BAXTER RECEIVES HEALTH CANADA APPROVAL FOR SMALLEST MIXING VOLUME AVAILABLE FOR FACTOR VIII PRODUCTS IN CANADA
New 2.0 mL diluent for ADVATE allows quicker, more efficient infusions for young, pediatric patients in Canada with hemophilia A
MISSISSAUGA, ON, March 9, 2012 – Health Canada has approved use of 2.0 mL Sterile Water for Injection (SWFI) in the 250IU and 500IU dose sizes of ADVATE® [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a full-length factor VIII recombinant used to prevent and control bleeding episodes in people living with hemophilia A.
The 2.0 mL mixing volume, which is the smallest available for patients among recombinant factor VIII therapies available in Canada, reduces the time spent infusing by up to 60% compared to 5.0 mL volume , and offers a more convenient option for infusing smaller volumes, which is often preferable for young patients. Baxter is the first in the world to offer this advantage to hemophilia patients.
The 2.0 mL mixing volume is packaged with BAXJECT II, a device that helps patients prepare recombinant treatment in an easy, fast and safe way with its needleless design and built-in filters.
ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. Infused directly into the bloodstream, it works by temporarily raising the level of factor VIII in the blood, thus allowing the body’s blood clotting process to function properly. ADVATE is the only full-length recombinant factor VIII therapy processed without blood or blood additives, including human albumin or other plasma protein additives.
People with hemophilia have unique infusion needs. A variety of dosage sizes and formats enables healthcare providers to tailor a patient’s prescription to meet their unique needs with fewer vials, more appropriate dosing and less product wastage.
“Infusing factor therapy can be challenging, especially with infants and young children and we are providing more choices to meet individual treatment requirements,” said Dr. Adel Gehchan, Director, Medical Affairs, Baxter Corporation. “Baxter is dedicated to supporting the hemophilia community through advanced therapeutic solutions to help make therapy easier and more convenient, and the addition of the smaller 2.0 mL mixing volume for ADVATE further enables healthcare providers to tailor a patient’s prescription to meet their therapeutic needs.”
ADVATE was developed in response to the needs of the hemophilia community, who called for the removal of human and animal blood-derived additives from recombinant factor VIII therapies. ADVATE is a full-length (derived from the complete factor VIII gene) recombinant factor VIII therapy that is processed without any blood-based additives.
Since its introduction in 2003, more than 10 billion international units have been distributed to date to treat people living with hemophilia A in 53 countries worldwide including Canada, the United States, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, Colombia, Croatia, Hong Kong, Iceland, Iraq, Japan, Macau, Malaysia, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Uruguay and Venezuela.
ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of factor VIII preparations or known sensitivity to mouse or hamster proteins. The most common related adverse reactions observed during the ADVATE clinical studies include: headache, dizziness, pyrexia and positive anti-factor VIII antibody.
About Hemophilia A
People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary for blood to effectively clot. As a result, people with hemophilia A are prone to bleeding for a longer period of time than someone without the disease. If untreated, patients with severe hemophilia A can damage limbs or organs, and can even become life threatening. Hemophilia A affects 1 in 10,000 or about 3,000 Canadians.
Baxter Research and Development
For almost 45 years, Baxter has been a leader in hemophilia therapy innovation, having introduced the first commercially produced factor VIII concentrate to treat hemophilia in 1968. In 2012, Baxter is pleased to celebrate 20 years since it introduced RECOMBINATE [Antihemophilic Factor (recombinant)], the first genetically manufactured factor VIII concentrate.
Baxter focuses its scientific resources and leverages strategic collaborations to advance the treatment of hemophilia and blood clotting disorders. Building on its history of innovation, the company is developing therapies to provide less invasive dosing techniques, require less frequent infusions, and/or reduce the potential for inhibitor formation to improve the lives of people with bleeding disorders.
As a subsidiary of Baxter International Inc., Baxter Corporation manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. More information: www.baxter.ca.
Maximum infusion rate is 10mL/min [5mL (60 sec/10 mL) = 30 sec; 2mL (60 sec/10 mL) = 12 sec]