30 April 2013
CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.
28 February 2013
CSL Behring Receives FDA Approval to Expand the Indication for Corifact®
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
21 February 2013
CSL Behring Announces New Vial Size of Privigen® for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura
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.
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.
04 January 2013
CSL Behring and its Employees Give Back to their Communities by Supporting a Range of Charities Year-Round
CSL Behring and its employees helped numerous organizations throughout the United States in 2012, from local United Way chapters to patient advocacy groups, food banks and other agencies that provide vital services to people in need. With operations in King of Prussia, Pa., Kankakee, Ill. and Boca Raton, Fla., and CSL Plasma centers throughout the United States and sites in Knoxville, Tenn. and Indianapolis, Ind., the company and its employees impacted many people.
02 January 2013
CSL Behring Launches Its First Co-Pay Assistance Program to Ease Financial Burden of Treating Hereditary Angioedema
CSL Behring announced today the launch of a financial assistance program designed to cover patients’ out-of-pocket expenses for Berinert®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute laryngeal, facial and abdominal attacks of hereditary angioedema (HAE). HAE is a rare and potentially fatal genetic disorder. Berinert Co-Pay BENefit is the most recent addition to the Berinert Expert Network (B.E.N.®), a full-service support program for healthcare providers and HAE patients and their caregivers. Berinert is available through specialty pharmacies and distributors in the United States.
03 December 2012
CSL Behring Parent Company, CSL Limited, Issues Fourth Corporate Responsibility Report
CSL Behring’s parent company, CSL Limited (ASX:CSL), reaffirms the company’s commitment to responsible business practice and sustainable development in its fourth Corporate Responsibility Report – Our Corporate Responsibility 2012. The report details CSL’s performance across key corporate responsibility priority areas for the period July 1, 2011 through June 30, 2012.
01 August 2012
CSL Behring Awards Advocacy Grants to Patient Groups in
SIX STATES: NC, CA, WA, PA, IL, NY
CSL Behring announced today that it has awarded six patient advocacy organizations in the U.S. with Local Empowerment for Advocacy Development (LEAD) grants totaling nearly $70,000. LEAD grants are awarded semiannually and are intended to help local patient organizations achieve their advocacy objectives by further developing an existing initiative or developing a new one.
Important Safety Information for Berinert
Berinert®, C1 Esterase Inhibitor (Human), is for the treatment of ongoing, acute attacks of hereditary angioedema (HAE) affecting the abdomen, face or throat in adults and adolescents. The safety and efficacy of Berinert in preventing HAE attacks have not been established.
Do not use Berinert if you have experienced life-threatening allergic reactions or severe hypersensitivity to the product. Immediately report to your physician or an emergency department any signs or symptoms of allergic reactions to Berinert, including hives, chest tightness, wheezing, turning blue, fast heartbeat, and shock. Also report signs and symptoms of thrombosis that occur after infusing: including swelling and pain in the limbs or abdomen, chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech.
Berinert can be self-administered if you have been trained and advised to do so by your healthcare provider. Seek immediate medical attention if an HAE attack has progressed to a point where you will be unable to prepare or administer Berinert.
Call your doctor right away if swelling is not controlled after use of Berinert.
If you self-administer to treat a laryngeal attack, immediately seek medical attention afterward. If you self-administer for an abdominal attack, inform your physician so that other possible causes can be ruled out.
Because Berinert is made from human blood, the risk that it may transmit infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical studies, the most serious adverse reaction reported in subjects who received Berinert was an increased severity of pain associated with HAE. In the placebo-controlled clinical trial, the most common adverse reaction reported more often among subjects who received Berinert than those receiving placebo was dysgeusia (a bad taste in mouth).
Berinert has not been evaluated in pregnant women or nursing mothers; inform your doctor if you are pregnant or are planning to become pregnant, or if you are breastfeeding or plan to breastfeed. The safety and effectiveness of Berinert have not been established in children under 12 or adults over 65 years of age.
Please see full prescribing information for Berinert, including the patient product information.
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.