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GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA < 1 μg/mL in a 5% solution

There are five types of immunoglobulins (Ig), or antibodies, in the body: IgG, IgA, IgM, IgD, and IgE. Ig treatment replaces the IgG antibodies your body isn't making or isn't working properly.1 But some people with primary immunodeficiency (PI) need a low level of the IgA antibodies in their Ig treatment.1

GAMMAGARD S/D may be right for these individuals. It's an Ig treatment that contains a low level of IgA (<1mcg/mL). It's used to treat adults and children two years and older who have primary immunodeficiency. These include, but are not limited to, types of PI like congenital agammaglobulinemia, common variable immune deficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiences (SCID).2

Talk to your doctor to learn more about GAMMAGARD S/D.

We've got eligible patients with Primary Immunodeficiency (PI) covered!

Learn more about the MyIgCopayCard Program here.

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Detailed Important Safety Information

Please read below for Indication and Detailed Important Safety Information for GAMMAGARD S/D. Please see Full Prescribing Information, including Boxed Warning.

GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 microgram per mL in a 5% Solution

What is GAMMAGARD S/D?

  • GAMMAGARD S/D is a freeze-dried medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. GAMMAGARD S/D is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with primary immunodeficiency (PI). GAMMAGARD S/D is given into a vein (intravenously).
  • GAMMAGARD S/D is indicated for the treatment of PI in patients two years of age and older.
  • GAMMAGARD S/D is indicated for the prevention of bacterial infections in patients with low levels of IgG antibodies or recurrent infections associated with B-cell Chronic Lymphocytic Leukemia.
  • GAMMAGARD S/D is indicated for the treatment of adult chronic Idiopathic Thrombocytopenic Purpura patients to increase platelet count and to prevent and/or control bleeding.
  • GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.

Do not use GAMMAGARD S/D if you:

  • Have a known history of a severe allergic reaction to IgG or other blood products.
  • Have a known history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with <1 μg/mL IgA in a 5% solution

Before starting GAMMAGARD S/D, tell your healthcare professional if you:

  • Have history of thrombosis (blood clots), thrombotic events, poor kidney function or kidney failure
  • Are on a low sodium diet
  • Are sensitive to rubber latex

What is the most important information that I should know about GAMMAGARD S/D?

  • GAMMAGARD S/D can cause blood clots. Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of your body.
  • Kidney problems can occur in patient receiving intravenous IgG. Symptoms of a kidney problem may include: reduced urination, sudden weight gain or swelling in your legs.

GAMMAGARD S/D can cause other serious side effects. Call your healthcare professional or go to the emergency department right away if you get:

  • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
  • 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.

What are the possible or reasonably likely side effects of GAMMAGARD S/D?

The most common side effects of GAMMAGARD S/D are headache, nausea, chills, fatigue, fever, upper abdominal pain, diarrhea, back pain, infusion site pain, sweating, and flushing.

These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don't go away.

You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about GAMMAGARD S/D with your healthcare provider or pharmacist. The FDA-approved patient product labeling can be accessed by clicking here.

References:

  1. Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Diseases. 5th ed. Towson, MD: Immune Deficiency Foundation; 2013.
  2. GAMMAGARD S/D, Immune Globulin Intravenous (Human), IgA less than 1 µg/mL in a 5% Solution [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.