Coagulation factor VIIa is a man-made protein 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 purposes not listed in this medication guide.

You should not receive coagulation factor VIIa if you are allergic to it.

If possible before you receive coagulation factor VIIa, tell your doctor if you have:

• coronary artery disease (hardening of the arteries);
• a history of stroke or heart attack;
• a severe injury or infection;
• liver disease; or
• if you are allergic to mouse, hamster, or cow proteins.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether coagulation factor VIIa passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving this medicine.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Use Novoseven RT (Coagulation Factor Viia (Injection)) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden numbness or weakness, especially on one side of the body;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• fever;
• little or no urinating;
• a feeling that you might pass out; or
• any bleeding that will not stop.

Common side effects may include:

• mild headache;
• joint pain;
• nausea, vomiting;
• swelling;
• mild itching or rash; or
• pain, redness, swelling, or irritation where the medicine was injected.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.