Alphanate

Name: Alphanate

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.

How supplied

Dosage Forms And Strengths

ALPHANATE is available as a lyophilized powder for intravenous injection after reconstitution. It is available in the following potencies:

250 IU FVIII/5 mL single dose vial
500 IU FVIII/5 mL single dose vial
1000 IU FVIII/10 mL single dose vial
1500 IU FVIII/10 mL single dose vial
2000 IU FVIII/10 mL single dose vial

ALPHANATE is supplied in sterile, lyophilized form in a single dose vial with a vial of diluents (Sterile Water for Injection, USP) and a Mix2Vial filter transfer set. IU activity of FVIII and VWF:RCo are stated on the carton and label of each vial.

ALPHANATE is available in the following potencies and color coded based upon assay on the carton and label as follows:

Potency NDC Assay Color Code
250 IU FVIII/5 mL single dose vial 68516-4601-1 250 IU FVIII Range - grey box
500 IU FVIII/5 mL single dose vial 68516-4602-1 500 IU FVIII Range - blue box
1000 IU FVIII/10 mL single dose vial 68516-4603-2 1000 IU FVIII Range - red box
1500 IU FVIII/10 mL single dose vial 68516-4604-2 1500 IU FVIII Range - black box
2000 IU FVIII/10 mL single dose vial 68516-4609-2 2000 IU FVIII Range - green box

Storage And Handling

ALPHANATE is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F). Do not freeze.

REFERENCES

1. Srivastava, A., Brewer, A.K., et al. WFH Guidelines: Guidelines for the management of hemophilia. Haemophilia 2013; 19, e1-e47.

2. Kempton, C.L., White, G.C. How we treat a hemophilia A patient with a factor VIII inhibitor. Blood 2009; 113:11-17.

3. Federici, A.B., Baudo, F., Caracciolo, C., Mancuso, G., Mazzucconi, M.G., Musso, R., Schinco, P.C., Targhetta. R., Mannucci, P.M. Clinical efficacy of highly purified, doubly virus-inactivated factor VIII/von Willebrand factor concentrate (Fanhdi) in the treatment of von Willebrand disease: a retrospective clinical study. Haemophilia 2002; 8:761-767.

4. Federici, A.B. Management of von Willebrand disease with factor VIII/von Willebrand factor concentrates: results from current studies and surveys. Blood Coagul Fibrinolysis 2005; 16(Suppl 1):S17-S21.

5. Mannucci, P.M. How I treat patients with von Willebrand disease. Blood 2001; 97:1915-1919.

6. Mannucci, P.M. Treatment of von Willebrand's Disease. N Engl J Med 2004; 351:47-58.

7. Nichols, W.L. et al.; NHLBI VWD Expert Panel. The Diagnosis, Evaluation, and Management of von Willebrand Disease. US Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute 2007; NIH No. 08-5832.

8. Mannucci, P.M., Franchini, M., Castaman, G., Federici, A.B.; Italian Association of Haemophilia Centres. Evidence-based recommendations on the treatment of von Willebrand disease in Italy. Blood Transfus 2009; 7:117-126.

Manufactured by: Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA 90032, U.S.A. Revised: Mar 2015

How should I use antihemophilic and von Willebrand factor complex?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Antihemophilic and von Willebrand factor complex is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Antihemophilic and von Willebrand factor complex is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing the medicine with a diluent, store at room temperature and use it within 3 hours. Do not refrigerate or freeze.

Do not shake the mixed medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. A single-use vial is for one use only. After measuring your dose, throw this vial away, even if there is medicine left in it.

Do not use antihemophilic and von Willebrand factor complex if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using this medicine, you may need frequent blood tests.

Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Carefully follow all instructions about how to store this medicine. Each brand of antihemophilic and von Willebrand factor complex may have specific storage instructions.

Store the medicine and diluent at room temperature, away from moisture and heat. Throw away any medicine not used before the expiration date on the medicine label.

The Wilate brand of this medicine should be stored in the original container in the refrigerator. Do not freeze. Before preparing your dose, take these items of the refrigerator and allow them to reach room temperature.

If you store this medicine at room temperature, do not return it to the refrigerator.

Wear a medical alert tag or carry an ID card stating that you have hemophilia or von Willebrand disease. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Uses of Alphanate

  • It is used to treat von Willebrand disease.
  • It is used to treat or prevent bleeding.
  • Some products are used to treat hemophilia. Talk with the doctor.
  • It may be given to you for other reasons. Talk with the doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Alphanate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Alphanate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Contraindications

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

How Supplied/Storage and Handling

Alphanate is supplied in sterile, lyophilized form in a single dose vial with a vial of diluent (Sterile Water for Injection, USP) and a Mix2Vial filter transfer set. IU activity of FVIII and VWF:RCo are stated on the carton and label of each vial. Alphanate is available in the following potencies and color coded based upon assay on the carton and label as follows:

 Potency  NDC  Assay Color Code
 250 IU FVIII/5 mL single dose vial  68516-4601-1  250 IU FVIII Range - grey box
 500 IU FVIII/5 mL single dose vial  68516-4602-1  500 IU FVIII Range - blue box
1000 IU FVIII/10 mL single dose vial  68516-4603-2  1000 IU FVIII Range - red box
1500 IU FVIII/10 mL single dose vial  68516-4604-2  1500 IU FVIII Range - black box

Storage

  • Store under refrigeration at temperatures between 2 and 8 °C (34 to 46 °F). Do not freeze to prevent damage to diluent vial.
  • May be stored at room temperature not to exceed 30 ºC for up to 2 months. If stored outside the refrigerator, record the date removed on the space provided on the carton.
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