Solvent/detergent / heat treatment
The FVIII/VWF complex in ALPHANATE provides Natural Protection for patients with hemophilia A and von Willebrand disease
First dual-inactivated natural FVIII/VWF complex that is highly purified by affinity chromatography
- 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
Broad pathogen safety margin:
- Dual virus inactivation: solvent/detergent and heat treatment (80°C for 72 hours) provides an extra measure of safety
Three prion-elimination steps: FDA-approved labeling for reasonable assurance of removal for low levels of a vCJD model agent
ALPHANATE is made from human plasma. 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.
- Affinity chromatography provides a high-purity FVIII/VWF complex with high specific activity for increased quality and safety
- High content of functional VWF resulting in high in vivo recoveries in patients with VWD. Mean in vivo recovery of VWF ristocetin cofactor (VWF:RCo) of 3.3 ± 1.5 (IU/dL)/(IU/kg)
- VWF:RCo and FVIII potency on vial labels and folding cartons
|Diluent size||Product description||NDC number||Assay color code|
|5 mL||250 IU||68516-4601-1 or 68516-4611-1|
|5 mL||500 IU||68516-4602-1 or 68516-4612-1|
|10 mL||1000 IU||68516-4603-2 or 68516-4613-2|
|10 mL||1500 IU||68516-4604-2 or 68516-4614-2|
|10 mL||2000 IU||68516-4609-2 or 68516-4615-2|
- Stable for 3 years, up to the expiration date printed, when stored at or below 25 °C (77 °F)
Do not freeze
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Important safety information:
ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) 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.
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