immune globulin (intravenous) (IGIV)

IGIV is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although IGIV is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using IGIV.

Treatment with IGIV has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of IGIV. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with IGIV has resulted in resolution of AMS without any lasting problems.

Immune globulin for intravenous administration (IGIV) is a sterilized solution obtained from pooled human blood. It contains the immunoglobulins (or antibodies) to protect against infectious agents that cause various diseases. Antibodies are substances in the blood that fight infections.

IGIV is used to reduce the risk of infection in individuals with poorly functioning immune systems such as those with HIV infection, hereditary immunodeficiency syndromes, chronic lymphocytic leukemia (CLL), and following bone marrow transplantation. IGIV is also used to increase platelet counts in individuals with idiopathic thrombocytopenic purpura (ITP) and to prevent coronary artery aneurysms (weakening of the main artery in the heart) associated with Kawasaki syndrome.

IGIV may also be used for purposes other than those listed here.

Do not use IGIV without first talking to your doctor if you have

• kidney disease;
• diabetes;
• a history of blood clots, stroke, or heart disease;
• IgA deficiency; or
• previously had an allergic reaction to an immune globulin product.

You may not be able to use IGIV, or you may require a dosage adjustment or special monitoring during treatment.

IGIV is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use IGIV without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether IGIV passes into breast milk. Do not use IGIV without first talking to your doctor if you are breast-feeding a baby.

Individuals over the age of 65 years may have an increased risk of kidney problems with the use of IGIV. Your doctor may prescribe a lower dose of the medication or special monitoring during treatment.

IGIV will be administered by intravenous (into a vein) injection by a healthcare provider in a hospital or clinic setting.

Your doctor may want you to have blood tests or other forms of monitoring during treatment with IGIV to monitor progress and side effects.

Your healthcare provider will store IGIV as directed by the manufacturer. If you are storing IGIV at home, your healthcare provider will provider storage instructions.

Contact your healthcare provider if a dose of IGIV is missed.

Seek emergency medical attention or contact your healthcare provider if an overdose of IGIV is suspected.

No information is available regarding an overdose of IGIV.

Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for six months following treatment with IGIV. These vaccines may not work properly when IGIV has been recently administered.

IGIV is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although IGIV is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using IGIV.

Treatment with IGIV has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of IGIV. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with IGIV has resulted in resolution of AMS without any lasting problems.

Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to IGIV.

Other less serious side effects may also occur. Upon injection of the medication, some patients experience the following:

• anxiety;
• flushing or sweating;
• stomach cramps;
• muscle or joint pain;
• dizziness;
• nausea or vomiting;
• fever or chills; or
• pain, tenderness, or irritation at the injection site.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for six months following treatment with IGIV. These vaccines may not work properly when IGIV has been recently administered.

It is not known whether other medications will interact with IGIV. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with IGIV.

Your pharmacist has additional information about IGIV written for health professionals that you may read.

IGIV is available with a prescription generically and under several brand names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.