What is GAMMAGARD LIQUID?
GAMMAGARD LIQUID is the first and only FDA-approved intravenous immunoglobulin (IVIG) for adults with Multifocal Motor Neuropathy (MMN).
IVIG for MMN is the standard treatment.
GAMMAGARD LIQUID is the only IVIG in clinical trials shown to improve grip strength and reduce disability in MMN*
GAMMAGARD LIQUID is an antibody therapy that contains immunoglobulin G (IgG). The term Ig means antibodies, like the ones you have in your immune system to fight infections. However, with MMN, your body's immune system may mistakenly attack your motor nerves. Ig therapy infuses a specific type of antibody into your body to support a healthy immune system. Your doctor might also refer to GAMMAGARD LIQUID as an Ig treatment, intravenous Ig or IVIG.
*In a 60-week clinical study with 44 adults with MMN, GAMMAGARD LIQUID was shown to improve or maintain grip strength and reduce disability compared to placebo.
GAMMAGARD LIQUID is made from plasma donations
How does human plasma become this unique IVIG? Watch this introduction to how GAMMAGARD LIQUID is made.
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.
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.
Pretty cool, huh?
But do you know how these therapies are made?
Let me show you.
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.
It begins with donor selection.
Potential donors are strictly screened before their plasma is collected and their donation is tested for viruses and infections.
Then, experts carefully remove the IgG antibodies that are needed to create the final product.
After this, they purify the IgG antibodies in several stages.
And, while donor screening and donation testing minimize the chances of viruses, three specialized steps clear any viruses that may still be there.
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.
Looking good!
After a final inspection, GAMMAGARD LIQUID is shipped to the people it’s prescribed to.
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 100ºF. This could be a sign of an infection.
TThe 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 CIDP include:
Headache, chest discomfort, muscle spasms, muscular weakness, nausea, sore throat, ear pain, pain in hands or feet.
These are not all the possible side effects. Talk to your HCP about any side effects that bother 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 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.
GAMMAGARD LIQUID is supported by a strong legacy of more than 60 years of experience in IgG therapies. IgG is derived from plasma, which is part of human blood. Every step of the process used to make GAMMAGARD LIQUID ensures that your therapy is reliable and meets high safety standards.
3 steps to meet high safety standards
The plasma that’s used to make GAMMAGARD LIQUID goes through a rigorous process to get rid of viruses that could have potentially been included during the collection.
STEP 1. Virus reduction
The plasma is treated with a solution that inactivates viruses within minutes
STEP 2. Virus removal
The plasma goes through a filter process to remove small germs by size
STEP 3. Virus inactivation
The plasma is kept in special conditions to further inactivate viruses
Why are plasma donors needed?
They can save lives. For many rare diseases, including MMN, immunoglobulin is an important treatment available—and it can’t be made without plasma donations. Learn more and find a donor center near you.
If a BioLife Center is not in your area, you can also donate through the American Red Cross.
Made with your needs in mind
Are you watching your sugar intake? How about extra sodium? You might be interested to know that GAMMAGARD LIQUID may meet the needs of people who have special considerations.
Not all IVIGs are the same. GAMMAGARD LIQUID has:
no added sugars
no added
sodium
no added
preservatives
no sucrose
Latex allergy? No worries. GAMMAGARD LIQUID packaging is not made with natural rubber latex.
GAMMAGARD LIQUID is also stabilized and buffered with glycine.
Ready to talk with your doctor?
Your experience with MMN is personal, so this discussion guide is all about you. We’ll ask questions to help you have a discussion with your doctor about where you are now—so you can start working toward where you want to be.
