Anti-Inhibitor Coagulant Complex Solution for injection

What is this medicine?

ANTI-INHIBITOR COAGULANT COMPLEX (AN tahy-in HIB i ter koh AG yuh luhnt KOM pleks) is used in patients with hemophilia to help control 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:

• low platelet levels

• other coagulation problems

• thrombosis

• an unusual or allergic reaction to human 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 are given this medicine for home use, you will be instructed in the proper injection technique. Follow the directions exactly.

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

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?

• aminocaproic acid

• tranexamic acid

You may be given one of the above drugs to take. However, you should wait at least 12 hours after receiving this medicine before taking either of the above drugs.

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?

This medicine is made from human plasma, and there is a small risk that they may contain certain types of virus or bacteria. All products are processed to kill most viruses and bacteria. If you have questions concerning the risk of infections, discuss them with your doctor or health care professional.

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:

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

• breathing problems

• chest pain or tightness

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills

• pain, redness or swelling at the injection site

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

• flushing

• 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.

Be sure to follow the directions for the specific product you take. Most products are stored in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. This medicine may be stored at room temperature between 15 and 30 degrees C (59 and 86 degrees C) for up to 6 months. If stored at room temperature, do not return the vials to the refrigerator. Throw away after expiration date or after 6 months if stored at room temperature, whichever comes first.

Once the solution has been prepared for a dose, use it within 3 hours. Throw away any unused solution.