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Information for Patients

About Primary Immunodeficiency Disease (PIDD)

The immune system acts to protect the body against infection.11 These infections may be due to bacteria, viruses, fungi, or parasites. The immune system uses lymphocytes (a type of white blood cell), immunoglobulins (antibodies), and other cells to fight these foreign invaders.12

When a person has an immune deficiency, one or more parts of the immune system fail to work. If a person is born with this condition, it is called primary immunodeficiency disease (PIDD). 4,11 People with primary immunodeficiency disease have difficulty fighting off infections, due to inadequate antibody production.12

If a person's body lacks immunoglobulin, a replacement immunoglobulin can be given.

This replacement immunoglobulin has been extracted from carefully screened donated human plasma (the liquid portion of blood). When a person is given a replacement immunoglobulin, it is called immunoglobulin therapy, or immunotherapy for short.4,8

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About Immune Thrombocytopenic Purpura (ITP)

Another type of immune disorder is immune thrombocytopenic purpura (ITP), a bleeding disorder that often causes purple bruises on the skin. ITP also may cause life-threatening bleeding in the brain or other organs.4

To understand ITP, it’s best to define each of the terms that make up its name. Immune refers to the fact that the immune system mistakenly attacks certain cells in a person’s own blood. Thrombocytopenic (throm-bo-cy-toe-PEE-nick) indicates that the illness is related to low levels of thrombocytes, also called platelets. These are fragments of cells in our blood that help stop bleeding. And purpura (PURR-purr-ah) refers to the purplish-looking bruised areas of the skin where bleeding has occurred.13

There are two forms of ITP: acute, which occurs most commonly in children and lasts for less than six months; and chronic, which generally affects adults between the ages of 20 and 40. Privigen is indicated for the treatment of chronic ITP. Chronic ITP lasts longer because patients may suffer from repeated bleeding attacks (relapses).13

Immunoglobulin therapy is used as a treatment to increase platelet counts in order to help control bleeding.7

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About Immunoglobulin Therapy

Immune globulin (Ig), also known as gammaglobulin, immunoglobulin, or immune serum globulin, has been used over the past half century for the treatment and prevention of various diseases.7

Today, three routes of administration for Ig are approved in the United States: intravenous (IV, or through the vein), intramuscular (IM, or into the muscle), and, most recently, subcutaneous (SC, or under the skin).4 Privigen is only indicated for IV use.

Intravenous immunoglobulin is usually administered once every three or four weeks. Typically, a nurse in a hospital, in an infusion center, in a physician’s office, or in the patient's home administers therapy. IV infusions require a pole holding a bag of medication, a needle that's inserted into a vein in the arm, and an infusion pump that controls how much of and how fast the medication is delivered.

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© CSL Behring 2012. The product information presented on this site is intended for US residents only. 09PVG055610

Important Safety Information

Immune Globulin Intravenous (Human), 10% Liquid, Privigen® is indicated as replacement therapy for patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Privigen is also indicated to raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).

WARNING: Use of Immune Globulin Intravenous (IVIg) products, particularly those containing sucrose, have been associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. Privigen does not contain sucrose. Administer Privigen at minimum rate practicable in patients at risk of renal dysfunction or acute renal failure. At-risk patients include those with preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia; over 65 years of age; or receiving known nephrotoxic drugs. See full prescribing information for complete boxed warning.

Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.

Monitor patient vital signs throughout infusion of Privigen. In cases of severe hypersensitivity or anaphylactic reactions, discontinue administration and institute appropriate medical treatment. In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Also monitor patients with risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.

Patients could experience increased serum viscosity, hyperproteinemia or hyponatremia; infrequently, aseptic meningitis syndrome (AMS) may occur (most often with high doses and/or rapid IVIg infusion). There have been reports of IVIg-related hemolysis, hemolytic anemia, and pulmonary adverse events, including transfusion-related acute lung injury (TRALI). Avoid high-dose regimen where fluid volume is of concern.

Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical studies of patients being treated with Privigen for PI, the most serious adverse reaction was hypersensitivity (one subject). Adverse reactions observed in >5% of subjects with PI were headache, pain, nausea, fatigue, chills, vomiting, joint swelling/effusion, pyrexia, and urticaria.

In clinical studies of patients being treated with Privigen for chronic ITP, the most serious adverse reactions were AMS (one subject) and hemolysis (eight subjects). Adverse reactions seen in >5% of subjects with chronic ITP were headache, pyrexia/hyperthermia, positive DAT, anemia, vomiting, nausea, increases in conjugated and unconjugated bilirubin, hyperbilirubinemia, and increased blood lactate dehydrogenase.

Treatment with Privigen might interfere with a patient's response to live virus vaccines and could lead to misinterpretation of serologic testing.

For more information about Privigen, please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.