SevenFACT (injection)

SevenFACT is a man-made protein that works like a natural protein in the body that helps blood to clot.

SevenFACT is used to treat or prevent bleeding in people with hemophilia A, hemophilia B, or factor VII deficiency.

SevenFACT may also be used for other reasons that are not mentioned in this medication guide.

SevenFACT 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 your body), severe headache, slurred speech, or issues with vision or balance.

You should not use SevenFACT 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;
• an allergy to mouse, hamster, or cow proteins; or
• liver disease.

It is not known if SevenFACT will harm an unborn baby. Inform your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using SevenFACT.

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

SevenFACT 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 that you might faint; or
• any bleeding that does not stop.

Common side effects of SevenFACT 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.

SevenFACT is injected into a vein by a healthcare provider.

You may need medical tests to help determine how long you should use SevenFACT.

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 SevenFACT.

In a medical setting, you are unlikely to miss a dose.

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

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

Tell your doctor about all your other medicines, especially those used to treat or prevent bleeding episodes, such as:

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

This list is not complete. Other drugs may affect SevenFACT, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.