Generic Name: antihemophilic factor (recombinant) (ant ee hee moe FIL ik FAK tor (ree KOM bin ant))
Brand Name: Advate, Eloctate with Fc Fusion Protein, Helixate FS, Kogenate FS, Recombinate, Xyntha
What is recombinant antihemophilic factor?
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.
Recombinant antihemophilic factor works by temporarily raising levels of factor VIII in the blood to aid in clotting.
Recombinant antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.
Recombinant antihemophilic factor is not for use in people with von Willebrand disease.
Recombinant antihemophilic factor may also be used for purposes not listed in this medication guide.
What is the most important information I should know about recombinant antihemophilic factor?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What should I discuss with my health care provider before using recombinant antihemophilic factor?
You should not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor, or if you are allergic to mouse or beef proteins.
Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Recombinant antihemophilic factor will not treat von Willebrand disease.
It is not known whether recombinant antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I use recombinant antihemophilic factor?
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.
Recombinant antihemophilic factor 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.
Recombinant antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medicine.
This medicine 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.
Recombinant antihemophilic factor 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.
Gently swirl the medicine and diluent to mix them and allow the medicine to completely dissolve.
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.
Prepare your dose in 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 recombinant antihemophilic factor if it has changed colors or has particles in it. Call your pharmacist for new medication.
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 recombinant antihemophilic factor, 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.
Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.
Store the medicine and the diluent in the refrigerator and do not allow them to freeze.
You may also store the medication and diluent at room temperature until the expiration date on the label. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first). Follow the storage directions on the medicine label.
Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.
What happens if I miss a dose?
Since recombinant antihemophilic factor is used 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 recombinant antihemophilic factor?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Recombinant antihemophilic factor 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.
Stop using recombinant antihemophilic factor and call your doctor at once if you have:
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.
Common side effects may include:
nausea, vomiting, diarrhea;
sore throat, cough, stuffy nose;
weakness, feeling tired;
pain, swelling, itching, or irritation where the injection was given.
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 dosing information
Usual Adult Dose for Hemophilia A:
Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested:
Number of AHF I.U. required = (body weight (in kg) x desired Factor VIII increase (% normal)) x 0.5
Dosage necessary to maintain the therapeutic plasma level bases on bleeding episode:
Minor hemorrhage (superficial, early hemorrhages, hemorrhages into joints): Therapeutically necessary plasma level of FVIII activity is 20% to 40% of normal, repeated every 12 to 24 hours as necessary until resolved. (At least 1 day, depending upon the severity of the bleeding episode.)
Moderate (bleeding into muscles, mild head trauma, bleeding into the oral cavity): Therapeutically necessary plasma level of FVIII activity is 30% to 60% of normal, repeated every 12 to 24 hours for 3-4 days or until adequate local hemostasis is achieved.
Major (gastrointestinal bleeding, intracranial, intraabdominal or intrathoracic bleeding, fractures): Therapeutically necessary plasma level of FVIII activity is 60% to 100 % of normal, repeated every 8 to 24 hours until bleeding is resolved, resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.
Usual Pediatric Dose for Hemophilia A:
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes:
Up to 16 years of age: 20 to 40 IU per kg every other day (3 to 4 times weekly). Alternatively, an every third day dosing regimen targeted to maintain Factor VIII trough levels greater than 1% may be employed.
Dosage necessary to maintain the therapeutic plasma level based on an active bleeding episode:
Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested: Number of Antihemophilic Factor IU required = (body weight (in kg) x desired Factor VIII increase (% normal)) x 0.5
Minor hemorrhage (superficial, early hemorrhages, hemorrhages into joints): Therapeutically necessary plasma level of Factor VIII activity is 20% to 40% of normal, repeated every 12 to 24 hours as necessary until resolved. (At least 1 day, depending upon the severity of the bleeding episode.)
Moderate (bleeding into muscles, mild head trauma, bleeding into the oral cavity): Therapeutically necessary plasma level of Antihemophilic Factor VIII activity is 30% to 60% of normal, repeated every 12 to 24 hours for 3-4 days or until adequate local hemostasis is achieved.
Major (gastrointestinal bleeding, intracranial, intra abdominal or intrathoracic bleeding, fractures): Therapeutically necessary plasma level of Antihemophilic Factor VIII activity is 60% to 100 % of normal, repeated every 8 to 24 hours until bleeding is resolved, resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.
What other drugs will affect recombinant antihemophilic factor?
Other drugs may interact with recombinant antihemophilic factor, 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.
More about antihemophilic factor
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- Antihemophilic factor (recombinant) (plasma/albumin free) (advate)
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Where can I get more information?
- Your pharmacist can provide more information about recombinant antihemophilic factor.
- 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: 7.01. Revision Date: 2014-12-10, 2:30:13 PM.