ALPHANATE Manufacturing Process
ALPHANATE uses a proven manufacturing process
Each plasma donation goes through extensive laboratory testing before it is approved for use
After each unit of plasma is extensively analyzed using FDA-required safety protocols, it is transferred to a Grifols manufacturing facility and then subjected to careful controls that protect its quality through a multiphased production process. During this time, fractionation takes place. During fractionation, clotting factors are separated from the rest of the plasma. The factors then go through 2 more treatments with the capacity to inactivate or eliminate pathogens.
Additional safety measures with the capacity to inactivate/eliminate pathogens
| Solvent/detergent treatment | Dry heat treatment |
|---|---|
| Solvent/detergent is added to the factor and has the capacity to inactivate pathogens. Afterward, the solvent/detergent is removed from the factor so that it is not in the final product. | After ALPHANATE is placed in the final container, it is freeze-dried and then heated in an oven. This step has the capacity to inactivate pathogens. |
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.
Each vial of ALPHANATE is laser etched so its origins can always be traced
Another feature that contributes to the safety of ALPHANATE is the ability to trace plasma that has been collected from the donor center to the final product. Each unit of plasma is coded and computer-traced throughout the collection, testing, and manufacturing processes.
This information is made available to healthcare providers using the PediGri® online system (www.pedigri.grifols.com).
To further enhance safety and deter tampering and counterfeiting, there is a laser-etched lot number on each vial of ALPHANATE and a holographic seal on each package.
For more information about the plasma donation, collection, purification, and manufacturing process, watch the plasma safety video below or visit www.GrifolsPlasma.com.
Indication
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.