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ALPHANATE can help you build a strong foundation for successful treatment of hemophilia A

ALPHANATE offers you the convenience of a 2000-IU assay. The 2000-IU FVIII ALPHANATE assay is the largest plasma-derived FVIII and von Willebrand factor ristocetin cofactor (VWF:RCo) assay available on the market.1

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FVIII Potency Diluent size
250 IU FVIII 5 mL
500 IU FVIII 5 mL
1000 IU FVIII 10 mL
1500 IU FVIII 10 mL
2000 IU FVIII 10 mL

ALPHANATE can be administered at up to 10 mL/min and can be stored at room temperature for up to 3 years for increased convenience.1


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ALPHANATE treatment case study

Plasma-derived FVIII/VWF treatment options for a hypothetical 60-kg patient requiring a dose of 100 IU/kg (6000 IU)1

US Products ALPHANATE® Antihemophilic Factor/von Willebrand Factor Complex (Human)1 Humate® P Antihemophilic Factor/von Willebrand Factor Complex (Human)2 Koate® Antihemophilic Factor (Human)3
Mean Half-Life of FVIII (Hemophilia A patients) 17.9 +/-9.6 hours 12.2 hours 16.1 hours
Total Infusion Volume 30 mL 90 mL 60 mL
Minimum Number of Vials 3 6 6
Infusion Rate ≤10 mL/minute 4 mL/minute ≤10 mL/minute
Overall Infusion Time ~3 minutes 22.5 minutes ~6 minutes
US Products Mean Half-Life of FVIII (Hemophilia A patients)
ALPHANATE® Antihemophilic Factor/von Willebrand Factor Complex (Human)1 17.9 +/-9.6 hours
Humate® P Antihemophilic Factor/von Willebrand Factor Complex (Human)2 12.2 hours
Koate® Antihemophilic Factor (Human)3 16.1 hours
US Products Total Infusion Volume
ALPHANATE® Antihemophilic Factor/von Willebrand Factor Complex (Human)1 30 mL
Humate® P Antihemophilic Factor/von Willebrand Factor Complex (Human)2 90 mL
Koate® Antihemophilic Factor (Human)3 60 mL
US Products Minimum Number of Vials
ALPHANATE® Antihemophilic Factor/von Willebrand Factor Complex (Human)1 3
Humate® P Antihemophilic Factor/von Willebrand Factor Complex (Human)2 6
Koate® Antihemophilic Factor (Human)3 6
US Products Infusion Rate
ALPHANATE® Antihemophilic Factor/von Willebrand Factor Complex (Human)1 ≤10 mL/minute
Humate® P Antihemophilic Factor/von Willebrand Factor Complex (Human)2 4 mL/minute
Koate® Antihemophilic Factor (Human)3 ≤10 mL/minute
US Products Overall Infusion Time
ALPHANATE® Antihemophilic Factor/von Willebrand Factor Complex (Human)1 ~3 minutes
Humate® P Antihemophilic Factor/von Willebrand Factor Complex (Human)2 22.5 minutes
Koate® Antihemophilic Factor (Human)3 ~6 minutes

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Properties of available plasma-derived and recombinant FVIII products

When choosing a FVIII product for yourself or a loved one, it is important to have enough information to make an informed choice. To view all currently available plasma-derived and recombinant FVIII products, download the Product Properties Chart

ALPHANATE - Indications

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.

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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.

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References:
  1. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols.
  2. Humate-P Prescribing Information. CSL Behring.
  3. Koate Prescribing Information. Kedrion Biopharma.