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antihemophilic and 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.

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 and von Willebrand factor complex dosing information

Usual Adult Dose for Hemophilia A:

ALPHANATE(R):
Minor Hemorrhage (large bruises, significant cuts or scrapes, uncomplicated joint hemorrhage):
15 international units factor VIII (FVIII)/kg IV every 12 hours to achieve FVIII plasma level of 30% of normal, until hemorrhage stops and healing has been achieved (1 to 2 days)

Moderate Hemorrhage (nose, mouth, and gum bleeds; dental extractions; hematuria):
25 international units FVIII/kg IV every 12 hours to achieve FVIII plasma level of 50% of normal, until healing has been achieved (2 to 7 days, on average)

Major Hemorrhage (joint hemorrhage, muscle hemorrhage, major trauma, hematuria, intracranial and intraperitoneal bleeding):
-Initial dose: 40 to 50 international units FVIII/kg IV every 12 hours to achieve FVIII plasma level of 80% to 100% of normal, for at least 3 to 5 days
-Maintenance dose: 25 international units FVIII/kg IV every 12 hours to maintain FVIII plasma level at 80% to 100% of normal, until healing has been achieved for up to 10 days; intracranial hemorrhage may require prophylaxis therapy for up to 6 months

Surgery:
-Pre-surgery: 40 to 50 international units FVIII/kg IV once to achieve FVIII plasma level of 80% to 100% of normal
-Post-surgery: 30 to 50 international units FVIII/kg IV every 12 hours to maintain FVIII plasma level at 60% to 100% of normal, for the next 7 to 10 days or until healing has been achieved

HUMATE-P(R):
Minor Hemorrhage (early joint or muscle bleed or severe epistaxis):
15 international units FVIII/kg IV to achieve FVIII plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the initial dose may be given once or twice a day for 1 to 2 days.

Moderate Hemorrhage (advanced joint or muscle bleed; neck, tongue, or pharyngeal hematoma without airway compromise; tooth extraction; severe abdominal pain):
-Loading dose: 25 international units FVIII/kg IV to achieve FVIII plasma level of approximately 50% of normal
-Maintenance dose: 15 international units FVIII/kg IV 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 up to 7 days, or until adequate wound healing.

Life-Threatening Hemorrhage (major surgery; gastrointestinal bleeding; neck, tongue, or pharyngeal hematoma with potential for airway compromise; intracranial, intraabdominal, or intrathoracic bleeding; fractures):
-Initial dose: 40 to 50 international units FVIII/kg IV
-Maintenance dose: 20 to 25 international units 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 FVIII plasma level at 30% to 50% of normal.

Usual Adult Dose for von Willebrand's Disease:

TREATMENT OF BLEEDING EPISODES IN VON WILLEBRAND DISEASE (VWD):

HUMATE-P(R):
Type 1, Mild VWD (baseline von Willebrand factor:ristocetin cofactor activity [VWF:RCo] typically greater than 30%):
Minor hemorrhage (if desmopressin is inappropriate) or major hemorrhage (e.g., severe or refractory epistaxis, gastrointestinal [GI] bleeding, central nervous system [CNS] trauma, traumatic hemorrhage):
-Loading dose: 40 to 60 international units VWF:RCo/kg IV
-Maintenance dose: 40 to 50 international units VWF:RCo/kg IV every 8 to 12 hours for 3 days to keep VWF:RCo trough greater than 50%; then 40 to 50 international units VWF:RCo/kg IV daily for up to 7 days
-Comments: Monitor and maintain factor VIII (FVIII) levels according to hemophilia A guidelines for major bleeds.

Type 1, Moderate or Severe VWD (baseline VWF:RCo typically less than 30%):
Minor hemorrhage (e.g., epistaxis, oral bleeding, menorrhagia): 40 to 50 international units VWF:RCo/kg IV (1 or 2 doses)
Major hemorrhage (e.g., severe or refractory epistaxis, GI bleeding, CNS trauma, hemarthrosis, traumatic hemorrhage):
-Loading dose: 50 to 75 international units VWF:RCo/kg IV
-Maintenance dose: 40 to 60 international units VWF:RCo/kg IV every 8 to 12 hours for 3 days to keep VWF:RCo trough greater than 50%; then 40 to 60 international units VWF:RCo/kg IV daily for up to 7 days
-Comments: Monitor and maintain FVIII levels according to hemophilia A guidelines for major bleeds.

Types 2 (all variants) and 3 VWD:
Minor hemorrhage (clinical indications above): 40 to 50 international units VWF:RCo/kg IV (1 or 2 doses).
Major hemorrhage (clinical indications above):
-Loading dose: 60 to 80 international units VWF:RCo/kg IV
-Maintenance dose: 40 to 60 international units VWF:RCo/kg IV every 8 to 12 hours for 3 days to keep VWF:RCo trough greater than 50%; then 40 to 60 international units VWF:RCo/kg IV daily for up to 7 days
-Comments: Monitor and maintain FVIII levels according to hemophilia A guidelines for major bleeds.

WILATE(R):
Minor Hemorrhage:
Loading dose: 20 to 40 international units VWF:RCo/kg IV
Maintenance dose: 20 to 30 international units VWF:RCo/kg IV every 12 to 24 hours for up to 3 days, keeping VWF:RCo and FVIII troughs greater than 30%
Comments: In VWD type 3 patients, especially those with GI bleeding, higher doses may be required.

Major Hemorrhage:
Loading dose: 40 to 60 international units VWF:RCo/kg IV
Maintenance dose: 20 to 40 international units VWF:RCo/kg IV every 12 to 24 hours for 5 to 7 days, keeping VWF:RCo and FVIII troughs greater than 50%
Comments: In VWD type 3 patients, especially those with GI bleeding, higher doses may be required.


PREVENTION OF EXCESSIVE BLEEDING DURING AND AFTER SURGERY IN VWD:

ALPHANATE(R):
Minor and Major Surgery/Bleeding (except type 3 VWD patients undergoing major surgery):
Preoperative dose: 60 international units VWF:RCo/kg IV
-Minor surgery/bleeding target FVIII coagulant activity (FVIII:C) levels: 40 to 50 international units/dL
-Major surgery/bleeding target FVIII:C levels: 100 international units/dL

Maintenance dose:
-Minor: 40 to 60 international units VWF:RCo/kg IV every 8 to 12 hours as needed to maintain FVIII:C of 40 to 50 international units/dL, for 1 to 3 days
-Major: 40 to 60 international units VWF:RCo/kg IV every 8 to 12 hours as needed to maintain FVIII:C of 100 international units/dL, for at least 3 to 7 days

Comments:
-Monitor peak and trough VWF:RCo and FVIII:C at least daily.
-VWF:RCo and FVIII:C troughs should remain above 50 international units/dL.
-VWF:RCo and FVIII:C should not exceed 150 international units/dL.

HUMATE-P(R):
Emergency Surgery:
Loading dose: 50 to 60 international units VWF:RCo/kg IV to achieve VWF:RCo of 100 international units/dL and FVIII:C of 80 to 100 international units/dL

Comments: Closely monitor trough coagulation factor levels.

Nonemergency Surgery:
Loading dose calculation (to be administered 1 to 2 hours before surgery): (Target peak VWF:RCo - baseline VWF:RCo) x body weight (kg) / in vivo recovery (IVR) = international units VWF:RCo required. If IVR is not available, assume an IVR of 2 international units/dL per international unit/kg of VWF:RCo administered.

IVR calculation:
1. Measure baseline VWF:RCo.
2. Infuse a calculated dose of VWF:RCo at time 0.
3. At time + 30 minutes, measure VWF:RCo. IVR = (VWF:RCo at time + 30 min - VWF:RCo at baseline) / calculated dose (international units/kg).

Loading dose peak targets:
-Minor/oral surgery: VWF:RCo: 50 to 60 international units/dL; FVIII:C: 40 to 50 international units/dL
-Major surgery: VWF:RCo: 100 international units/dL; FVIII:C: 80 to 100 international units/dL

Maintenance dose: Half the initial loading dose IV generally every 8 or 12 hours (patients with shorter half-lives may require every 6 hours); subsequent dosing should be based on VWF:RCo and FVIII levels
-Oral surgery: Minimum duration of treatment: 8 to 12 hours; VWF:RCo target trough: 30 international units/dL or greater up to 3 days following surgery; FVIII:C target trough: Greater than 30 international units/dL after day 3
-Minor surgery: Minimum duration of treatment: 48 hours; VWF:RCo target trough: 30 international units/dL or greater up to 3 days following surgery; FVIII:C target trough: Greater than 30 international units/dL after day 3
-Major surgery: Minimum duration of treatment: 72 hours; VWF:RCo target trough: Greater than 50 international units/dL up to 3 days following surgery and greater than 30 international units/dL after day 3; FVIII:C target trough: Greater than 50 international units/dL up to 3 days following surgery and greater than 30 international units/dL after day 3

Comments:
-Loading dose peak targets may require additional dosing.
-In the absence of pharmacokinetic data, administer every 8 hours.
-Maximum trough levels should not exceed 100 international units/dL.
-Oral surgery is defined as extraction of fewer than 3 teeth, if the teeth are non-molars and have no bony involvement. Extraction of more than 1 impacted wisdom tooth is considered major surgery. Extraction of more than 2 teeth is considered major surgery in all patients.
-Administer at least 1 maintenance dose following oral surgery based on individual pharmacokinetic values. Subsequent therapy with an antifibrinolytic agent is usually administered until adequate healing is achieved.

Usual Pediatric Dose for Hemophilia A:

ALPHANATE(R):
Minor Hemorrhage (large bruises, significant cuts or scrapes, uncomplicated joint hemorrhage):
15 international units factor VIII (FVIII)/kg IV every 12 hours to achieve FVIII plasma level of 30% of normal, until hemorrhage stops and healing has been achieved (1 to 2 days)

Moderate Hemorrhage (nose, mouth, and gum bleeds; dental extractions; hematuria):
25 international units FVIII/kg IV every 12 hours to achieve FVIII plasma level of 50% of normal, until healing has been achieved (2 to 7 days, on average)

Major Hemorrhage (joint hemorrhage, muscle hemorrhage, major trauma, hematuria, intracranial and intraperitoneal bleeding):
-Initial dose: 40 to 50 international units FVIII/kg IV every 12 hours to achieve FVIII plasma level of 80% to 100% of normal, for at least 3 to 5 days
-Maintenance dose: 25 international units FVIII/kg IV every 12 hours to maintain FVIII plasma level at 80% to 100% of normal, until healing has been achieved for up to 10 days; intracranial hemorrhage may require prophylaxis therapy for up to 6 months

Surgery:
-Pre-surgery: 40 to 50 international units FVIII/kg IV once to achieve FVIII plasma level of 80% to 100% of normal
-Post-surgery: 30 to 50 international units FVIII/kg IV every 12 hours to maintain FVIII plasma level at 60% to 100% of normal, for the next 7 to 10 days or until healing has been achieved

Usual Pediatric Dose for von Willebrand's Disease:

TREATMENT OF BLEEDING EPISODES IN VON WILLEBRAND DISEASE (VWD):

HUMATE-P(R):
Type 1, Mild VWD (baseline von Willebrand factor:ristocetin cofactor activity [VWF:RCo] typically greater than 30%):
Minor hemorrhage (if desmopressin is inappropriate) or major hemorrhage (e.g., severe or refractory epistaxis, gastrointestinal [GI] bleeding, central nervous system [CNS] trauma, traumatic hemorrhage):
-Loading dose: 40 to 60 international units VWF:RCo/kg IV
-Maintenance dose: 40 to 50 international units VWF:RCo/kg IV every 8 to 12 hours for 3 days to keep VWF:RCo trough greater than 50%; then 40 to 50 international units VWF:RCo/kg IV daily for up to 7 days
-Comments: Monitor and maintain factor VIII (FVIII) levels according to hemophilia A guidelines for major bleeds.

Type 1, Moderate or Severe VWD (baseline VWF:RCo typically less than 30%):
Minor hemorrhage (e.g., epistaxis, oral bleeding, menorrhagia): 40 to 50 international units VWF:RCo/kg IV (1 or 2 doses)
Major hemorrhage (e.g., severe or refractory epistaxis, GI bleeding, CNS trauma, hemarthrosis, traumatic hemorrhage):
-Loading dose: 50 to 75 international units VWF:RCo/kg IV
-Maintenance dose: 40 to 60 international units VWF:RCo/kg IV every 8 to 12 hours for 3 days to keep VWF:RCo trough greater than 50%; then 40 to 60 international units VWF:RCo/kg IV daily for up to 7 days
-Comments: Monitor and maintain FVIII levels according to hemophilia A guidelines for major bleeds.

Types 2 (all variants) and 3 VWD:
Minor hemorrhage (clinical indications above): 40 to 50 international units VWF:RCo/kg IV (1 or 2 doses).
Major hemorrhage (clinical indications above):
-Loading dose: 60 to 80 international units VWF:RCo/kg IV
-Maintenance dose: 40 to 60 international units VWF:RCo/kg IV every 8 to 12 hours for 3 days to keep VWF:RCo trough greater than 50%; then 40 to 60 international units VWF:RCo/kg IV daily for up to 7 days
-Comments: Monitor and maintain FVIII levels according to hemophilia A guidelines for major bleeds.

WILATE(R):
Minor Hemorrhage:
Loading dose: 20 to 40 international units VWF:RCo/kg IV
Maintenance dose: 20 to 30 international units VWF:RCo/kg IV every 12 to 24 hours for up to 3 days, keeping VWF:RCo and FVIII troughs greater than 30%
Comments: In VWD type 3 patients, especially those with GI bleeding, higher doses may be required.

Major Hemorrhage:
Loading dose: 40 to 60 international units VWF:RCo/kg IV
Maintenance dose: 20 to 40 international units VWF:RCo/kg IV every 12 to 24 hours for 5 to 7 days, keeping VWF:RCo and FVIII troughs greater than 50%
Comments: In VWD type 3 patients, especially those with GI bleeding, higher doses may be required.


PREVENTION OF EXCESSIVE BLEEDING DURING AND AFTER SURGERY IN VWD:

ALPHANATE(R):
Minor and Major Surgery/Bleeding (except type 3 VWD patients undergoing major surgery):
Preoperative dose: 75 international units VWF:RCo/kg IV
-Minor surgery/bleeding target FVIII coagulant activity (FVIII:C) levels: 40 to 50 international units/dL
-Major surgery/bleeding target FVIII:C levels: 100 international units/dL

Maintenance dose:
-Minor: 50 to 75 international units VWF:RCo/kg IV every 8 to 12 hours as needed to maintain FVIII:C of 40 to 50 international units/dL, for 1 to 3 days
-Major: 50 to 75 international units VWF:RCo/kg IV every 8 to 12 hours as needed to maintain FVIII:C of 100 international units/dL, for at least 3 to 7 days

Comments:
-Monitor peak and trough VWF:RCo and FVIII:C at least daily.
-VWF:RCo and FVIII:C troughs should remain above 50 international units/dL.
-VWF:RCo and FVIII:C should not exceed 150 international units/dL.

HUMATE-P(R):
Emergency Surgery:
Loading dose: 50 to 60 international units VWF:RCo/kg IV to achieve VWF:RCo of 100 international units/dL and FVIII:C of 80 to 100 international units/dL

Comments: Closely monitor trough coagulation factor levels.

Nonemergency Surgery:
Loading dose calculation (to be administered 1 to 2 hours before surgery): (Target peak VWF:RCo - baseline VWF:RCo) x body weight (kg) / in vivo recovery (IVR) = international units VWF:RCo required. If IVR is not available, assume an IVR of 2 international units/dL per international unit/kg of VWF:RCo administered.

IVR calculation:
1. Measure baseline VWF:RCo.
2. Infuse a calculated dose of VWF:RCo at time 0.
3. At time + 30 minutes, measure VWF:RCo. IVR = (VWF:RCo at time + 30 min - VWF:RCo at baseline) / calculated dose (international units/kg).

Loading dose peak targets:
-Minor/oral surgery: VWF:RCo: 50 to 60 international units/dL; FVIII:C: 40 to 50 international units/dL
-Major surgery: VWF:RCo: 100 international units/dL; FVIII:C: 80 to 100 international units/dL

Maintenance dose: Half the initial loading dose IV generally every 8 or 12 hours (patients with shorter half-lives may require every 6 hours); subsequent dosing should be based on VWF:RCo and FVIII levels
-Oral surgery: Minimum duration of treatment: 8 to 12 hours; VWF:RCo target trough: 30 international units/dL or greater up to 3 days following surgery; FVIII:C target trough: Greater than 30 international units/dL after day 3
-Minor surgery: Minimum duration of treatment: 48 hours; VWF:RCo target trough: 30 international units/dL or greater up to 3 days following surgery; FVIII:C target trough: Greater than 30 international units/dL after day 3
-Major surgery: Minimum duration of treatment: 72 hours; VWF:RCo target trough: Greater than 50 international units/dL up to 3 days following surgery and greater than 30 international units/dL after day 3; FVIII:C target trough: Greater than 50 international units/dL up to 3 days following surgery and greater than 30 international units/dL after day 3

Comments:
-Loading dose peak targets may require additional dosing.
-In the absence of pharmacokinetic data, administer every 8 hours.
-Maximum trough levels should not exceed 100 international units/dL.
-Oral surgery is defined as extraction of fewer than 3 teeth, if the teeth are non-molars and have no bony involvement. Extraction of more than 1 impacted wisdom tooth is considered major surgery. Extraction of more than 2 teeth is considered major surgery in all patients.
-Administer at least 1 maintenance dose following oral surgery based on individual pharmacokinetic values. Subsequent therapy with an antifibrinolytic agent is usually administered until adequate healing is achieved.

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

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