09 December 2013
CSL Behring Study Shows Kcentra® Superior to Plasma for Warfarin Reversal in Patients Requiring an Urgent Surgical Procedure
Data presented today by CSL Behring at the 55th Annual Meeting of the American Society of Hematology (ASH) showed Kcentra® (Prothrombin Complex Concentrate [Human]) was superior to plasma, the current standard of care in the U.S., in adult patients taking vitamin K antagonist therapy (VKA; e.g., warfarin) who required warfarin reversal prior to an urgent surgery or invasive procedure. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding and is not indicated for use in patients on VKA therapy requiring an urgent surgery or invasive procedure as evaluated in this study.
25 November 2013
CSL Behring Launches Innovative Test Kit Designed to Improve Diagnosis of Alpha-1
CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1)
, a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1). Launched during Alpha-1 Awareness Month, DNA1
is the only comprehensive Alpha-1 test available that identifies known and unknown clinically relevant genetic variants to help physicians achieve an accurate diagnosis.
15 October 2013
Plasma Donors Recognized For Their Lifesaving Contributions To The Treatment Of Rare Diseases
CSL Plasma, operator of one of the largest plasma collection networks in the world and parent company CSL Behring celebrate the contributions of donor-heroes during International Plasma Awareness Week (IPAW), October 13–20. The week-long observance, which is sponsored by the Plasma Protein Therapeutics Association and its member-companies, raises global awareness of source plasma collection and increases understanding of plasma protein therapies and rare diseases.
03 October 2013
CSL Behring Launches MySource™ at the National Hemophilia Foundation’s 65th Annual Meeting
People who are living with a rare and serious bleeding disorder will now have one-stop access to educational resources, financial support, and community connection programs through CSL Behring’s MySource™ program. Launched during the National Hemophilia Foundation’s (NHF) 65th Annual Meeting, MySource allows patients, caregivers and healthcare professionals to quickly and easily access CSL Behring’s patient-support resources at one online location www.MySourceCSL.com or with a one-on-one care coordinator (at 1-800-676-4266).
27 September 2013
FDA Approves New Dosing Option for CSL Behring’s Hizentra®
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®
, Immune Globulin Subcutaneous (Human), 20% Liquid, to include dosing once every two weeks (biweekly) for people diagnosed with primary immunodeficiency (PI).
, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once weekly immunoglobulin G (IgG) replacement therapy. Self-administered weekly or biweekly, Hizentra
delivers consistent levels of IgG to help protect those with PI against infections.
03 September 2013
CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra®
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.
13 August 2013
CMS Approves New Technology Add-On Payment for CSL Behring’s Kcentra™
CSL Behringtoday announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™
(Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra
, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration (FDA) in April 2013 for this use.
05 February 2013
Pursuing Your Dreams Despite a Lifelong Medical Condition
(Family Features) When Donna Schlacht’s son, Carl, was diagnosed with primary immunodeficiency (PI) at age 1, she resolved to not let Carl see his disorder as a barrier to pursuing his dreams. Today, Carl is a professional Supercross racer, and is helping to launch the I Am A ChamPIon campaign to inspire others to achieve their goals despite the challenges of living with PI.
Important Safety Information for Kcentra
Kcentra™, Prothrombin Complex Concentrate (Human), is 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. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding. 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 DIC. 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, arthralgia, and hypotension. 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.