What is factor IX complex?
Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A
lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.
Factor IX complex is a combination of four different clotting factors and other proteins.
This medication works by temporarily raising levels of these clotting factors in the blood to aid in
clotting.
Factor IX complex is used to
treat or prevent
bleeding episodes in
people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in
people with hemophilia B.
Factor IX may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking factor IX complex?
Before using factor IX complex, your specific blood clotting disorder must be diagnosed
as factor IX or factor VIII (eight) deficiency.
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 factor IX 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.
Factor IX 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
factor IX complex.
How should I take factor IX 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. Always check the strength of the medicine on the label to be sure you
are using the correct potency.
Factor IX 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.
Always wash your hands before preparing and giving your injection.
Factor IX 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 warm to room temperature before mixing them. Do not heat the medicine or
diluent.
After mixing, gently swirl the mixture 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.
Check your pulse before and during your injection. If your pulse rate changes, slow
or stop the injection until your pulse rate returns to normal.
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.
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.
Throw away any leftover medicine and diluent if the expiration date has passed.
What happens if I miss a dose of factor IX complex?
Factor IX 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.
Where can I get more information about factor IX complex?
Your pharmacist has information about factor IX complex written for health professionals that you may read.
What are the possible side effects of factor IX complex?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; nausea, vomiting; 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:
-
cough, chest pain;
-
weak or shallow breathing;
-
feeling short of breath;
-
headache, feeling like you might pass out;
-
fever, chills, drowsiness, and runny nose followed by skin
rash and joint pain 2 weeks later;
-
nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
easy bruising, increased bleeding episodes; or
-
bleeding from a wound or where the medicine was injected.
Less serious side effects may include:
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 factor IX complex?
Before using factor IX complex, your specific blood clotting disorder must be diagnosed
as factor IX or factor VIII (eight) deficiency.
Your doctor may want you to receive a hepatitis vaccination before you start using
factor IX 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. Always check the strength of the medicine on the label to be sure you
are using the correct potency.
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.
Factor IX 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 avoid while taking factor IX complex?
Follow your doctor's instructions about any restrictions on food, beverages, or activity
while you are using factor IX complex.
What other drugs will affect factor IX complex?
There may be other drugs that can affect factor IX 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.
What happens if I have an overdose of factor IX complex?
