What is the most important information I should know about anti-inhibitor coagulant complex?

What is anti-inhibitor coagulant complex?

Anti-inhibitor coagulant complex is used in people who have hemophilia and have developed antibodies to clotting factor medications.

Hemophilia, an inherited blood-clotting disorder, is often treated with medicines containing clotting factors that help control bleeding. When the body develops antibodies or "inhibitors" to the clotting factor, this treatment becomes less effective in preventing bleeding episodes. Anti-inhibitor coagulant complex works by bypassing the effects of these inhibitors to improve blood clotting and decrease the risk of bleeding.

Anti-inhibitor coagulant complex is used to treat or prevent bleeding episodes in people with hemophilia A or B who have developed inhibitors. This medicine is also used to control bleeding related to surgery in people with hemophilia and inhibitors. Anti-inhibitor coagulant complex is not for treating bleeding episodes in people who do not have inhibitors.

Anti-inhibitor coagulant complex may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using anti-inhibitor coagulant complex?

• you have had a severe allergic reaction to this medicine or other antihemophilic factors;
• you have a blood condition called disseminated intravascular coagulation;
• you have a current blood clot anywhere in your body; or
• you have recently had a stroke or heart attack.

To make sure anti-inhibitor coagulant complex is safe for you, tell your doctor if you have:

• coronary artery disease;
• a history of heart attack, stroke, or blood clot;
• a recent major injury; or
• a serious infection called sepsis.

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use anti-inhibitor coagulant complex?

Anti-inhibitor coagulant complex is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

To treat a bleeding episode, this medicine is usually given once every 6 to 12 hours until your condition improves. For routine prevention of bleeding, anti-inhibitor coagulant complex may be given every other day. Follow your doctor's dosing instructions very carefully.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Anti-inhibitor coagulant complex doses are based on weight in children, and any changes may affect your child's dose.

Anti-inhibitor coagulant complex is a powder medicine that must be mixed 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 medicine.

Do not use the medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

After mixing anti-inhibitor coagulant complex with the diluent, store the mixture at room temperature and use it within 3 hours. Do not refrigerate mixed medicine.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using anti-inhibitor coagulant complex?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of anti-inhibitor coagulant complex?

• bruising, swelling, or pain around a joint;
• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood or;
• signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• anemia;
• nausea, vomiting, diarrhea;
• bruising;
• altered sense of taste; or
• a positive hepatitis B antibody test.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect anti-inhibitor coagulant complex?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• coagulation factor VIIa;
• aminocaproic acid; or
• tranexamic acid.

This list is not complete. Other drugs may interact with anti-inhibitor coagulant complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about anti-inhibitor coagulant complex.