How to Use ALPHANATE
Build on the convenience of the easy reconstitution and administration of ALPHANATE
The availability of ALPHANATE in a large 2000-IU vial size with low diluent volume provides greater convenience in the form of1-3:
- Less volume
- Fewer syringes
- Shorter daily infusion time
ALPHANATE is the only FVIII/VWF complex product to offer 5 convenient vial sizes with low diluent volumes.1
| Potency | Diluent size |
|---|---|
| 250 IU FVIII range | 5 mL |
| 500 IU FVIII range | 5 mL |
| 1000 IU FVIII range | 10 mL |
| 1500 IU FVIII range | 10 mL |
| 2000 IU FVIII range | 10 mL |
ALPHANATE can be stored at room temperature for up to 3 years, so you don't need to worry about refrigeration.1
ALPHANATE reconstitution
Every package of ALPHANATE comes with a Mix2Vial®* device for easy reconstitution. Watch the Mix2Vial® reconstitution demonstration below.
Easy Reconstitution and Administration
Storing and infusing ALPHANATE
ALPHANATE is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted ALPHANATE may be stored at room temperature (not to exceed 30°C) prior to administration, but administer intravenously within 3 hours. Discard any unused contents into an appropriate safety container. Do not administer ALPHANATE at a rate exceeding 10 mL/min.1
DemoPacks are available for instructional purposes so patients, parents, and nurses can become familiar with this easy-to-use transfer set. To request DemoPacks, please contact Grifols Customer Service at 888-GRIFOLS (888-474-3657) or by submitting an electronic request.
*Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
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.
- Humate-P Prescribing Information. CSL Behring.
- Koate Prescribing Information. Kedrion Biopharma.