Immune globulin (intravenous) (IGIV)

What is the most important information I should know about 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.

What is IGIV?

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.

What should I discuss with my healthcare provider before taking IGIV?

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.

How should I take IGIV?

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.

What happens if I miss a dose?

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

What happens if I overdose?

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.

What should I avoid while taking 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.

What are the possible side effects of 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.

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.

What other drugs will affect 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.

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.

Where can I get more information?

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

What does my medication look like?

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.04. Revision date: 7/8/04.