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. The higher potency allows patients who previously used a 1500-IU assay to reduce their potential total administration time by 30% every day.1,2

FVIII Potency VWF Potency Diluent size
250 IU FVIII 300 IU VWF:RCo 5 mL
500 IU FVIII 600 IU VWF:RCo 5 mL
1000 IU FVIII 1200 IU VWF:RCo 10 mL
1500 IU FVIII 1800 IU VWF:RCo 10 mL
2000 IU FVIII 2400 IU VWF:RCo 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


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)3 Koate® Antihemophilic Factor (Human)4
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

Indications

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