Feiba

Feiba is used by people with hemophilia who have developed antibodies to clotting factor medicines.

Hemophilia is a genetic disorder that affects blood clotting and is usually treated with medicines that contain clotting factors to help stop bleeding. When the body makes antibodies or "inhibitors" against these clotting factors, the treatment becomes less effective at preventing bleeding episodes. Feiba helps improve blood clotting and reduce the risk of bleeding by working around the effects of these inhibitors.

Feiba is used to treat or prevent bleeding episodes in people with hemophilia A or B who have developed inhibitors. Feiba is also used to control bleeding during surgery in people with hemophilia and inhibitors. This medicine is not for treating bleeding episodes in individuals who do not have inhibitors.

Feiba may also be used for other reasons not mentioned in this medication guide.

Feiba may raise your chances of experiencing a stroke or heart attack.

Contact your doctor or get emergency medical help immediately if you have--sudden numbness or weakness, sudden headache, slurred speech, chest pain, trouble breathing, sudden cough with blood, warmth or swelling in your leg.

You should not use Feiba if:

• you have had a severe allergic reaction to Feiba 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 Feiba 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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether anti-inhibitor coagulant complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Feiba 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.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor or seek emergency medical help right away if you have:

• 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;
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects of Feiba 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.

Feiba 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, Feiba 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. Feiba doses are based on weight in children, and any changes may affect your child's dose.

Feiba 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.

Keep the medicine and diluent in their original container and store at room temperature, away from moisture, heat, and light. Do not allow the medicine to freeze.

After mixing Feiba with the diluent, store the mixture at room temperature and use it within 3 hours. Do not refrigerate mixed medicine.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Call your doctor for guidance if you miss a dose of Feiba.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Tell your doctor about all the medicines you are currently taking and any that you start or stop, 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.