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Coagulation Factor VIIa (Recombinant)

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

Coagulation Factor VIIa (Recombinant) 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.

Coagulation Factor VIIa (Recombinant) is a clotting factor. It works by activating the body's clotting system.

Do NOT use Coagulation Factor VIIa (Recombinant) if:

  • you are allergic to any ingredient in Coagulation Factor VIIa (Recombinant)
  • 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 Coagulation Factor VIIa (Recombinant) :

Some medical conditions may interact with Coagulation Factor VIIa (Recombinant) . 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 kidney problems, 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
  • if you are also using another type of coagulation factor VIIa

Some MEDICINES MAY INTERACT with Coagulation Factor VIIa (Recombinant) . 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 Coagulation Factor VIIa (Recombinant) 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 Coagulation Factor VIIa (Recombinant) :

Use Coagulation Factor VIIa (Recombinant) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Coagulation Factor VIIa (Recombinant) is usually given as an injection at your doctor's office, hospital, or clinic.
  • If you miss a dose of Coagulation Factor VIIa (Recombinant) , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Coagulation Factor VIIa (Recombinant) .

Important safety information:

  • Lab tests, including bleeding time, may be performed while you use Coagulation Factor VIIa (Recombinant) . 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 Coagulation Factor VIIa (Recombinant) while you are pregnant. It is not known if Coagulation Factor VIIa (Recombinant) is found in breast milk. Do not breast-feed while taking Coagulation Factor VIIa (Recombinant) .

Possible side effects of Coagulation Factor VIIa (Recombinant) :

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:

Headache; joint aches; mild fever; mild pain, swelling, or redness at the injection site; nausea; vomiting.

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); bleeding at the injection site; bloody stools; calf or stomach pain, tenderness, or swelling; chest pain; confusion; dizziness; fainting; numbness of an arm or leg; one-sided weakness; shortness of breath; sudden severe headache or vomiting; swelling; uncontrolled bleeding; vision or speech changes; vomiting blood or material that looks like coffee grounds; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Proper storage of Coagulation Factor VIIa (Recombinant) :

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

General information:

  • If you have any questions about Coagulation Factor VIIa (Recombinant) , please talk with your doctor, pharmacist, or other health care provider.
  • Coagulation Factor VIIa (Recombinant) 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 Coagulation Factor VIIa (Recombinant) . 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.