Coagulation factor VIIa (injection)

Coagulation factor VIIa is a synthetic protein that works like a natural protein in the body that aids in blood clotting.

Coagulation factor VIIa is used to treat or prevent bleeding in individuals with hemophilia A, hemophilia B, or factor VII deficiency.

Coagulation factor VIIa may also be used for other reasons not mentioned in this medication guide.

Coagulation factor VIIa can lead to serious or life-threatening side effects. Contact your doctor immediately if you experience chest pain, shortness of breath, dizziness, pain, swelling, or warmth in one leg, sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, or any issues with vision or balance.

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

Tell your doctor if you have or have ever had:

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

It is not known if coagulation factor VIIa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using coagulation factor VIIa.

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

Coagulation factor VIIa may cause serious side effects. Call your doctor right away if you have:

• signs of a stroke—sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung—chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body—pain, swelling, or warmth in one leg;
• fever;
• little or no urination;
• feeling like you might faint; or
• any bleeding that won’t stop.

Common side effects of coagulation factor VIIa 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.

Coagulation factor VIIa is injected into a vein by a healthcare provider.

You may need medical tests to help determine how long you should use coagulation factor VIIa.

Wear a medical alert tag or carry an ID card to let others know you have a bleeding disorder in case of emergency. Tell any doctor who treats you that you are using coagulation factor VIIa.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Tell your doctor about all the other medicines you are taking, especially medicines that treat or prevent bleeding episodes, such as:

• anti-inhibitor coagulant complex; or
• factor IX complex.

This list does not include everything. Other medicines may affect coagulation factor VIIa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.