GAMMAGARD LIQUID is used to treat patients two years of age and older with primary immunodeficiency diseases (PI). There are many forms of PI. GAMMAGARD LIQUID contains antibodies collected from healthy people that replace the missing antibodies in PI patients.

GAMMAGARD LIQUID is also used to treat adult patients with Multifocal Motor Neuropathy (MMN), a rare disease that causes muscle weakness that worsens over time.

Stop the infusion immediately and contact your healthcare provider or call emergency services if you have any of the following:

Symptoms of thrombosis (blood clots) that may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration (redness) or lump in an arm or leg, 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.

Symptoms of a kidney problem that may include: reduced urination, sudden weight gain or swelling in your legs.

Symptoms of a serious allergic reaction that may include: hives, skin rash, itching, swelling in the mouth or throat, trouble breathing, wheezing, fainting or dizziness.

Other serious symptoms including: bad headache with nausea, vomiting, stiff neck, drowsiness, fever, sensitivity to light, painful eye movements; brown or red urine, fast heart rate, yellow skin or eyes; trouble breathing, blue lips or extremities; fever over 100°F.

Tell your healthcare provider if you have a history of thrombosis (blood clots), thrombotic events, poor kidney function or kidney failure.

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 deficiency.

GAMMAGARD LIQUID is made from human plasma. It may contain infectious agents that can cause disease e.g., viruses, and theoretically, the Creutzfeldt-Jakob (CJD) disease agent. Patients should report any symptoms that concern them which might be caused by virus infections.

GAMMAGARD LIQUID can make vaccines (e.g., measles, mumps, rubella, or chicken pox vaccines) not work as well. It may also affect your blood test results. Before you get any vaccines or have your blood tested, tell your healthcare provider that you take GAMMAGARD LIQUID.

The following is a list of common side effects seen in clinical trials of GAMMAGARD LIQUID:

PI (IV administration): Headache, fatigue, fever, nausea, chills/shaking chills, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, hives, asthma, throat pain, rash, joint pain, muscle pain, swelling, itching, and cardiac murmur.

PI (Subcutaneous administration) : Infusion site reactions (i.e., mild or moderate pain, swelling, itching, redness, bruising, and/or warmth), headache, fatigue, increased heart rate, fever, upper abdominal pain, nausea, vomiting, asthma, increased blood pressure, diarrhea, ear pain, canker sores, migraine, sore throat, and pain in extremity.

MMN (IV administration): Headache, blurred vision, chest discomfort, muscle spasms, muscular weakness, nausea, sore throat, ear pain, and pain in extremity.

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 accompanying full Prescribing Information, including the Patient Product Information.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If you would like to report an adverse reaction, contact Baxter Global Pharmacovigilance: 1-866-888-2472
or .

If you have a medical/clinical question regarding the use of GAMMAGARD PRODUCTS, contact Baxter Medical Information:
1-866-424-6724 or

References

  1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA. Baxter Healthcare Corporation.
  2. Data on file, Baxter Healthcare Corporation. 2011
  3. 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.