
IMPORTANT SAFETY INFORMATION

What is the most important information I need to 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
Click for additional Important Safety Information and Information For Patients For Patients for CUVITRU, and discuss with your HCP.
Conventional SubQ3
Infused under the skin in the fatty tissues of the abdomen, thighs, upper arms, or lateral hip
Administered at regular intervals from daily up to every 2 weeks
Dose given in up to 4 sites simultaneously based on the direction of the healthcare professional based on tolerability and total volume
Can be self-administered after patient or caregiver is trained by a healthcare professional
Infused at a hospital, clinic, or healthcare professional's office, or at home after being trained

*Based on clinical response

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

GAMMAGARD S/D is a medicine that is given in a vein (intravenously) by a healthcare professional to treat primary immunodeficiency (PI) in people 2 years and older. It may be an option for people who need an Ig treatment with low levels of the type of Ig call IgA.

IMPORTANT SAFETY INFORMATION

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

GAMMAGARD S/D can cause the following serious reactions:

  • Serious 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

Click for additional Important Safety Information and Information For Patients for GAMMAGARD S/D, and discuss with your HCP.

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

Learn more about the MyIgCopayCard Program here.

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IMPORTANT SAFETY INFORMATION

Please expand for Indications and Important Safety Information.

What is the most important information that I should know about CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D 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

What are CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D are medicines used to treat primary immunodeficiency (PI).

CUVITRU is for people 2 years and older and given under the skin (subcutaneously).

HYQVIA is for adults and given under the skin.

GAMMAGARD LIQUID is for people 2 years and older and given in a vein (intravenously) or under the skin.

GAMMAGARD S/D is for people 2 years and older and given in a vein.


IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D 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

Additionally for HYQVIA:

  • Call your healthcare professional (HCP) 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 HCP may perform blood tests regularly to check your IgG level.
  • With your consent, your HCP 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 HCP if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724

Who should not use CUVITRU, HYQVIA, GAMMAGARD LIQUID, or GAMMAGARD S/D?

  • Do not use CUVITRU or GAMMAGARD LIQUID if you have had a severe allergic reaction to immune globulin or other blood products, or have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.
  • Do not take HYQVIA if you are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.
  • Do not use GAMMAGARD S/D if you have had a severe allergic reaction to GAMMAGARD S/D.

What should I avoid while taking CUVITRU, HYQVIA, GAMMAGARD LIQUID, or GAMMAGARD S/D?
What should I tell my HCP before I start using CUVITRU, HYQVIA, GAMMAGARD LIQUID, or GAMMAGARD S/D?

  • CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your HCP that you take any of these treatments.
  • Tell your HCP if you are pregnant, trying to become pregnant, or nursing.
  • Before starting HYQVIA, tell your HCP 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.

What are the possible or reasonably likely side effects of CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D can cause serious side effects. If any of the following problems occur after starting any of these treatments, stop the infusion immediately and contact your HCP or call emergency services:

  • 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 and swelling 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.
  • Fever over 100°F. This could be a sign of an infection.

For CUVITRU, the following one or more possible side effects 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
  • Redness
  • Itching

The most common side effects of CUVITRU are:

  • Headache
  • Nausea
  • Fatigue
  • Diarrhea
  • Vomiting

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. The following possible side effects may occur at the site of infusion and generally go away within a few hours, and are less likely after the first few infusions:

  • Mild or moderate pain
  • Redness
  • Swelling
  • Itching

The most common side effects of HYQVIA are:

  • Headache
  • Fatigue
  • Nausea
  • Fever
  • Vomiting

The following one or more possible reactions may occur at the site of infusion of GAMMAGARD LIQUID for PI, generally go away within a few hours, and are less likely after the first few infusions:

  • Mild or moderate pain
  • Swelling
  • Itching
  • Redness
  • Bruising
  • Warmth

During the infusion of GAMMAGARD LIQUID for PI, 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
  • Sore throat

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
  • Flushing

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

For additional safety information click for Information For Patients for CUVITRU, HYQVIA, GAMMAGARD LIQUID and GAMMAGARD S/D, and discuss with your HCP

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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.