Generic Name: antihemophilic factor (recombinant) (ant ee hee moe FIL ik FAK tor (ree KOM bin ant))Brand Names: Advate rAHF-PFM, Helixate FS, Kogenate FS, Kogenate FS with Bioset, Recombinate, Refacto
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.
This medication 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 other purposes not listed in this medication guide.What is the most important information I should know about recombinant antihemophilic factor?Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, 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. Human antihemophilic factor will not treat von Willebrand disease.
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 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.What should I discuss with my health care provider before using recombinant antihemophilic factor?Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, 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.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 recombinant antihemophilic factor 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.
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. Always check the strength of the medicine on the label to be sure you are using the correct potency.
Recombinant antihemophilic factor 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.
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.
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.
Recombinant antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medication.
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.
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.Carry an ID card or wear a medical alert bracelet stating that you have hemophilia 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 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.
Recombinant antihemophilic factor 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 and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.
Call your doctor if you think you have used too much of this medicine. An overdose of recombinant antihemophilic factor is not expected to produce life-threatening symptoms.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.
Less serious side effects may include:
sore throat, cough, runny nose;
fever or chills;
mild nausea, vomiting;
unusual or unpleasant taste in your mouth;
skin itching or rash;
warmth, redness, itching, or tingling under your skin;
joint pain or swelling;
swelling, stinging, 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.
There may be other drugs that can affect recombinant antihemophilic factor. 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.