GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

What Is IG?

What is IG therapy?

Within the human body there are many types of antibodies made by the immune system. The immune globulin (IG) antibodies help fight off bacteria and viruses that cause infections. IG therapy contains antibodies from healthy donations of human plasma, which is the fluid portion of the blood that is left when blood cells are removed.

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 is made

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

GAMMAGARD LIQUID is indicated as a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older, as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN), and as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Thrombosis, Renal Dysfunction, and Acute renal Failure are Boxed Warnings for GAMMAGARD LIQUID.

Please see additional Important Safety Information in this video, and the accompanying Full Prescribing Information.

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 effects of GAMMAGARD LIQUID for CIDP include:

  • Headache
  • Fever
  • Anemia
  • Illness
  • Dizziness
  • Migraine
  • Somnolence
  • Tremor
  • Nasal dryness
  • Upper abdominal pain
  • Vomiting
  • Chills
  • Nasopharyngitis
  • Pain in extremity

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.