Passion For Care

With a patient-centered approach, Grifols believes that all patients should have access to proper medications. With this commitment to care, we offer several options for factor therapy, financial support, and tips for living with and managing your hemophilia A or von Willebrand disease (VWD).

 

About Alphanate

ALPHANATE has a proven natural protection for both hemophilia A and von Willebrand disease1

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

ALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

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.

A Mix2Vial® is standard in every carton for easy reconstitution.View Instructions for Mix2Vial® Reconstitution*

*Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.

ALPHANATE packaging is designed for the unique needs of patients using a high-volume dose of plasma-derived FVIII

Among FVIII/VWF complex products, only ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) offers the convenience of a large 2000 IU vial size with low diluent volume.

The new 2000 IU FVIII ALPHANATE assay is now the largest FVIII and von Willebrand factor:ristocetin cofactor (VWF:RCo) assay available on the market for any plasma-derived FVIII concentrate. The higher potency allows patients who previously used a 1500 IU assay to reduce their potential total administration time by 30% every day.

"I would infuse more often than I currently do because it would take less time."

~ Hemophilia A patient

"Having a 2000 IU vial size would make a difference in me not skipping medication, because the less time it takes to administer the better."

~ Hemophilia A patient

High-volume plasma-derived FVIII product comparison for a hypothetical 60-kg patient requiring a dose of 100 IU/kg (6000 IU)


Factor VIII and von Willebrand factor - a natural combination

People with hemophilia A usually have enough von Willebrand factor (VWF), and most people with von Willebrand disease (VWD) have enough FVIII.

So why give both factors together?

In the body, FVIII and VWF naturally travel together. VWF protects FVIII from agents in the blood that try to destroy it.


FVIII and VWF work together in the clotting process, providing natural protection. Without VWF, FVIII is quickly inactivated by a variety of proteases, or enzymes that breakdown proteins.

Press Play to view how circulating FVIII is quickly inactivated by a variety of proteases when it travels without VWF.

 

Press Play to view how FVIII travels when it is bound to VWF.

  • VWF binds to FVIII and thereby protects it against proteolytic attack by a variety of proteases2,3
  • VWF carries FVIII to the bleeding site where FVIII is cleaved and activated by thrombin4
  • VWF prolongs the half-life of circulating FVIII2
  • VWF binds to a similar epitope on the FVIII molecule as inhibitors directed against the C2 domain5
 

Easy Reconstitution & Administration

Every package of ALPHANATE comes with a Mix2Vial® device for easy reconstitution

Watch the Mix2Vial® reconstitution demo:

 

View Instructions for Mix2Vial® Reconstitution*

*Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.

Administration

ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) 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 the appropriate safety container. Do not administer ALPHANATE at a rate exceeding 10 mL/min.

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.

Grifols Patient Services

If you have questions about ALPHANATE, answers
are just a phone call away. Factors for Health
experts are here to talk to you one-on-one about
about benefits, savings options, and more.

Factors for Health offers:

  • The $0 Copay Assistance Program,
    which covers out-of-pocket expenses not covered or partially covered by insurance

  • The Free Trial Program for eligible
    patients who are new to ALPHANATE

  • Benefits investigation and support
    services to help you coordinate with
    your insurer

  • The Patient Assistance Program
    for patients with no coverage or
    lapsed coverage

  • Care Coordination to help you
    access and stay on ALPHANATE

How to enroll:

Call 844-MY-FACTOR (693-2286)

Monday through Friday, 8:00 AM to 8:00 PM EST

 

 

Patient Resources

Reach out to your local Grifols representative to request educational materials

Find out your local Grifols representative's name and email address by entering your zip code and clicking "Submit"

Zip Code must have 5 numeric digits.

 

Hemophilia and VWD FlashLINK

Hemophilia FlashLINK

von Willebrand Disease FlashLINK

FlashLINK is a valuable resource for additional information related to bleeding disorders. You can request a USB FlashLINK device containing this information at your local hemophilia treatment center (HTC).

 

uPatient Hemophilia

uPatient Hemophilia is a tool designed with the input of Hemophilia Treatment Center nurses to help patients organize and plan the events related to the treatment of their bleeding disorder. It was created for patients with hemophilia A, hemophilia B, and von Willebrand disease.

 

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

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.

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.

Please see full Prescribing Information for ALPHANATE.

 


Reference

  1. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols.
  2. Franchini M, Lippi G. Von Willebrand factor-containing factor VIII concentrates and inhibitors in haemophilia A. A critical literature review. Thromb Haemost. 2010;104:931-940.
  3. Philipp, C. The Aging Patient with Hemophilia: Complications, Comorbidities, and Management Issues. Hematology. 2010; 1:191-196.
  4. Federici AB, Mannucci PM. Management of inherited von Willebrand disease in 2007. Ann Med. 2007;39:346-358.
  5. Lacroix-Desmazes S, Navarrete AM, André S, Bayry J, Kaveri SV, Dasgupta S. Dynamics of factor VIII interactions determine its immunologic fate in hemophilia A. Blood. 2008;112(2):240-249.
  6. Di Minno G, Coppola A. A role for von Willebrand factor in immune tolerance induction in patients with haemophilia A and inhibitors? Blood Transfus. 2011;9(suppl 2):s14-s20.
  7. Humate-P Human Plasma-derived von Willebrand factor (HP-VWF/FVIII) Concentrate Prescribing Information. CSL Behring; 2013.
  8. Anithemophilic Factor (Human) Koate-DVI Prescribing Information. Kedrion Biopharma; 2012.