ALPHANATE® (antihemophilic factor/von Willebrand factor [human]) is the preferred pdFVIII product for the treatment of hemophilia A among hematologists practicing in an HTC


29.04.2015

  • ALPHANATE is physician preferred

Los Angeles (April 28, 2015).— Grifols, a leader in the production of plasma-derived medicines, announced today the results from a new survey showing that ALPHANATE is the preferred plasma-derived FVIIl among hematologists practicing in hemophilia treatment centers.  In the survey, ALPHANATE was preferred over the other 5 available plasma-derived FVIII products by a statistically significant margin [(p<0.05) 95% confidence interval].

The national blinded survey, conducted by Adivo Associates on behalf of Grifols between October 2014 and January 2015, included 75 hematologists  who specialize in treating hemophilia A. The hematologists spent a significant amount of treatment time in a hemophilia treatment center to meet minimum prescription level requirements for hemophilia A products.

"Since 1997, when ALPHANATE was introduced to the US market, Grifols has continued to place a significant amount of resources to enhance the product and obtain data on key clinical questions," said Keith Arbuckle, VP/GM of Hematology. "Late last year, Grifols introduced a 2000 IU assay range, which is the highest assay available for any pdFVIII product on the market. Grifols has also added several steps in manufacturing to enhance product safety, product transparency, and traceability. ALPHANATE represents our continued commitment to the history of innovation and service to the hemophilia community."

For more information about ALPHANATE, please click here.

Indications

ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is indicated for:

  • Control and prevention of bleeding in patients with hemophilia A
  • Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP®) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type3) undergoing major surgery

Important Safety Information

ALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ALPHANATE should be discontinued, and emergency treatment should be sought.

Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 von Willebrand disease (VWD) patients has been occasionally reported in the literature.

Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.

Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).

Rapid administration of a FVIII concentrate may result in vasomotor reactions.

Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

The most frequent adverse events reported with ALPHANATE in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain, and fatigue.

To view the full Prescribing Information for ALPHANATE, please click here.

Survey Methodology

Results are statistically significant with a 95% confidence interval with a 6.5% margin of error and are based on a blinded national survey of 75 HTC-based Hematologists from a list of federally and non-federally funded HTCs within the US, conducted by Adivo Associates, LLC on behalf of Grifols USA from October 2014 - January 2015.  In order to qualify to complete the survey, Hematologists must have been in practice between 2 and 35 years, spend greater than 50% of their professional time in an HTC setting, have a majority of their patient population with non-malignant bleeding disorders, and have prescribed plasma-derived FVIII within the last 3 years to treat Hemophilia A patients.  Respondents were asked to assume no difference in terms of availability, cost, and reimbursement when indicating their most preferred plasma-derived FVIII brand. The survey was conducted, and the results are validated, by a reputable, independent third party worldwide strategy consulting and market research firm, Adivo Associates LLC.


About Grifols

Grifols is a global healthcare company founded in 1940. In 2015, Grifols celebrates its 75th Anniversary of improving people's health and well being through the development of life-saving plasma medicines, diagnostics systems, and hospital pharmacy products. The company is present in more than 100 countries worldwide and is headquartered in Barcelona, Spain. Grifols is a leader in plasma collection with a network of 150 plasma donor centers in the U.S., and a leading producer of plasma-derived biological medicines. The company also provides a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks and transfusion centers, and is a recognized leader in transfusion medicine.