Product Properties
Properties of FVIII products
For plasma-derived and recombinant products available in the United States
View the product properties for all available plasma-derived and recombinant FVIII products currently licensed for hemophilia A or von Willebrand disease treatment in the United States.
ALPHANATE treatment case study
Scott D, 17-year-old diagnosed with severe hemophilia A. Due to the severity of his disease, his healthcare professional calculated an individualized dose to achieve the desired FVIII level. Scott self-administers FVIII to control bleeding. 100 IU/kg x 60 kg = 6000-IU dose.
Plasma-derived FVIII treatment options for Hemophilia A.1,2
| ALPHANATE1 | KOATE® (Antihemophilic Factor [Human])2 | |
|---|---|---|
| Number of vials needed | 3 vials (2000 IU/10 mL) | 6 vials (1000 IU/10 mL) |
| Amount of diluent | 30 mL | 60 mL |
| Infusion rate | 10 mL/min | 10 mL/min |
| Infusion time | 3 minutes | 6 minutes |
| Number of vials needed | |
| ALPHANATE1 | 3 vials (2000 IU/10 mL) |
| KOATE® (Antihemophilic Factor [Human])2 | 6 vials (1000 IU/10 mL) |
| Amount of diluent | |
| ALPHANATE1 | 30 mL |
| KOATE® (Antihemophilic Factor [Human])2 | 60 mL |
| Infusion rate | |
| ALPHANATE1 | 10 mL/min |
| KOATE® (Antihemophilic Factor [Human])2 | 10 mL/min |
| Infusion time | |
| ALPHANATE1 | 3 minutes |
| KOATE® (Antihemophilic Factor [Human])2 | 6 minutes |
KOĀTE is a registered trademark of Kedrion Biopharma Inc.
FVIII, factor VIII.
KOĀTE (Antihemophilic Factor (Human)) is a medicine used for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). KOĀTE is not approved for the treatment of von Willebrand disease.
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.
References:
- ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols.
- Koāte Prescribing Information. Kedrion Biopharma Inc.