antihemophilic factor-von Willebrand factor complex

Generic Name: antihemophilic and von Willebrand factor complex (AN tye HEE moe FIL ik and von WIL e brand FAK tor KOM plex)
Brand Name: Alphanate, Humate-P, Wilstart, Dried Factor VIII Fraction Type 8Y, Haemate P, Optivate, Wilate

What is antihemophilic and von Willebrand factor complex?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot.

A lack of antihemophilic factor VIII is the cause of hemophilia A. A lack of an antihemophilic factor called von Willebrand factor is the cause of von Willebrand disease. This medication works by temporarily raising levels of factor VIII or von Willebrand factor in the blood to aid in clotting.

Antihemophilic and von Willebrand factor complex is a combination medicine used to treat or prevent bleeding episodes in adults with hemophilia A.

Antihemophilic factor is also used to treat or prevent bleeding episodes in adults and children with von Willebrand disease.

Antihemophilic and von Willebrand factor complex may also be used for purposes not listed in this medication guide.

What is the most important information I should know about antihemophilic and von Willebrand factor complex?

You should not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

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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.

What should I discuss with my health care provider before using antihemophilic and von Willebrand factor complex?

You should not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

To make sure you can safely use this medication, tell your doctor if you have ever had a stroke or a blood clot.

FDA pregnancy category C. It is not known whether antihemophilic and von Willebrand factor complex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether antihemophilic and von Willebrand factor complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Antihemophilic and von Willebrand factor complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Your doctor may want you to receive a hepatitis vaccination before you start using antihemophilic and von Willebrand factor complex.

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.

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 self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. 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.

You may gently swirl the medicine and diluent to mix them, but do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

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.

While using antihemophilic and von Willebrand factor complex, you may need frequent blood tests at your doctor's office.

Store the medication and diluent at room temperature, away from moisture and heat. After mixing the medicine with a diluent, store at room temperature and use it within 3 hours. Do not refrigerate or freeze. Throw away any medicine not used before the expiration date on the medicine label.

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

What happens if I miss a dose?

Since this medicine is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while using antihemophilic and von Willebrand factor complex?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Antihemophilic and von Willebrand factor complex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest tightness, wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • hot flashes when the injection is given;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • low fever with skin rash, and joint pain, swelling, or stiffness;

  • bleeding from a wound or where the medicine was injected; or

  • bleeding that is not controlled.

Common side effects may include:

  • tired feeling;

  • mild rash or itching;

  • pain, headache;

  • numbness or tingling;

  • nausea; or

  • anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Antihemophilic factor-von Willebrand factor complex dosing information

Usual Adult Dose for Hemophilia A:

Minor hemorrhage (early joint or muscle bleed or severe epistaxis): Loading dose 15 IU FVIII/kg to achieve FVIII plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the loading dose may be given once or twice daily for 1 to 2 days.

Moderate hemorrhage (advanced joint or muscle bleed, neck, tongue or pharyngeal hematoma (without airway compromise), tooth extraction, or severe abdominal pain): Loading dose 25 IU FVIII/kg to achieve FVIII plasma level of approximately 50% of normal, followed by 15 IU FVIII/kg every 8 to 12 hours for first 1 to 2 days to maintain FVIII plasma level at 30% of normal, and then the same dose once or twice a day for a total of up to 7 days, or until adequate wound healing.

Life-threatening hemorrhage (major operations, gastrointestinal bleeding, neck, tongue or pharyngeal hematoma with potential for airway compromise, intracranial, intraabdominal or intrathoracic bleeding, or fractures): Initially 40 to 50 IU FVIII/kg, followed by 20 to 25 IU FVIII/kg every 8 hours to maintain FVIII plasma level at 80 to 100% of normal for 7 days, then continue the same dose once or twice a day for another 7 days in order to maintain the FVIII level at 30 to 50% of normal.

Usual Pediatric Dose for von Willebrand's Disease:

Treatment of von Willebrand Disease:
Type 1 mild, if desmopressin is inappropriate (Baseline von Willebrand factor (VWF) activity typically greater than 30%):
Major Hemorrhage (e.g. severe or refractory epistaxis, GI bleeding, CNS trauma, or traumatic hemorrhage): Loading dose 40 to 60 IU/kg, then 40 to 50 IU/kg every 8 to 12 hours for 3 days to keep the trough level of VWF greater than 50%; then 40 to 50 IU/kg daily for a total of up to 7 days of treatment.
Type 1 moderate or severe (Baseline VWF activity typically less than 30%):
Minor (e.g. epistaxis, oral bleeding, menorrhagia): 40 to 50 IU/kg (1 or 2 doses)
Major (e.g. severe or refractory epistaxis, GI bleeding, CNS trauma, hemarthrosis or traumatic hemorrhage): Loading dose 50 to 75 IU/kg, then 40 to 60 IU/kg every 8 to 12 hours for 3 days to keep the trough level of VWF greater than 50%; then 40 to 60 IU/kg daily for a total of up to 7 days of treatment. Factor VIII levels should be monitored and maintained according to the guidelines for hemophilia A therapy.
Types 2 (all variants) and 3:
Minor (clinical indications above): 40 to 50 IU/kg (1 or 2 doses).
Major (clinical indications above): Loading dose of 60 to 80 IU/kg, then 40 to 60 IU/kg every 8 to 12 hours for 3 days to keep the trough level of VWF greater than 50%; then 40 to 60 IU/kg daily for a total of up to 7 days of treatment. Factor VIII levels should be monitored and maintained according to the guidelines for hemophilia A therapy.

In the case of emergency surgery, administer a loading dose of 50 to 60 IU/kg and, subsequently, closely monitor the trough coagulation factor levels.

Prevention of Excessive Bleeding During and After Surgery in VWD:
When possible, it is recommended that the incremental in vivo recovery (IVR) be measured and that baseline plasma VWF and FVIII be assessed in all patients prior to surgery. Measure IVR as follows:
1. Measure baseline plasma VWF.
2. Infuse 60 IU VWF/kg product intravenously at time 0.
3. At time +30 minutes, measure plasma VWF.
IVR = (Plasma VWF at time +30 min - Plasma VWF at baseline) / 60 IU kg.

Calculation of the loading dose requires four values: the target peak plasma VWF level, the baseline VWF level, body weight (BW) in kilograms, and IVR. When individual recovery values are not available, a standardized loading dose can be used based on an assumed VWF IVR of 2.0 IU/dL per IU/kg of VWF product administered.

Major Surgery: VWF Target Peak Plasma Level is 100 IU/dL and FVIII Target Peak Plasma Level is 80 to 100 IU/dL.
Calculation of Loading Dose (to be administered 1 to 2 hours before surgery): (Target peak plasma VWF - baseline plasma VWF x BW (kg) / IVR = IU VWF required.
If the incremental IVR is not available, assume an IVR of 2 IU/dL per IU/kg and calculate the loading dose as follows: (100 - baseline plasma VWF) x BW (kg) / 2.
Minor surgery VWF Target Peak Plasma Level is 50 to 60 IU/dL and FVIII Target Peak Plasma Level is 40 to 50 IU/dL.
Calculation of Loading Dose (to be administered 1 to 2 hours before surgery): (Target peak plasma VWF - baseline plasma VWF x BW (kg) / IVR = IU VWF required.

Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery:
Major surgery: VWF target level is greater than 50 IU/dL up to 3 days following surgery and greater than 30 IU/dL after day 3. FVIII target trough plasma level is greater than 50 IU/dL up to 3 days following surgery and greater than 30 IU/dL after day three. The minimum duration of treatment is 72 hours.
Minor surgery: VWF target level is greater than or equal to 30 IU/dL up to 3 days following surgery. FVIII target trough plasma level is greater 30 IU/dL after day three. The minimum duration of treatment is 48 hours.
Oral Surgery: VWF target level is greater than 30 IU/dL up to 3 days following surgery. FVIII target trough plasma level is greater than or equal to 30 IU/dL after day three. The minimum duration of treatment is 8 to 12 hours.

Usual Pediatric Dose for Hemophilia A:

Adequate and well-controlled studies with long-term evaluation of joint damage have not been done in pediatric subjects. Joint damage may result from suboptimal treatment of hemarthroses. For immediate control of bleeding for Hemophilia A, the general recommendations for dosing and administration for adults, as follows, may be referenced.

Minor hemorrhage (early joint or muscle bleed or severe epistaxis): Loading dose 15 IU FVIII/kg to achieve FVIII plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the loading dose may be given once or twice daily for 1 to 2 days.

Moderate hemorrhage (advanced joint or muscle bleed, neck, tongue or pharyngeal hematoma (without airway compromise), tooth extraction, or severe abdominal pain): Loading dose 25 IU FVIII/kg to achieve FVIII plasma level of approximately 50% of normal, followed by 15 IU FVIII/kg every 8 to 12 hours for first 1 to 2 days to maintain FVIII plasma level at 30% of normal, and then the same dose once or twice a day for a total of up to 7 days, or until adequate wound healing.

Life-threatening hemorrhage (major operations, gastrointestinal bleeding, neck, tongue or pharyngeal hematoma with potential for airway compromise, intracranial, intraabdominal or intrathoracic bleeding, or fractures): Initially 40 to 50 IU FVIII/kg, followed by 20 to 25 IU FVIII/kg every 8 hours to maintain FVIII plasma level at 80 to 100% of normal for 7 days, then continue the same dose once or twice a day for another 7 days in order to maintain the FVIII level at 30 to 50% of normal.

What other drugs will affect antihemophilic and von Willebrand factor complex?

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about antihemophilic and von Willebrand factor complex.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2013-11-20, 10:44:33 AM.

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