OREANDA-NEWS. April 22, 2015. Baxter International Inc. (NYSE:BAX) is celebrating the fifth annual World Primary Immunodeficiency Week Campaign, April 22 - 29, 2015, by collaborating with the International Patient Organisation for Primary Immunodeficiencies (IPOPI) to advance the global state of care for primary immunodeficiencies (PI, defined as a large group of disorders in which part of the body's immune system is missing or does not function properly). World PI Week, for which Baxter was the founding sponsor and remains the lead supporter, is led by a consortium of clinical societies, patient organizations and research foundations from around the world, aiming to raise awareness and improve the diagnosis and treatment for people with PI.

As part of Baxter's commitment to supporting the global PI community, the company is working with IPOPI to support the implementation of "Primary Immune Deficiencies - Principles of Care," a landmark document developed by an interdisciplinary working group of leading clinician experts in PI that was recently published in Frontiers of Immunology.1  The paper addresses key principles of optimal care for PI, including the importance of access to early diagnosis and specialist care, the critical role of specialized centers and patient support groups, the importance of registries and need for international collaborations for scientific research, and advancing treatment options.

"The Principles of Care document is a Call to Action for healthcare policy makers to join us in taking strong and decisive action to ensure that people with primary immune deficiency disorders are diagnosed early and have access to treatment options and optimal care throughout the world," said Johan Prevot, Executive Director of IPOPI. "Baxter's support will help IPOPI ensure this document is accessible and more easily utilized as the global patient community seeks implementation of these principles at the national level."

Baxter has a long history of global leadership in advancing the quality of care for primary immune deficiency disorders. Baxter supports efforts to improve awareness and diagnosis of PI in the United States through its ImmunoView program, which provides patients with diagnostic and educational resources, as well as through active sponsorship of patient organizations around the globe. Further, the company focuses on the needs of the PI community by developing new treatments, including HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], a once-monthly subcutaneous treatment for adult patients with PI recently launched in Europe and the United States.

"As the founding sponsor of World PI Week and a long-standing contributor to the PI community, Baxter has dedicated its efforts to advance care and address the individualized needs of people with primary immune deficiencies through product innovation as well as patient support programs in the United States," said Ron Lloyd, leader of Baxter's Immunology organization. "We continue to seek new ways to address the needs of patients, families and the global community with new treatments and solutions that aim to reduce the burden of PI worldwide."

About World PI Week
World PI Week offers an opportunity to inform and educate medical professionals, researchers, health policy-makers, schools and families, and the general public about primary immunodeficiencies (PI). Through events and activities promoting the warning signs of PI, the global PI community is making positive changes around the world in support of people living with PI. For more information, please visit www.worldpiweek.org.

Organizations actively involved in World PI Week include the African Society for Immunodeficiencies (ASID), the Latin American Society for Immunodeficiencies (LASID), the European Society for Immunodeficiencies (ESID), the International Patient Organisation for Primary Immunodeficiencies (IPOPI), the Jeffrey Modell Foundation (JMF), the European Federation of Immunological Societies (EFIS), the International Nursing Group for Immunodeficiencies (INGID), Immunodeficiency Canada, the Immune Deficiency Foundation (IDF), the Clinical Immunology Society (CIS), and the Plasma Protein Therapeutics Association (PPTA).

About Primary Immunodeficiencies
PI includes a group of disorders in which part of the body's immune system is missing or does not function properly, resulting in frequent infections and increased risk of life-threatening complications. It is estimated that as many as six million people are affected by PI worldwide, yet the majority of sufferers remain undiagnosed due to varying signs and symptoms that are often misdiagnosed or undertreated.2

About the Principles of Care
"Primary Immune Deficiencies - Principles of Care" document was developed by an Interdisciplinary working group of 31 leading clinician experts in PI care from 11 countries on five continents, and led by IPOPI. Over a 2-year period, the group reviewed current best practice care and guidelines, and assessed the needs of those providing or receiving PI care and treatment worldwide. Representatives from patient organizations and specialist immunology nurses were included. Baxter was not involved in the research and resulting published paper.

About HYQVIA
HYQVIA is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. Safety and efficacy of chronic use of recombinant human hyaluronidase in HYQVIA have not been established in conditions other than PI.

HYQVIA is a product consisting of Immune Globulin Infusion 10% (Human) and Recombinant Human Hyaluronidase (developed by Halozyme Therapeutics). The immune globulin component, a 10% solution that is prepared from large pools of human plasma consisting of at least 98% IgG, contains a broad spectrum of antibodies and provides the therapeutic effect. The Recombinant Human Hyaluronidase of HYQVIA increases dispersion and absorption of the Immune Globulin Infusion 10% (Human).

Important Risk Information
Thrombosis may occur with immune globulin products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

HYQVIA is contraindicated in patients who have a history of anaphylactic or severe systemic reactions to the administration of IgG; in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity; and in patients with known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA.

Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG. Patients with antibodies to IgA are potentially at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Non-neutralizing antibodies to the recombinant human hyaluronidase component may develop. The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in adult male testes, epididymis, and sperm. It is unknown whether these antibodies may interfere with fertilization in humans. The clinical significance of these antibodies is unknown.

Aseptic Meningitis Syndrome (AMS) has been reported to occur with IgG products, including Immune Globulin Infusion 10% (Human) administered intravenously and subcutaneously.

Discontinuation of IgG treatment has resulted in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to two days following intravenously administered IgG, perhaps more frequently in association with high dose (2 g/kg) intravenously administered IgG.

IgG products, including HYQVIA, contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with IgG. These antibodies may cause a positive direct antiglobulin reaction and hemolysis. Acute intravascular hemolysis has been reported following intravenously administered IgG, including Immune Globulin Infusion 10% (Human) administered intravenously, and delayed hemolytic anemia can develop due to enhanced RBC sequestration.

Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur upon use of IgG products administered intravenously, especially those containing sucrose. HYQVIA does not contain sucrose.

Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk for developing acute renal failure.

Infusion into or around an infected area can spread a localized infection.  Do not infuse HYQVIA into these areas due to potential risk of spreading a localized infection.

Non-cardiogenic pulmonary edema (TRALI) may occur with intravenously administered IgG and has been reported to occur with Immune Globulin Infusion 10% (Human) administered intravenously.

TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.

Because the Immune Globulin Infusion 10% (Human) of HYQVIA is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant CJD (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens. No cases of viral transmission or CJD have been associated with HYQVIA.

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield false positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs') test.

Common adverse reactions observed in clinical trials in >5% of subjects were: local reactions, headache, antibody formation against recombinant human hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting.

Please see accompanying full prescribing information, including boxed warning for HYQVIA at: http://www.baxter.com/downloads/healthcare_professionals/
products/HYQVIA_PI.pdf.

About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, 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.

1Chapel H et al. Primary immune deficiencies - principles of care. Front Immunol. 5:627. Available online at: http://journal.frontiersin.org/article/10.3389/fimmu.2014.00627/full
2Bousfiha AA et al. Primary immunodeficiency diseases worldwide: more common than generally thought. J Clin Immunol. 2013 Jan;33(1):1-7.