Bivalirudin Solution for injection

What is this medicine?

BIVALIRUDIN is an anticoagulant. It is used in a hospital setting to help prevent blood clots.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders or hemophilia

• weak or unstable blood vessels

• an unusual or allergic reaction to bivalirudin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin or for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• agents that dissolve blood clots, like heparin

• blood thinners such as warfarin

• mifepristone

This medicine may also interact with the following medications:

• abciximab

• cilostazol

• clopidogrel

• dipyridamole

• eptifibatide

• lamifiban

• NSAIDs like ibuprofen

• ticlopidine

• tirofiban

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Your condition will be monitored carefully while you are receiving this medicine.

Notify your doctor or health care professional and seek emergency treatment if you develop breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm, or leg. These can be signs that your condition has gotten worse.

Avoid sports and activities that might cause injury while you are using this medicine. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your doctor or health care professional.

If you are going to have surgery, tell your doctor or health care professional that you have received this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dizziness

• feeling faint or lightheaded

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• irritation at the injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.