Flebogamma (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 reasons not mentioned in this medication guide.

Flebogamma can lead to blood clots. The risk is higher in older adults or in individuals who have a history of blood clots, heart issues, or blood circulation problems. Blood clots are also more likely to occur during long periods of bedrest, when using birth control pills or hormone replacement therapy, or when a central intravenous (IV) catheter is in place.

Contact your doctor immediately if you experience chest pain, difficulty breathing, rapid heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.

This medicine can also damage your kidneys, especially if you have kidney disease or are taking certain other medications. Inform your doctor right away if you notice 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, a condition that makes it hard for you to digest fructose sugars (such as 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 certain 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 notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

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

Flebogamma may lead to serious side effects. Contact your doctor immediately 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, issues with vision or speech, pain or swelling in one leg.

Common side effects of Flebogamma 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 faint;
• 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. Contact 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 Flebogamma 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 guidance if you miss your appointment for your immune globulin injection.

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

Avoid getting a "live" vaccine. The vaccine may not be as effective while you are using immune globulin. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Immune globulin can damage 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 interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.