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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 (< 1 μg/mL). GAMMAGARD S/D is a medicine that is given in a vein (intravenously) to treat primary immunodeficiency (PI) in people 2 years and older.

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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IMPORTANT SAFETY INFORMATION

Please expand for Indication and Important Safety Information.

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

GAMMAGARD S/D can cause the following serious reactions: serious 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.


What is GAMMAGARD S/D?

GAMMAGARD S/D is a medicine that is given in a vein (intravenously) to:

  • Treat primary immunodeficiency (PI) in people 2 years and older.
  • Prevent infections caused by bacteria in people who have B-cell Chronic Lymphocytic Leukemia (CLL).
  • Prevent and/or control bleeding in adults who have chronic Idiopathic Thrombocytopenic Purpura (ITP)
  • Prevent weakness/bulging of the artery that supplies blood to the heart (coronary artery aneurysms) in children with Kawasaki syndrome.
IMPORTANT SAFETY INFORMATION

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

GAMMAGARD S/D can cause the following serious reactions:

  • Serious 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 S/D?

Do not use GAMMAGARD S/D if you:

  • Have had a severe allergic reaction to GAMMAGARD S/D

What should I avoid while taking GAMMAGARD S/D?

  • GAMMAGARD S/D 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 S/D.
  • 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 S/D?

GAMMAGARD S/D can cause serious side effects. If any of the following problems occur after starting GAMMAGARD S/D, 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.

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
  • Flushing

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or does not go away.

For additional safety information, click for Full Prescribing Information 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.

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.