PI Patient Training Kit
For Subcutaneous (SubQ) Administration of GAMMAGARD LIQUID for Primary Immunodeficiency
Find out what you need to know about SubQ administration.This kit includes:
- A training DVD on SubQ for patients and caregivers
- A binder with step-by-step instructions on SubQ administration and tips for managing the infusion
- A handy infusion mat to guide you in setting up for your infusion
Approved for adult patients with MMN
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disease that causes
GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%
GAMMAGARD LIQUID is used to treat patients with primary immunodeficiency diseases (PI). There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. GAMMAGARD LIQUID is made from human plasma that is donated by healthy people. GAMMAGARD LIQUID contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.
GAMMAGARD LIQUID is also used to treat patients with Multifocal Motor Neuropathy (MMN), a rare disease that causes muscle weakness that worsens over time. It affects the strength of the lower parts of arms and hands more than the legs, usually without affecting the touch sensation.
Detailed Important Risk Information for Patients
Tell your healthcare provider about any side effect that bothers you or that does not go away.
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
Tell your healthcare provider if you have a history of poor kidney function or kidney failure. If so, GAMMAGARD LIQUID should be administered at the slowest intravenous infusion rate as determined by your healthcare provider.
Contact your healthcare provider or call emergency services immediately if you have reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
Do not use GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if GAMMAGARD LIQUID can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.
If any of the following problems occur after starting treatment with GAMMAGARD LIQUID, stop the infusion immediately and contact your healthcare provider or call emergency services.
These could be signs of a serious problem:
- 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 problem or a blood problem.
- Chest pain or trouble breathing, 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.
These are not all of the possible side effects with GAMMAGARD LIQUID. You can ask your healthcare provider for the physician’s information leaflet. Tell your healthcare provider about any side effect that bothers you or that does not go away.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting viruses and theoretically vCJD agent. Patients should report to their healthcare provider any symptoms that concern them which might be caused by virus infections.
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
During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects:
- Chest pain/tightness
- Chills/Shaking chills
- Faster Heart Rate
- Upper Abdominal Pain
- Increased Blood Pressure
- Muscle cramps
- Sore throat
Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help should a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.
Please see the GAMMAGARD LIQUID Full Prescribing Information.
If you would like to report an adverse reaction, contact Baxter Global Pharmacovigilance: 1-866-888-2472
If you have a medical/clinical question regarding the use of GAMMAGARD PRODUCTS, contact Baxter Medical Information:
1-866-424-6724 or email@example.com
- GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA. Baxter Healthcare Corporation.
- Data on file, Baxter International Inc. 2011
- Sharrack B, Hughes RAC. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999;5(4):223-233.