About Grifols

Grifols is a global healthcare company with more than 75 years of history improving the health and well-being of people around the world. We produce essential plasma medicines for patients and provide hospitals, pharmacies, and healthcare professionals with the tools, information, and services they need to efficiently deliver expert medical care.

Our three divisions–Bioscience, Diagnostic, and Hospital–develop, produce, and market innovative products and services available in more than 100 countries.

With the world's largest network of plasma donation centers, the Grifols Bioscience Division is a leading producer of plasma medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable, consistent source of plasma medicines worldwide, Grifols has an all-inclusive process that begins with plasma collection and continues through the fractionation, purification, and production at its three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California).

A leader in transfusion medicine, the Grifols Diagnostic Division advances patient care with diagnostic solutions to improve disease detection and management and simplify laboratory operations. The Grifols Hospital Division provides intravenous (IV) therapies, clinical nutrition products, and hospital pharmacy systems, including systems that automate drug compounding and drug inventory control systems.

Headquartered in Barcelona, Grifols employs approximately 14,700 people in 30 countries.  Ensuring quality, integrity, and safety in all activities is a crucial to our mission, as our products are of vital importance to the health and quality of life of patients we serve.

For more information, visit www.grifols.com

Watch the official video to learn more about Grifols

For more information about Grifols, visit www.GrifolsUSA.com

Indications

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

  • Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor VIII (FVIII) deficiency due to 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 (type 3) 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 with ALPHANATE. Discontinue use of ALPHANATE if hypersensitivity symptoms occur, and initiate appropriate treatment.

Development of procoagulant activity-neutralizing antibodies (inhibitors) has been detected in patients receiving FVIII-containing products. Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests.

Thromboembolic events have been reported with AHF/VWF complex (human) in VWD patients, especially in the setting of known risk factors.

Intravascular hemolysis may occur with infusion of large doses of AHF/VWF complex (human).

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

Because ALPHANATE is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

Monitor for development of FVIII and VWF inhibitors. Perform appropriate assays to determine if FVIII and/or VWF inhibitor(s) are present if bleeding is not controlled with expected dose of ALPHANATE.

The most frequent adverse drug reactions reported with ALPHANATE in >1% of infusions were pruritus, headache, back pain, paresthesia, respiratory distress, facial edema, pain, rash, and chills.

Please see full Prescribing Information for ALPHANATE.

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.