What is coagulation factor IX?
Coagulation factor IX is a man-made protein that is similar to a natural protein in the
body that helps the blood to clot.
Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B.
This medication is not for treating people with hemophilia A factor VII deficiency.
Coagulation factor IX may also be used for purposes other than those listed here.
What should I discuss with my healthcare provider before taking coagulation factor IX?
Do not use this medication if you have ever had an allergic reaction to a clotting
factor medication, or if you are allergic to hamster proteins.
Before using this medication, tell your doctor if you are allergic to latex rubber, or if you
have:
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 coagulation factor IX 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.
How should I take coagulation factor IX?
Coagulation factor IX 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 given
instructions on how to use your injections at home.
Do not use this medicine at home if you do not fully understand how to give the
injection and properly dispose of needles and other items used in giving the medicine.
Use each disposable needle only one time. Throw away used needles and syringes 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.
Coagulation factor IX is a powder medication that must be mixed with a liquid (diluent)
before injecting it. Use the injection within 3 hours after mixing your dose.
To be sure this medication is helping your condition, your blood will 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 a bleeding
disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who
treats you should know about your condition.
If you store this medication at home, keep the powder medicine in the refrigerator.
Do not freeze. Avoid exposing the medication to sunlight.
The diluent can be stored at room temperature. You may also coagulation factor IX
powder at cool room temperature for up to 6 months.
What happens if I miss a dose of coagulation factor IX?
Contact your doctor if you miss a dose of this medication.
Where can I get more information about coagulation factor IX?
Your pharmacist has information about coagulation factor IX written for health professionals that you may read.
What are the possible side effects of coagulation factor IX?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
-
fever or chills;
-
continued bleeding after treatment;
-
feeling like you might pass out;
-
sudden numbness or weakness, especially on one side of the
body;
-
sudden headache, confusion, problems with vision, speech,
or balance; or
-
swelling in your feet or ankles, weight gain, loss of appetite.
Less serious side effects may be more likely to occur, such as:
-
headache;
-
warmth, redness, or tingly feeling under your skin;
-
nausea, vomiting;
-
dizziness; or
-
pain, redness, or swelling where the medicine was injected.
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 coagulation factor IX?
Do not use this medication if you have ever had an allergic reaction to a clotting
factor medication, or if you are allergic to hamster proteins.
Before using this medication, tell your doctor if you are allergic to latex rubber, or if you
have liver disease, coronary artery disease (hardening of the arteries), or a history of stroke or
heart attack.
To be sure this medication is helping your condition, your blood will 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 a bleeding
disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who
treats you should know about your condition.
What should I avoid while taking coagulation factor IX?
Follow your doctor's instructions about any restrictions on food, beverages, or activity
while you are using coagulation factor IX.
What other drugs will affect coagulation factor IX?
There may be other drugs that can interact with coagulation factor IX. 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 coagulation factor IX?
