Coagulation Factor XIII A-Subunit Solution for injection

What is this medicine?

FACTOR XIII A-SUBUNIT, RECOMBINANT is used in patients with factor XIII A-subunit deficiency to help prevent bleeding.

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:

• history of blood clots

• an unusual or allergic reaction to factor XIII A-subunit, recombinant, 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 given by a health care professional in a hospital or clinic setting.

In rare cases, you might get this medicine at home. You will be taught how to give this medicine. 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 health care provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

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?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

This medicine may interact with the following medications:

• factor VIIa, recombinant

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?

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

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:

• allergic reactions like skin rash, itching or hives, swelling of face, lips, or tongue

• pain, swelling, warmth in the leg

• shortness of breath or chest pain

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

• headache

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.

This drug is usually given in a hospital or clinic and will not be stored at home.

In rare cases, this medicine may be given at home. 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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.