Factor VIIa Solution for injection

What is this medicine?

FACTOR VIIa, RECOMBINANT (fak tir VIIa, ree kom bi nant) helps to prevent or control bleeding in patients with hemophilia A or hemophilia B who have clotting factor inhibitors. This medicine may also be used to treat bleeding in patients with factor VII deficiency or in select patients who have other types of bleeding problems.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• hardening of the arteries

• other coagulation problems

• thrombosis

• an unusual or allergic reaction to human or animal (cow, hamster, or mouse) protein, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Let the powder and solution warm to room temperature before use. Follow mixing directions carefully to avoid foaming. Swirl but do not shake the solution. Throw away any unused portion. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss doses. Ask your doctor or health care professional for instructions if you miss a dose.

What may interact with this medicine?

This medicine may interact with the following medications:

• factor IX products

• prothrombin complex concentrate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If you are a hemophilia patient, carry an identification card with you at all times. The card should have your name, the name and dose of your medication(s), the name and phone number of your doctor or health care professional, and a contact person in case of emergency.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• an allergic reaction including difficulty breathing, wheezing, hives, skin rash, itching, tightness of the chest

• bruising or continued bleeding

• cough or other signs of infection

• fever or chills

• pain, redness or swelling at the injection site

• swelling of legs

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.