Immune globulin intravenous (IGIV, for injection into a vein) is used to treat primary immunodeficiency.

IGIV is also used to increase platelets (blood clotting cells) in people with immune thrombocytopenic purpura.

IGIV is also used in to help prevent certain infections in people with B-cell chronic lymphocytic leukemia.

IGIV is also used in people with Kawasaki syndrome, to prevent aneurysm caused by a weakening of the main artery in the heart.

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

Gammagard S/D 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 you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.

IGIV is given as an infusion into a vein, usually once every 3 to 4 weeks. A healthcare provider will give you this injection.

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

You may need frequent blood or urine tests.

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

You may not be able to use this medicine if:

• you have had an allergic reaction to an immune globulin or blood product;

• you have immune globulin A (IgA) deficiency with antibody to IgA; or

• you are allergic to corn.

IGIV can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you have ever had:

• heart problems, blood circulation problems, or "thick blood";

• a stroke or blood clot;

• kidney disease;

• diabetes;

• an infection called sepsis;

• if you use estrogens (birth control pills or hormone replacement therapy);

• if you have been on long-term bedrest; or

• if you have a central intravenous (IV) catheter in place.

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

Tell your doctor if you are pregnant or breastfeeding.

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.

Call your doctor for instructions if you miss an appointment for your IGIV injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ask your doctor before receiving a "live" vaccine while using IGIV. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.

Gammagard S/D may cause serious side effects. Call your doctor at once if you have:

• a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;

• lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;

• signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or

• signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects of Gammagard S/D may include:

• headache, back pain, joint pain;

• fever, chills, sweating, warmth or tingling;

• stomach pain, nausea, diarrhea;

• increased blood pressure, fast heartbeats;

• dizziness, tiredness, lack of energy;

• stuffy nose, sinus pain; 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.

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

Other drugs may affect IGIV, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.