Bivalirudin

Bivalirudin is used for:

Thinning the blood in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty (PTCA) and in patients undergoing percutaneous coronary intervention (PCI). Bivalirudin is used in conjunction with other medicines. It may also be used for other conditions as determined by your doctor.

Bivalirudin is a thrombin inhibitor. It works by blocking the formation of blood clots.

Do NOT use Bivalirudin if:

• you are allergic to any ingredient in Bivalirudin
• you have active major bleeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bivalirudin :

Some medical conditions may interact with Bivalirudin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of blood clots or bleeding problems (eg, hemophilia)

Some MEDICINES MAY INTERACT with Bivalirudin . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin, heparin), glycoprotein IIb/IIIa inhibitors (eg, abciximab), platelet inhibitors (eg, cilostazol), or thrombolytics (eg, alteplase) because the risk of serious side effects, such as bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bivalirudin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bivalirudin :

Use Bivalirudin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Bivalirudin is administered as an injection at your doctor's office, hospital, or clinic.
• If you miss a dose of Bivalirudin , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Bivalirudin .

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Bivalirudin . Using Bivalirudin alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Bivalirudin reduces the ability of the blood to clot. To prevent bleeding, avoid situations in which bruising or injury may occur.
• LAB TESTS, including blood clotting tests and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Bivalirudin with caution in the ELDERLY because they may be more sensitive to its effects, such as bleeding.
• Use Bivalirudin with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• If you become pregnant, discuss with your doctor the benefits and risks of using Bivalirudin during pregnancy. It is unknown if Bivalirudin is excreted in breast milk. If you are or will be breast-feeding, discuss with your doctor the risks to your baby.

Possible side effects of Bivalirudin :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bleeding.

Bivalirudin is usually handled and stored by a health care provider. If you are using Bivalirudin at home, store Bivalirudin as directed by your pharmacist or health care provider. Keep Bivalirudin out of the reach of children and away from pets.

General information:

• If you have any questions about Bivalirudin , please talk with your doctor, pharmacist, or other health care provider.
• Bivalirudin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Bivalirudin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.