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ALPHANATE
provides natural
protection through its
FVIII/VWF complex

For your patients requiring
treatment for hemophilia A
or von Willebrand disease

The natural FVIII/VWF complex in
ALPHANATE is carefully preserved during
the production process.1  ALPHANATE is indicated for:
- Control and prevention of bleeding in adult and pediatric patients with hemophilia A.
- Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease 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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Alphanate packaging

ALPHANATE packaging is
designed with the unique needs
of your high-volume FVIII
users in mind1

ALPHANATE is the only FVIII/VWF complex to offer the convenience of a large 2000-IU vial size with low diluent volume.1

Intravascular hemolysis may occur with large doses of FVIII/VWF complex (human).

Learn more

Alphanate packaging

ALPHANATE packaging is
designed with the unique needs
of your high-volume FVIII
users in mind1

ALPHANATE is the only FVIII/VWF complex to offer the convenience of a large 2000-IU vial size with low diluent volume.1

Learn more

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Safety is our top priority—since product launch in 1997, there has never been a confirmed case of virus or prion transmission with ALPHANATE

The ALPHANATE manufacturing process includes 10 steps to safety, with full traceability from donor to patient.

Alphanate 10 steps to safety infographic
Alphanate 10 steps to safety infographic
Alphanate 10 steps to safety infographic

CGMP, Current Good Manufacturing Practice

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.

 

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Support and resources for patients

 
Alphanate Factors for Health Program

Factors for Health

A comprehensive patient support and assistance program for ALPHANATE patients.

 

 
Alphanate Managing Bleeding Disorders

Tips for living with and managing bleeding disorders

Helpful information and resources you can provide to your patients that may help make living with bleeding disorders a little easier.

 

 
Grifols Gear Travel Kit

Grifols Gear travel kit

This comprehensive travel kit will make traveling easier for your patients with bleeding disorders.

 

 

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FVIII,factor VIII; VWF,von Willebrand factor.


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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Reference:

  1. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols.