Privigen

Generic Name: Immune Globulin Intravenous (Human), 10% Liquid
Date of Approval: July 26, 2007
Company: CSL Behring

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Treatment for: Primary Immunodeficiency, Chronic Immune Thrombocytopenic Purpura

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FDA Approves Privigen

The U.S. Food and Drug Administration (FDA) has approved Privigen (Immune Globulin Intravenous (Human), 10% Liquid), an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.

A 10 percent liquid preparation of polyvalent human immunoglobulin, Privigen offers healthcare professionals convenience and ease-of-use. It is the first and only proline-stabilized IVIg that is always ready for immediate use, requiring no refrigeration or reconstitution.

Clinical Studies

The FDA approved Privigen based on results of two pivotal open-label, prospective, multi-center clinical studies. One study was performed in the United States and Europe in subjects with PI, and the other study was performed in Europe in subjects with chronic immune thrombocytopenic purpura. In the PI study, 80 adult and pediatric subjects received Privigen every three or four weeks at doses ranging from 200 mg/kg to 888 mg/kg for a maximum of 12 months. The annual rate of serious bacterial infections (defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses), the primary endpoint, was 0.08 infections per subject per year. Pneumonia was reported in three subjects, and visceral abscess, osteomyelitis, and septic arthritis in one subject each. The annual rate of any infections, a secondary endpoint, was 3.55 infections per subject per year.

In the ITP study, 57 subjects with a platelet count of less than or equal to 20 x 10(9)/L received 1 g/kg Privigen twice on each of two consecutive days and were observed for 29 days. A total of 46, or 80.7% of subjects, responded to Privigen therapy with an increase of platelet count to greater than or equal to 50 x10(9)/L within seven days after the first study drug administration. Hemolysis occurred in eight subjects treated with Privigen in the ITP study. These cases all resolved uneventfully.

Important Safety Information

In clinical studies, Privigen has been shown to be safe. As with any medication, side effects may accompany treatment. The frequency of side effects was based on a review of 1,038 injections given during the clinical trial in the United States and Europe. Because Privigen is made from plasma, as are all commercial human polyvalent immunoglobulins, the risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Privigen is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA less than 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction. Such patients should only receive intravenous immune globulin with utmost caution and in a setting where supportive care is available for treating life-threatening reactions.

Boxed warning: Immune Globulin Intravenous Human (IGIV) products have been associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. While reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Privigen does not contain sucrose.

About Primary Immune Deficiencies

These are a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system, keeping the patient from fighting off infections caused by everyday germs. For individuals with PI - many of them children - infections may not improve with treatment as expected, and may keep returning. As a result, patients may face repeated rounds of antibiotics or be hospitalized for treatment. Repeated infections can lead to organ damage, which, over time, can become life-threatening. In some severe cases of PI, infections may result in a patient being hospitalized repeatedly. Some infections, such as meningitis, may even result in death. Nearly 100 types of PIs exist. Most are inherited, but in some cases the cause is unknown.

No single treatment works for all of the different types of PI. Infusions of replacement antibodies (immune globulins or Ig) can help supplement the immune system to prevent infection in nearly three-quarters of those people living with PI whose disease is tied to an antibody deficiency.

About Immune Thrombocytopenic Purpura

Immune Thrombocytopenic Purpura, or ITP, is an autoimmune disease in which the immune system attacks and destroys the body's own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting. There are two forms of ITP: acute ITP, which resolves within six months, and chronic ITP, which most often occurs in adults and by definition lasts six months or longer. The annual incidence of ITP is 100 to 115 in every one million people. In the U.S., approximately 200,000 people have the disorder.

ITP is characterized by a low number of platelets (less than30 x 10(9)/L), usually caused by the body's production of substances (antibodies) that coat the platelets and signal their elimination from the blood. Diagnosis of ITP is often made by excluding other possible causes of the low platelet count and bleeding. People with the disorder often have purple bruises on the skin called purpura, a sign that bleeding has occurred in small blood vessels under the skin. They can also have petechiae, small red splotches on the skin that resemble a rash.

Highlights of Privigen Prescribing Information

Immune Globulin Intravenous (Human), 10% Liquid

These highlights do not include all the information needed to use Privigen safely and effectively.
See full prescribing information for Privigen.

Privigen Indications and Usage

Privigen is an Immune Globulin Intravenous (Human), 10% Liquid indicated for treatment of:

• Primary immunodeficiency (PI)
• Chronic immune thrombocytopenic purpura (ITP)

Privigen Dosage and Administration

• PI – 200 to 800 mg/kg intravenously (IV) every 3 to 4 weeks. Recommended infusion rate: initially, 0.5 mg/kg/min (0.005 mL/kg/min); if well tolerated, may be gradually increased to 8 mg/kg/min (0.08 mL/kg/min).
• Chronic ITP – 1 g/kg IV daily for 2 consecutive days, for a total of 2 g/kg. Recommended infusion rate: initially, 0.5 mg/kg/min (0.005 mL/kg/min); if well tolerated, may be gradually increased to 4 mg/kg/min (0.04 mL/kg/min).
• Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Privigen if renal function deteriorates.
• For patients at risk of renal dysfunction or thrombotic events, administer Privigen at the minimum infusion rate practicable.

Privigen Dosage Forms and Strengths

5 g in 50 mL solution, 10 g in 100 mL solution, 20 g in 200 mL solution

Privigen Contraindications

• Anaphylactic or severe systemic reactions to human immunoglobulin
• Hyperprolinemia (Privigen contains the stabilizer L-proline)
• Individuals with selective IgA deficiency can develop antibodies to IgA and are at greater risk of developing severe hypersensitivity and anaphylactic reactions

Privigen Warnings and Precautions

• Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
• Aseptic meningitis syndrome has been reported with Privigen and other IGIV treatments, especially with high doses or rapid infusion.
• Hemolysis has been reported with Privigen and other IGIV treatments. Monitor patients for hemolysis and hemolytic anemia.
• Monitor patients for pulmonary adverse reactions; if transfusion-related acute lung injury is suspected, test the product and patient for antineutrophil antibodies.
• Thrombotic events have been reported with Privigen and other IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
• Products made from human plasma can contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Privigen Adverse Reactions

• PI – Most common adverse reactions are headache, pain, nausea, fatigue, and chills.
• Chronic ITP – Most common adverse reactions are headache, pyrexia/hyperthermia, and anemia.

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-800-504-5434 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Privigen Drug Interactions

IgG administration can transiently impair efficacy of live virus vaccines.

Privigen Use In Specific Populations

In patients over age 65 at risk of developing renal insufficiency, do not exceed the recommended dose, and infuse Privigen at a rate less than 2 mg/kg/min (0.02 mL/kg/min).

Privigen Patient Counseling Information

• Renal Dysfunction
  Instruct patients to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath. Such symptoms may suggest kidney damage.
• Aseptic Meningitis Syndrome (AMS)
  Instruct patients to immediately report signs and symptoms of AMS. These symptoms include severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
• Hemolysis
  Instruct patients to immediately report signs and symptoms of hemolysis. These symptoms include fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine.
• Transfusion-Related Acute Lung Injury (TRALI)
  Instruct patients to immediately report signs and symptoms of TRALI, which is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. TRALI typically occurs within 1 to 6 hours following transfusion.
• Transmissible Infectious Agents
  Inform patients that Privigen is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses, and, theoretically, the CJD agent). Explain that the risk that Privigen may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing.
• Live Virus Vaccines
  Inform patients that administration of IgG may transiently impair the effectiveness of live virus vaccines (e.g., measles, mumps, and rubella) and to notify their immunizing physician of recent therapy with Privigen.

Manufactured by:
CSL Behring AG
Berne, Switzerland

US License No. 1766

Distributed by:
CSL Behring LLC
Kankakee, IL 60901 USA

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