When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not receive it if you had an allergic reaction to bivalirudin, or if you have any active bleeding.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how bivalirudin works. Tell your doctor if you are taking any of the following:
  
  • A blood thinner, such as heparin or warfarin
  • Medicine to dissolve blood clots, such as streptokinase, urokinase, alteplase, or reteplase

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, you have a kidney problem, a bleeding disorder such as hemophilia, or you bruise easily. Tell your doctor if you are receiving brachytherapy.
• This medicine may make you bleed and bruise more easily. Be extra careful to prevent injuries, bruises, and cuts until the effects of the medicine have worn off.
• Check for any bleeding from open areas, such as around the injection site. Also check for blood in your urine or stool. Tell your doctor right away if you have any bleeding or injuries.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools
• Chest pain
• Decrease in how much or how often you urinate
• Lightheadedness or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed
• Red or dark brown urine
• Slow heartbeat
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Back or hip pain
• Fever
• Mild headache
• Nausea, vomiting, stomach pain, or upset stomach
• Trouble sleeping, anxiety, or nervousness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088