DrugindexOnline^{2nd edition}

Generic Name: Coagulation Factor VIIa (Recombinant) (koe-AG-yoo-lay-shun FAK-tor)
Brand Name: Novoseven

Novoseven is used for:

Treating or preventing bleeding episodes in certain patients with bleeding problems such as hemophilia A or B, acquired hemophilia, or congenital FVII deficiency.

Novoseven is a clotting factor. It works by activating the body's clotting system.

Do NOT use Novoseven if:

• you are allergic to any ingredient in Novoseven
• you are allergic to mouse, hamster, or cow proteins

Contact your doctor or health care provider right away if any of these apply to you.

Before using Novoseven :

Some medical conditions may interact with Novoseven . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have hardening of the arteries, disseminated intravascular coagulation (DIC), an infection of the blood or tissues, or blood conditions other than hemophilia
• if you have a blood clot or history of blood clots
• if you have a crush injury

Some MEDICINES MAY INTERACT with Novoseven . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Activated or nonactivated prothrombin complex concentrates because the risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Novoseven :

Use Novoseven as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Novoseven is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Novoseven at home, a health care provider will teach you how to use it. Be sure you understand how to use Novoseven . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Novoseven if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Any leftover medicine or supplies used with Novoseven should be placed in a plastic bag and disposed of as instructed by your doctor or pharmacist.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials.
• If you miss a dose of Novoseven , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Novoseven .

Important safety information:

• Lab tests, including bleeding time, may be performed while you use Novoseven . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Novoseven while you are pregnant. It is not known if Novoseven is found in breast milk. Do not breast-feed while taking Novoseven .

Possible side effects of Novoseven :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fever.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain or tenderness; chest pain; confusion; dizziness; fainting; infection (chills and fever); lightheadedness; numbness of an arm or leg; one-sided weakness; pain, redness, or swelling at the injection site; severe stomach pain; shortness of breath; stomach bleeding; sudden severe headache, dizziness, vomiting, or fainting; uncontrolled bleeding; vision or speech changes; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Novoseven :

Novoseven is usually handled and stored by a health care provider. If you are using Novoseven at home, store Novoseven as directed by your pharmacist or health care provider. Keep Novoseven out of the reach of children and away from pets.

General information:

• If you have any questions about Novoseven , please talk with your doctor, pharmacist, or other health care provider.
• Novoseven is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Novoseven . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.