KING OF PRUSSIA, Pa., Feb. 21, 2013 /PRNewswire/ -- CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human]. The new vial size will simplify preparation and administration of the product when high volumes of it are required. Privigen is approved for the treatment of patients with primary immunodeficiency (PID), a group of rare and serious diseases of the immune system, and provides effective protection against infection by assisting the body in maintaining a normal level of immunoglobulin. Privigen is also approved in the United States for chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. With the addition of the 40 g vial, Privigen will be available in four sizes in the United States, including 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL). The first supply of Privigen in this new vial size will be introduced in June.
"CSL Behring strives to bring new innovations to the healthcare marketplace and deliver products that enhance the patient experience," said Val Romberg, Senior Vice President, Research and Development. "The 40 gram vial size for Privigen continues that commitment by reducing the complexity of administration and increasing time savings for healthcare providers."
Privigen can be administered through pooled infusion using intravenous (IV) bags or through individual vial infusion – hung separately from the IV line. Patients who are administered Privigen are dosed based on body weight. For patients who require high doses of Privigen, the 40 g vial size of Privigen will reduce the required number of individual vial infusions or the need to pool multiple vials for an IV bag infusion.
Privigen® is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. In the US, Privigen is indicated as replacement therapy for patients with primary immunodeficiency (PID) associated with defects in humoralimmunity. 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.
Privigen is derived from human plasma. The risk of virus transmission 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.
For more information about Privigen, including full prescribing information, visit http://www.Privigen.com/Privigen-pi-Privigen-prescribing-information.aspx.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life of people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders, including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma.
Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Operations
SOURCE CSL Behring