FDA Approves Subcutaneous Route of Administration for Gammagard Liquid

Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid for Patients with Primary Immunodeficiency

DEERFIELD, Ill.--(BUSINESS WIRE)--Jul 25, 2011 - Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of Gammagard Liquid 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency (PI). The approval of this new route of administration will allow physicians and PI patients to work together to determine which route of administration of Gammagard Liquid is most appropriate. Subcutaneous use of Gammagard Liquid allows patients to self-administer their therapy at home on a weekly basis.

"The FDA approval of a subcutaneous route of administration for Gammagard Liquid offers PI patients the option to administer Gammagard Liquid either intravenously or subcutaneously, depending on their individual needs," said Richard Schiff, M.D., Ph.D., medical director for Baxter's gammaglobulin trials. "Building upon years of strong clinical data of Gammagard Liquid, our subcutaneous clinical trial in patients with PI demonstrated efficacy consistent with that seen in other clinical studies of intravenous and subcutaneous immune globulin." (The most frequently reported adverse reactions were local site reactions, which occurred in 2.7% of infusions.)

"We've come to rely on Gammagard Liquid for our family as we work to ensure our three children, all born with PI, can lead lives with fewer infections," said Dayna Fladhammer, mother and caregiver. "Having participated in the Gammagard Liquid clinical trial for subcutaneous use, we appreciate that a brand we trust offers the flexibility of two routes of administration to meet each of our children's individual needs."

Baxter is highly committed to the PI community and supports advocacy organizations and treatment centers through unique programs focusing on patient care and continued access to therapy such as GARDian, a program providing educational resources, insurance support and guidance for therapy continuity. The GARDian program is also creating new features to support patients who choose Gammagard Liquid for subcutaneous use.

Gammagard Liquid is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older. It offers flexibility to clinicians who treat patients with PI, as it is now available via two routes of administration, in a total of five dosing sizes, and contains no added sugars, sodium, or preservatives. It is processed using a dedicated three-step viral inactivation/removal process.

About PI

Primary immunodeficiency (PI) encompasses more than 150 diseases of the immune system. According to the Immune Deficiency Foundation, approximately 250,000 persons in the United States have one of the primary immunodeficiency disorders. Immune globulin therapies can help restore immunoglobulin levels to near normal, helping the immune system to function properly by preventing infections or fighting them when they occur.

About Gammagard Liquid

Gammagard Liquid is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Gammagard Liquid was originally approved by the U.S. Food and Drug Administration (FDA) in September 2005. Also known as Kiovig outside the United States and Canada, it is approved in 51 countries worldwide.

Important Risk Information

  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammagard Liquid does not contain sucrose.
  • For patients at risk of renal dysfunction or failure, administer Gammagard Liquid at the minimum infusion rate practicable.

Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients over 65 years of age or judged to be at risk for renal dysfunction or thrombotic events, administer Gammagard Liquid at the minimum infusion rate practicable. In such cases, the maximal rate should be less than 3.3 mg/kg/min (< 2mL/kg/hr), and consider discontinuation of administration if renal function deteriorates.

Gammagard Liquid is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin.

Gammagard Liquid is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with the intravenous use of Gammagard Liquid and is theoretically possible following subcutaneous administration.

Severe hypersensitivity reactions may occur, even in patients who had tolerated previous treatment with human normal immune globulin.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving Gammagard Liquid.

Thrombotic events, including myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism have been reported in association with intravenous use of Gammagard Liquid. Thrombotic events have also been reported with subcutaneous administration of immune globulin. Patients at risk for thrombotic events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular disease, or a history of a previous thrombotic or thromboembolic event.

Aseptic Meningitis Syndrome may occur with IGIV treatment, and has been reported with intravenous use of Gammagard Liquid. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Gammagard Liquid contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immune globulin. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop due to enhanced RBC sequestration.

Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following treatment with IGIV products, including Gammagard Liquid.

Gammagard Liquid is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the classic Creutzfeldt-Jakob disease agent. This also applies to unknown or emerging viruses and other pathogens. No cases of transmission of viral diseases or vCJD have been associated with Gammagard Liquid.

Intravenous: The most serious adverse reaction seen during intravenous treatment in the clinical trials was two episodes of aseptic meningitis in one subject. The most common adverse reactions (observed in > 5% of subjects) were headache, pyrexia, fatigue, rigors, nausea, chills, dizziness, vomiting, migraine headache, pain in extremity, urticaria, cough, pruritus, rash, and tachycardia.

Subcutaneous: No serious adverse reactions were observed during the clinical trial of subcutaneous treatment. The most common adverse reactions during subcutaneous treatment (observed in > 5% of subjects) were local infusion site reactions. The most common systemic reactions were headache, fever, fatigue, increased heart rate, increased systolic blood pressure, and upper abdominal pain.

Please review the Gammagard Liquid Prescribing Information for full prescribing details.

http://www.baxter.com/products/biopharmaceuticals/downloads/gamliquid_PI.pdf

About Baxter

Baxter International Inc. (NYSE: BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Contact: Baxter International Inc.
Media Contact
Deborah Spak, (847) 948-2349
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Investor Contacts
Mary Kay Ladone, (847) 948-3371
Clare Trachtman, (847) 948-3085

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Posted: July 2011

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