NovoSeven RT

Generic Name: coagulation factor VIIa (injection) (koe AG yoo LAY shun FAK tor )Brand Names: NovoSeven, NovoSeven RT

What is coagulation factor VIIa?

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

What is the most important information I should know about coagulation factor VIIa?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have coronary artery disease (hardening of the arteries), a history of stroke or heart attack, a severe injury or infection, or if you are allergic to mouse, hamster, or pork proteins.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.What should I discuss with my healthcare provider before using coagulation factor VIIa?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using 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; or

• if you are allergic to mouse, hamster, or pork proteins.

FDA pregnancy category C. Coagulation factor VIIa may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coagulation factor VIIa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use coagulation factor VIIa?

Coagulation factor VIIa is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You may need to mix coagulation factor VIIa with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition. NovoSeven should be stored in the refrigerator. Do not freeze. Avoid exposing the medication to sunlight. NovoSeven RT may be stored at cool room temperature away from moisture, heat, and light.

After mixing NovoSeven RT with a diluent, you may keep it at room temperature or in the refrigerator and use it within 3 hours. Do not freeze or store the mixture in a syringe.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of coagulation factor VIIa is not expected to produce life-threatening symptoms.

What should I avoid while using coagulation factor VIIa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

Coagulation factor VIIa side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fever;

• any bleeding that will not stop;

• feeling like you might pass out;

• urinating less than usual or not at all;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance; or

• pain or swelling in one or both legs.

Less serious side effects may include:

• 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect coagulation factor VIIa?

Tell your doctor about all other medications you use, especially medications used to treat severe bleeding episodes, such as:

• aminocaproic acid (Amicar); or

• tranexamic acid (Cyklokapron).

This list is not complete and there may be other drugs that can interact with coagulation factor VIIa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about coagulation factor VIIa.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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