Coagulation Factor VIIa (Recombinant), Injection

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KEY POINTS

• This medicine is given by IV injection to prevent or stop bleeding in people who have certain types of hemophilia.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe or life-threatening blood clots or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihemophilic; coagulation factor

Generic and brand names: coagulation factor VIIa, recombinant, injection; NovoSeven RT

What is this medicine used for?

This medicine is given by IV injection to prevent or stop bleeding in people who have:

• Hemophilia A or B and who have inhibitors to Factor VIII or Factor IX
• Factor VII deficiency or acquired hemophilia
• Glanzmann’s thrombasthenia when platelet transfusions do not work

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or if you are allergic to beef, mice, or hamsters.
• A stroke or transient ischemic attack (TIA)
• Blood clots
• Heart disease or a heart attack
• Liver disease

Also tell your healthcare provider if you have recently had a long period of bedrest after major surgery or wearing a cast.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is given by IV injection (shots into a large vein). These shots are usually given over 2 to 5 minutes while you are in the hospital. Usually you will have a shot every 2 hours until the bleeding is stopped or until your healthcare provider decides to stop the treatment. Your healthcare provider will decide your exact dose and how often you should receive it. The number of shots you need depends on where you are bleeding, how severe your bleeding is, and how quickly it stops. You may need several doses.

What should I watch out for?

This medicine may cause severe or life-threatening blood clots. Tell your healthcare provider right away if you have any signs of blood clots, including new swelling or pain in your legs or abdomen, chest pain, shortness of breath, sudden headache or cough, numbness or weakness (especially on one side of your body), or problems with vision, speech, or balance.

You will have several blood tests to determine your blood clotting time.

Your body may make antibodies that prevent this medicine from working. Tell your healthcare provider if this medicine does not seem to be working as well as usual. If your bleeding is not controlled after you receive this medicine, contact your healthcare provider right away.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Signs of too much blood clotting (shortness of breath; sudden cough; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; sharp pain in the chest, upper arm, or legs; swelling, pain, or redness in lower legs). Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; unusual bruising or bleeding; blood in the urine or bowel movement; fever; decreased urination; slow, fast, or irregular heartbeat; severe dizziness or fainting.

Other: Mild headache, vomiting, nausea, irritation at spot where the shot was given, mild dizziness, joint pain, mild itching or rash.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Coagulation factor XIII (Corifact, Tretten)
• Prothrombin complex concentrate (Kcentra)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.