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16 December 2014
CSL Behring Submits Biologics License Application for FDA Approval of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) for Hemophilia B Patients
CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Once approved by the FDA, rIX-FP (Coagulation Factor IX {Recombinant}, Albumin Fusion Protein) will provide people with hemophilia B and their physicians a long-acting treatment option with dosing intervals up to 14 days. More.

08 December 2014
One Woman's Story: Living and Helping Others with Inherited Lung Disorder
(Family Features) Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious genetic form of emphysema called Alpha-1 Antitrypsin Deficiency, also known as Alpha-1. More.

04 December 2014
CSL Issues “Our Corporate Responsibility 2014” Report
CSL Behring’s parent company CSL Limited (ASX:CSL) has issued its annual corporate responsibility report – “Our Corporate Responsibility 2014.” The report details the global biopharmaceutical company’s performance across key priority areas from July 1, 2013 through June 30, 2014 – recording another strong performance led by CSL Behring. More.

01 December 2014
CMS Extends New Technology Add-On Payment for CSL Behring’s Kcentra®
CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]) through September 2015 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra, the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013. More.

29 October 2014
CSL Behring Announces Winners of its 13th Annual Gettin’ in the GameSM Junior National Championship Program
CSL Behring announced that William McCarthy from the Western Pennsylvania Chapter of the National Hemophilia Foundation and Nicholas Cleghorn from the Bleeding Disorders Advocacy Network are the national winners of the 2014 Gettin' in the GameSM Junior National Championship (JNC) program in golf and baseball, respectively. The JNC, launched in 2002, is CSL Behring’s annual baseball and golf competition that encourages kids to remain active despite the challenges a bleeding disorder can pose, while allowing them to develop life-long connections with other members of the community. More.

28 October 2014
CSL BEHRING SIGNS STRATEGIC DEVELOPMENT AGREEMENT WITH ENABLE INJECTIONS TO MARKET NOVEL NEW DRUG DELIVERY DEVICE
CSL Behring announced today that its affiliate company, CSL Behring AG, of Bern, Switzerland and Enable Injections, LLC, of Franklin, Ohio have signed a long-term development agreement for a new and innovative drug delivery system intended to improve the comfort, convenience and treatment compliance for patients with rare and serious diseases. More.

13 October 2014
PLASMA DONORS RECOGNIZED DURING INTERNATIONAL PLASMA AWARENESS WEEK FOR HELPING SAVE LIVES
CSL Behring and its subsidiary, CSL Plasma, join the Plasma Protein Therapeutics Association (PPTA) in saluting the contributions of plasma donors during International Plasma Awareness Week (IPAW), celebrated October 12-18. More.

30 September 2014
CSL Behring Expands Manufacturing Facility in Kankakee, Illinois to Meet Patients' Growing Needs
CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food & Drug Administration (FDA) has granted approval. The expansion significantly increases plasma processing and albumin production capacity in the Kankakee, Ill. facility. More.

18 August 2014
Early Diagnosis of Children with Primary Immunodeficiencies Focus of National Awareness Campaign for School Nurses
School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical conditions such as primary immunodeficiency (PI). More.

20 May 2014
CSL Behring Launches Hizentra® Co-Pay Relief Program
People managing primary immunodeficiency (PI) with CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human]) may now be eligible for financial support through the Hizentra® Co-Pay Relief Program. The new program offers eligible U.S. patients up to $4,000 per year to be applied toward Hizentra co-payments, deductibles and coinsurance. Out-of-pocket therapy costs will be processed seamlessly through the electronic billing systems of specialty pharmacies and physician offices, which means no paperwork is required for the patient, pharmacist or physician. More.

07 May 2014
Feature Story: A Mother's Health
Learning you have a rare, chronic medical condition can be unsettling, frustrating and downright scary. For primary immunodeficiency (PI) patient Rebecca Johnson, 33, it also made her question whether she could realize her dream of becoming a mother. More.

25 March 2014
CSL Behring Launches My Access™ Cost Share Program during Hemophilia Awareness Month
People who are treating hemophilia A or von Willebrand Disease (VWD) with a CSL Behring therapy may now be eligible for financial support through the company’s My Access™ program. My Access helps hemophilia A and VWD patients, who have private insurance, cover the out-of-pocket costs, up to $12,000, associated with treatment. More.

24 March 2014
Patient Advocates and Social Workers Will Be Trained on Intricacies of Affordable Care Act with CSL Behring Grant
Navigating the complexities of the Affordable Healthcare Act (ACA) can be challenging, particularly where patients with chronic medical disorders such as hemophilia and von Willebrand disease are concerned. CSL Behring is awarding a Local Empowerment for Advocacy Development (LEAD) grant to help bleeding disorder patients develop a clearer understanding of ACA and potential areas of concern. More.

01 March 2014
Patient Satisfaction and Convenience Increased with Current Hereditary Angioedema Treatment Options, According to Study Findings
Findings announced by CSL Behring today show that current hereditary angioedema (HAE) treatment options, such as C1 Esterase Inhibitor (C1-INH) concentrate, are allowing for greater patient satisfaction, higher rates of home treatment and a decrease in the number of hospitalizations and visits to the emergency room. HAE is a rare, potentially fatal swelling disorder caused by a deficiency of C1-INH. Until recently, only limited therapeutic options were available for patients in the U.S. with the condition. Today, HAE patients can choose from multiple options to address their condition. The 46-question online survey of physicians, which was conducted between March and June 2013, closely patterned after an initial survey conducted between October 2009 and February 2010. The data were presented at the 2014 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. More.

20 February 2014
CSL Behring and CSL Plasma Employees Open Their Hearts to Those in Need
You can tell a lot about a company and its employees by the way they give back to the community. CSL Behring, its subsidiary, CSL Plasma and their employees do just that, year-round, supporting a wide range of organizations that provide services to people in need. More.

Important Safety Information for Kcentra

Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The safety and efficacy of Kcentra in pediatric use have not been studied, and Kcentra should be used in women who are pregnant or nursing only if clearly needed.

Please see full prescribing information for Kcentra.


MTL07-12-0002 10/2012
© 2014 CSL Behring