HOBOKEN, N.J. (June 26, 2012) – Octapharma USA today announced that it has started an initiative to make octagam® (immune globulin intravenous [human] 5%), a therapy for Primary Immune Deficiency, widely available to covered entities in the 340B Drug Pricing Program, which is managed by the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA).
The 340B Drug Pricing Program is available to certain hospitals, clinics, and outpatient treatment facilities who qualify as “covered entities” under Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act.
“Octapharma is committed to providing therapies to treat life-threatening conditions to all patients, including those who are treated in facilities that have historically faced challenges accessing IGIV,” said Octapharma USA President Flemming Nielsen. “We are pleased that the supply of octagam® 5% is now sufficient to adequately serve 340B covered entities, that have in recent years experienced difficulties in accessing specialty drugs such as IGIV at 340B discount prices. Octapharma is committed to serving patient needs, regardless of where they receive treatment, and ensuring a steady supply of octagam® 5% to all our hospital customers.”
Octapharma USA intends to use ASD Healthcare of Frisco, Texas and FFF Enterprises of Temecula, Calif. as the contact point for distribution. More distributors will be added later in the year. Octapharma USA, a subsidiary of Octapharma AG, one of the world’s largest human protein product manufacturers, has been marketing octagam® 5% since 2004.
Octapharma’s commitment to making octagam® 5% available to 340B entities nationally will benefit those hospitals and medical facilities that face the constant challenge of obtaining adequate supplies of IGIV at the legally mandated discount rate. Over 17,000 covered entity sites participate in the 340B Program, including six categories of hospitals that are generally considered safety net providers, and 11 categories of non-hospital covered entities, such as federally qualified health centers and specialized clinics and treatment centers.
“Octapharma is extremely pleased to expand access to octagam 5% for 340B covered entities because the purpose of the national initiative is to maximize available healthcare resources and ensure that patient needs do not go unfulfilled,” said Nielsen. “Octapharma’s goal is to provide every patient the access to care they need. Providing patients with safe, high quality therapies is always our top priority.”
WARNING: ACUTE RENAL DYSFUNCTION AND RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age >65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these 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. octagam® (Human) 5% liquid does not contain sucrose.
IMPORTANT SAFETY INFORMATION
IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Epinephrine should be available immediately to treat any acute severe hypersensitivity reactions.
Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
Falsely elevated blood glucose readings may occur during and after the infusion of octagam® 5% liquid with some glucometer and test strip systems.
Hyperproteinemia, increased serum viscosity and hyponatremia occur in patients receiving IGIV therapy.
Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
Aseptic Meningitis Syndrome has been reported with octagam® 5% liquid and other IGIV treatments, especially with high doses or rapid infusion.
Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration.
IGIV recipients should be monitored for pulmonary adverse reactions (TRALI).
The product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
Please review the complete octagam® (Human) 5% liquid prescribing information at http://www.octapharma.com/en/about-octapharma/products-therapies/immunotherapy/octagam.html and then click on “Octagam_5__SPC_for_USA.pdf”.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the world’s largest human protein products manufacturers and has been committed to patient care and medical innovation for nearly 30 years. Octapharma’s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous. In the U.S., Octapharma markets octagam® (immune globulin intravenous [human] 5%) to treat primary immune deficiencies; Albumin (human)® for the restoration and maintenance of circulating blood volume; and wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [human]), which has received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for certain types of von Willebrand Disease. Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com or www.wilateusa.com.
Fred Feiner, Yankee Public Relations
800-977-1910, Ext. 4