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Brand Names: Angiomax

Generic Name: bivalirudin (Pronunciation: bye VAL i roo din)

• What is bivalirudin (Angiomax)?
• What are the possible side effects of bivalirudin (Angiomax)?
• What is the most important information I should know about bivalirudin (Angiomax)?
• What should I discuss with my health care provider before taking bivalirudin (Angiomax)?
• How should I take bivalirudin (Angiomax)?
• What happens if I miss a dose (Angiomax)?
• What happens if I overdose (Angiomax)?
• What should I avoid while taking bivalirudin (Angiomax)?
• What other drugs will affect bivalirudin (Angiomax)?
• Where can I get more information?

What is bivalirudin (Angiomax)?

Bivalirudin keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Bivalirudin is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing a procedure called angioplasty (to open blocked arteries).

Bivalirudin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of bivalirudin (Angiomax)?

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

Call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• pain or swelling in one or both legs;
• any bleeding that will not stop;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• slow heart rate;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
• decreased blood pressure (feeling light-headed or fainting); or
• urinating less than usual or not at all.

Less serious side effects are more likely to occur, such as:

• pain in your back or pelvis;
• nausea, vomiting, stomach pain or upset;
• feeling restless or nervous;
• headache;
• fever;
• sleep problems (insomnia);
• pain, bleeding, or irritation where the injection was given.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about bivalirudin (Angiomax)?

Do not use this medication if you are allergic to bivalirudin, or if you have any major bleeding from a surgery, injury, or other medical trauma.

Bivalirudin is not expected to be harmful to an unborn baby. However, aspirin is usually given with bivalirudin, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment with bivalirudin and aspirin.

Before using bivalirudin, tell your doctor if you are allergic to any drugs, or if you have heart disease, kidney disease, or a bleeding or blood clotting disorder such as hemophilia.

Tell your doctor if you are using or receiving blood thinners or any other medications used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase).

Because bivalirudin keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.