Pharmacokinetic Profile
ALPHANATE provides a pharmacokinetic profile comparable to natural FVIII
ALPHANATE pharmacokinetic profile in hemophilia A treatment
- ALPHANATE pharmacokinetics are comparable to endogenous factor VIII (FVIII)1
- With ALPHANATE, the mean in vivo half-life of FVIII is 18 hours1
- In the absence of von Willebrand factor (VWF) in plasma, the half-life of FVIII is 1 hour1
Pharmacokinetics in hemophilia A1
| Pharmacokinetic parameters | Hemophilia A |
|---|---|
| Number of patients | 12 |
| In vivo half-life | 17.9 ± 9.6 hours (mean ± SD) |
| In vivo recovery in % | 96.7 ± 14.5% (mean ± SD) |
| In vivo recovery/IU FVIII infused/kg body weight | 2.4 ± 0.4 IU FVIII rise/dL plasma (mean ± SD) |
ALPHANATE pharmacokinetic profile in VWD treatment
ALPHANATE pharmacokinetics are comparable to other FVIII/VWF concentrates regardless of FVIII:VWF ratio.
Pharmacokinetics in von Willebrand disease (VWD)1
| Pharmacokinetic parameters | VWD |
|---|---|
| Number of patients | 14* |
| Half-life VWF:RCo | 7.67 + 3.32 hours (mean ± SD) |
| Half-life FVIII:C | 21.58 + 7.79 hours (mean ± SD) |
| Half-life VWF:Ag | 13.06 + 2.20 hours (mean ± SD) |
| In vivo recovery for VWF:RCo | 3.29 + 1.46 IU VWF:RCo/dL (mean ± SD) |
* 11 of 14 (79%) of the study patients had type 3 VWD.
FVIII, factor VIII; SD, standard deviation; VWD, von Willebrand disease; VWF, von Willebrand factor.
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.
Reference:
- ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols.