CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra® Larger Vial Size Is Another Convenience Offering for People Managing Primary Immunodeficiency with Hizentra
KING OF PRUSSIA, Pa., Sept. 3, 2013 /PRNewswire/ -- CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a 10 g (50 mL) vial size for Hizentra®, Immune Globulin Subcutaneous (Human). Hizentra, the first and only 20 percent subcutaneous immunoglobulin therapy, keeps serum immunoglobulin G (IgG) levels consistent week to week to help protect people with primary immunodeficiency (PI) against infections. The new vial size, 10 g (50 mL), will be available in the U.S. in October.
PI is a group of rare and serious diseases of the immune system. Approximately 250,000 individuals (or one person per 1,200) in the U.S. are diagnosed with PI. The 10 g vial size of Hizentra will reduce the number of vials that patients must use when higher doses are required, thus increasing administration efficiency and reducing complexity of care.
"CSL Behring remains dedicated to providing every patient with options that will enhance his or her treatment experience," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring. "The availability of Hizentra in a 10 g vial will reduce vial preparation for infusion, therefore saving time for both patients and their caregivers."
In addition to the new 10 g (50 mL) vial, Hizentra is also available in 1 g (5 mL), 2 g (10 mL) and 4 g (20 mL) vials.
Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®, treats various forms of primary immunodeficiency (PI) in patients age 2 and over.
Hizentra should not be used if you have had serious negative reactions to immune globulin (Ig) preparations or a deficiency of an Ig known as IgA. Because Hizentra contains the amino acid proline as stabilizer, patients with hyperprolinemia (too much proline in the blood) should not take Hizentra.
Infuse Hizentra under your skin only; do not inject into a blood vessel.
Allergic reactions can occur with Hizentra. If your doctor suspects you are having a bad allergic reaction or are going into shock, treatment will be discontinued. Immediately tell your doctor or go to the emergency room if you have signs of such a reaction, including hives, trouble breathing, wheezing, dizziness, or fainting.
Tell your doctor about any side effects that concern you. Your doctor will monitor for potentially serious reactions that have been seen with Ig treatment, including thrombotic events (blood clotting); aseptic meningitis syndrome (brain swelling); osmotic nephropathy (a kidney condition); hemolysis (a blood problem) and transfusion-related acute lung injury.
The most common drug-related adverse reactions in the clinical trial for Hizentra were injection-site reactions (swelling, pain, redness, heat or itching); headache; back pain; diarrhea; tiredness; cough; rash; itching; nausea and vomiting.
Hizentra is made from components of human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Vaccines (such as measles, mumps and rubella) might not work as well if you are using Hizentra. Before receiving a vaccination, tell the healthcare professional that you are being treated with Hizentra. Also tell your doctor if you are pregnant or nursing, or if you plan to become pregnant.
For full prescribing information, visit http://www.hizentra.com/consumer/prescribing-information.aspx.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for 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 diseases in the newborn. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
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SOURCE CSL Behring