Maybe you know all about PI, maybe you know a little.

PI=primary immunodeficiency.

Regardless of how much you know, this page covers off on some important basics to help you be more knowledgeable.

What is PI?

PI is a term used to describe a group of disorders that cause the immune system to not work correctly.

The immune system protects your body from germs, like bacteria and viruses. When the immune system doesn’t work the way it’s supposed to, you’re more likely to: 

  • get infections more often
  • get more serious infections
  • take longer to get better

Although PI was once considered rare, more people are getting diagnosed because doctors are more aware of what to look out for.

How do you know if you have PI?

Your doctor will do PI testing. PI can sometimes be difficult to diagnose, so make sure to have honest, open conversations with your doctor(s), ask questions, and talk about any symptoms you may be experiencing.

How is PI treated?

The most common way to treat PI is with immune globulin, or IG. IG contains antibodies that help your body fight infections.

1 in 1,200

people are thought to be affected by PI

250,000

Americans are estimated to have been diagnosed with PI

500,000

more Americans are suspected to have PI but haven’t been diagnosed yet

PI=primary immunodeficiency.

Where do the antibodies I need come from?

Antibodies come from plasma, which is part of human blood that comes from healthy people. Every donation is carefully tested, and each step of the process used to make GAMMAGARD LIQUID ensures that your therapy is reliable and meets high safety standards.  

We meet high safety standards in 3 steps.

The plasma that’s used to make GAMMAGARD LIQUID goes through a rigorous process of reduction, removal, and inactivation to get rid of viruses that might have been included during the collection.

Check out this video to learn more about how GAMMAGARD LIQUID is made:

Narrator: Before we get started, let’s go through some Important Safety Information.

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older, given in a vein to treat multifocal motor neuropathy (MMN) in adults, and given in a vein to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Before starting treatment with GAMMAGARD LIQUID, talk to your doctor about possible side effects.

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.

Please see additional Important Safety Information in this video, and the accompanying Information for Patients, and discuss with your Healthcare Provider.

Narrator: Want to see one of the world’s most precious assets? No, it's not a diamond, it's not gold. This is human plasma, and it’s used to create immunoglobulin therapies, like GAMMAGARD LIQUID.

Narrator: Pretty cool, huh? But do you know how these therapies are made? Let me show you.

Narrator: Precious things need to be handled with care. And this is no exception. It’s not a process that can be rushed. No, no. It’s a journey of dedication and care. The process takes up to a year and follows rigorous quality and safety measures.

Narrator: It begins with donor selection. Potential donors are strictly screened before their plasma is collected and their donation is tested for viruses and infections.

Narrator: Then, experts carefully remove the IgG antibodies that are needed to create the final product.

Narrator: After this, they purify the IgG antibodies in several stages.

Narrator: And while donor screening and donation testing minimize the chances of viruses, three specialized steps clear any viruses that may still be there.

Narrator: Immunoglobulin therapies are all produced in a similar way. But their features are different. GAMMAGARD LIQUID is designed with patient needs in mind. Its specific characteristics make it suitable for a broad range of patients. For example, it doesn’t contain any added sugar or sodium, which may be important things to consider for patients who are watching their salt and sugar intake.

Narrator: Looking good!

Narrator: After a final inspection, GAMMAGARD LIQUID is shipped to the people it’s prescribed to.

Narrator: People like me!

What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older, given in a vein to treat multifocal motor neuropathy (MMN) in adults, and given in a vein to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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 had a severe allergic reaction to immune globulin or other blood products.
  • Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking GAMMAGARD LIQUID?

  • GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take GAMMAGARD LIQUID.
  • Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause serious side effects. If any of the following problems occur after starting GAMMAGARD LIQUID, 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. 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.

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
  • Rashes/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 LIQUID for MMN include:

  • Headache
  • Chest discomfort
  • Muscle spams
  • Muscular weakness
  • Nausea
  • Sore throat
  • Ear pain
  • Pain in hands or feet

The most common side effect of GAMMAGARD LIQUID for CIDP includes:

  • Headache

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, including Warning about Blood Clots, Decreased Kidney Function, and Kidney Failure, see accompanying Information For Patients on the GAMMAGARD LIQUID website www.gammagard.com, and discuss with your healthcare provider.

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

IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots, decreased kidney function or kidney failure

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.

INDICATION

What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

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 had a severe allergic reaction to immune globulin or other blood products.
  • Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking GAMMAGARD LIQUID?

  • GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take GAMMAGARD LIQUID.
  • Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause serious side effects. If any of the following problems occur after starting GAMMAGARD LIQUID, 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. 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.

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
  • Rashes/hives
  • Cough
  • Chest pain/tightness
  • Chills/shaking chills
  • Dizziness
  • Nausea/vomiting
  • Faster heart rate
  • Upper abdominal pain
  • Increased blood pressure
  • Muscle cramps
  • Sore throat

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 including Warning about Blood Clots, Decreased Kidney Function, and Kidney Failure, click for Information for Patients and discuss with your HCP.

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