Gammaplex (IGIV)

Immune globulin (IGIV) is used in adults and children who are at least 2 years old to treat primary immunodeficiencies such as X-linked agammaglobulinemia, common variable immunodeficiency, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Immune globulin is also used in adults and children who are at least 15 years old with idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and help prevent or control bleeding.

Immune globulin is also used to help prevent certain infections in people with low levels of immune globulin (hypogammaglobulinemia) or in those with B-cell chronic lymphocytic leukemia.

Immune globulin is also used to prevent coronary artery aneurysms in children with Kawasaki syndrome.

Immune globulin may also be used in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve nerve and muscle function and reduce disability.

Immune globulin may also be used for purposes not listed in this medication guide.

Gammaplex can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place.

Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.

This medicine can also harm your kidneys, especially if you have kidney disease or if you are using certain other medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.

You should not use immune globulin if you are allergic to it, or if you have:

• hyperprolinemia (high level of a certain amino acid in the blood);
• hereditary fructose intolerance, which makes it hard for you to digest fructose sugars (such as those in certain fruits or juices);
• immune globulin A (IgA) deficiency with antibody to IgA; or
• an allergy to corn.

Tell your doctor if you have or have ever had:

• migraine headaches;
• high blood pressure; or
• kidney disease.

Immune globulin can cause blood clots or kidney problems, especially in older adults or in people with specific health conditions. Tell your doctor if you have ever had heart or blood circulation problems, a stroke or blood clot, kidney disease, diabetes, paraproteinemia, or an infection such as sepsis, and if you use estrogens (including birth control pills or hormone replacement therapy), have been on long-term bed rest, or have a central intravenous (IV) catheter in place.

It is not known if immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Immune globulin is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Gammaplex may cause serious side effects. Call your doctor right away if you have:

• neck stiffness, increased sensitivity to light, painful eye movement, nausea, drowsiness;
• frequent vomiting, stomach pain;
• pounding in your neck or ears;
• abnormal blood tests (including low blood sugar and low blood sodium);
• a blood cell disorder--pale or yellowed skin, dark colored urine, or weakness;
• dehydration--dizziness, confusion, feeling very thirsty;
• kidney problems--swelling, urinating less, shortness of breath, rapid weight gain;
• lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• signs of a blood clot--sudden numbness or weakness on one side of the body, sudden cough or shortness of breath, chest pain, problems with vision or speech, pain or swelling in one leg.

Common side effects of Gammaplex may include:

• headache, pain, muscle or joint pain, swelling in your joints;
• fever, chills, sweating, flushing;
• stomach pain, nausea, vomiting, diarrhea;
• painful or difficult urination;
• increased blood pressure, fast heartbeats, dehydration, feeling like you might pass out;
• itching, rash, hives, dry skin;
• low blood cell counts;
• dizziness, tiredness, lack of energy, discomfort;
• stuffy nose or swelling in your nose, sneezing, sinus pain, cough, sore throat; or
• pain, swelling, burning, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Immune globulin is given as an infusion into a vein. A healthcare provider will give you this injection.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

Drink plenty of liquids while you are using Gammaplex to help improve your blood flow and keep your kidneys working properly.

You may be given other medications to treat certain allergic reactions or serious side effects.

You will be watched for a short time to make sure you do not have an allergic reaction.

You will need frequent medical tests. Your blood pressure will be constantly monitored, and your kidney function may need to be checked often.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using immune globulin.

Call your doctor for instructions if you miss an appointment for your immune globulin (IGIV) injection.

In a medical setting, an overdose will be treated quickly.

Do not receive a "live" vaccine. The vaccine may not work as well while you are using immune globulin. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Immune globulin can harm your kidneys, especially if you are also taking certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill".

This list is not complete. Other drugs may affect immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.