What is antihemophilic factor (human)?
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.
Human 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.
Human antihemophilic factor is not for use in people with von Willebrand disease.
Human antihemophilic factor may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking antihemophilic factor (human)?
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 proteins.
Before using human antihemophilic factor, your specific blood clotting disorder must be
diagnosed as factor VIII deficiency. Human 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 human 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.
Human antihemophilic factor 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
human antihemophilic factor.
How should I take antihemophilic factor (human)?
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.
Human 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.
Human 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.
Check your pulse before and during your injection. If your pulse becomes rapid,
slow down or stop the injection until your pulse rate returns to normal.
Human antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days,
depending on the reason you are using the medication. For surgery, you may need use the
medicine for10 to 14 days.
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 appointments.
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 (such as Koate-DVI and Monoclate)
may be stored at room temperature for up to 6 months. 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 of antihemophilic factor (human)?
Human 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 use the medicine at your
next regularly scheduled time.
Do not
use extra medicine to make up the
missed dose.
Where can I get more information about antihemophilic factor (human)?
Your pharmacist has information about antihemophilic factor (human) written for health professionals that you may read.
What are the possible side effects of antihemophilic factor (human)?
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 this medication and 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;
-
fever, chills, drowsiness, and runny nose followed by skin
rash and joint pain 2 weeks later; or
-
nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
-
mild nausea or stomach pain.
-
tingly or jittery feeling;
-
blurred vision;
-
headache; or
-
swelling, stinging, or irritation where the injection was
given.
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.
What is the most important information I should know about antihemophilic factor (human)?
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 proteins.
Before using human 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 appointments.
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.
Human antihemophilic factor 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 avoid while taking antihemophilic factor (human)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity
while you are using human antihemophilic factor.
What other drugs will affect antihemophilic factor (human)?
There may be other drugs not listed that can affect human 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.
What happens if I have an overdose of antihemophilic factor (human)?