What is coagulation factor VIIa (injection)?
Coagulation factor VIIa is a man-made protein that is similar to a natural protein in the
body that helps the blood to clot.
Coagulation factor VIIa is used to treat or prevent bleeding in people with hemophilia A
or hemophilia B, or factor VII deficiency.
Coagulation factor VIIa may also be used for other purposes not listed in this medication
guide.
What should I discuss with my healthcare provider before taking coagulation factor VIIa (injection)?
If you have certain conditions, you may need a dose adjustment or special tests to safely
use this medication. Before using coagulation factor VIIa, tell your doctor if you have:
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coronary artery disease (hardening of the arteries);
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a history of stroke or heart attack;
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a severe injury or infection; or
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if you are allergic to mouse, hamster, or pork proteins.
FDA pregnancy category C. Coagulation factor VIIa 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 VIIa 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 VIIa (injection)?
Coagulation factor VIIa 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.
You may need to mix coagulation factor VIIa with a liquid (diluent) before using it. If
you are using the injections at home, be sure you understand how to properly mix and store the
medication. Do not use the medication if it has changed colors or has any particles in it. Call
your doctor for a new prescription.
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 visits to your doctor.
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.
NovoSeven should be stored in the refrigerator. Do not freeze. Avoid exposing the
medication to sunlight.
NovoSeven RT may be stored at cool room temperature away from moisture, heat,
and light.
After mixing NovoSeven RT with a diluent, you may keep it at room temperature or in
the refrigerator and use it within 3 hours. Do not freeze or store the mixture in a syringe.
What happens if I miss a dose of coagulation factor VIIa (injection)?
Contact your doctor if you miss a dose of this medication.
Where can I get more information about coagulation factor VIIa (injection)?
Your pharmacist has information about coagulation factor VIIa (injection) written for health professionals that you may read.
What are the possible side effects of coagulation factor VIIa (injection)?
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;
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any bleeding that will not stop;
-
feeling like you might pass out;
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urinating less than usual or not at all;
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sudden numbness or weakness, especially on one side of the
body;
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sudden headache, confusion, problems with vision, speech,
or balance; or
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pain or swelling in one or both legs.
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 coagulation factor VIIa (injection)?
Before using this medication, tell your doctor if you are allergic to any drugs, or if you
have coronary artery disease (hardening of the arteries), a history of stroke or heart attack, a
severe injury or infection, or if you are allergic to mouse, hamster, or pork proteins.
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 visits to your doctor.
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 VIIa (injection)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity
while you are using this medication.
What other drugs will affect coagulation factor VIIa (injection)?
Tell your doctor about all other medications you use, especially medications used to treat
severe bleeding episodes, such as:
This list is not complete and there may be other drugs that can interact
with coagulation factor VIIa. 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 VIIa (injection)?