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Drugs reference index «antihemophilic factor-von Willebrand factor complex»

antihemophilic factor-von Willebrand factor complex

Generic Name: antihemophilic factor-von Willebrand factor complex (an tee hee moe FIL ik FAK tor - von WIL e brand FAK tor)Brand names: Humate-P, Wilstart, Dried Factor VIII Fraction Type 8Y, Haemate P, Optivate, Alphanate

What is antihemophilic factor-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 factor-von Willebrand factor complex is used to treat or prevent bleeding episodes in adults with hemophilia A. It is also used to treat injury-related bleeding episodes in adults and children with von Willebrand disease.

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

What is the most important information I should know about antihemophilic factor-von Willebrand factor complex?Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

Before using antihemophilic factor-von Willebrand factor complex, tell your doctor if you have ever had a stroke or a blood clot.

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

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia or von Willebrand disease in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

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

What should I discuss with my health care provider before using antihemophilic factor-von Willebrand factor complex?Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

Before using antihemophilic factor-von Willebrand factor complex, tell your doctor if you have ever had a stroke or a blood clot.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether antihemophilic factor-von Willebrand factor complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Antihemophilic factor-von Willebrand factor complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, 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 factor-von Willebrand factor complex.

How should I use antihemophilic factor-von Willebrand factor complex?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Antihemophilic factor-von Willebrand factor complex is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving 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 factor-von Willebrand factor complex must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to reach room temperature before mixing them.

You may gently swirl the medicine and diluent to mix them, but do not shake the vial (bottle). Vigorous shaking can ruin the medicine. After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Draw your dose into a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use this medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles 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.

Antihemophilic factor-von Willebrand factor complex is usually given every 8 to 12 hours for up to 7 days, depending on the reason you are using the medication.

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.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia or von Willebrand disease in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and diluent at room temperature, away from moisture and heat. Avoid freezing.

Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Antihemophilic factor-von Willebrand factor complex is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Call your doctor if you think you have used too much of this medicine. An overdose of antihemophilic factor-von Willebrand complex is not expected to produce life-threatening symptoms.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

Antihemophilic factor-von Willebrand factor complex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
  • easy bruising, increased bleeding episodes;

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

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

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds; or

  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • nausea, constipation;

  • swelling, stinging, or irritation where the injection was given;

  • skin rash or itching;

  • swelling in your hands or feet;

  • pain in your arms or legs;

  • chills; or

  • dizziness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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) \tMajor (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.\tTypes 2 (all variants) and 3:Minor (clinical indications above): 40 to 50 IU/kg (1 or 2 doses).\tMajor (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.\tIn 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.\tMinor 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 \tminimum duration of treatment is 72 hours. \tMinor 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 factor-von Willebrand factor complex?

There may be other drugs that can interact with antihemophilic factor-von Willebrand factor complex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about antihemophilic factor-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.
  • 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 1996-2006 Cerner Multum, Inc. Version: 1.06. Revision Date: 4/12/2009 4:46:09 PM.

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