Fondaparinux Sodium Solution for injection

What is this medicine?

FONDAPARINUX is used after knee, hip, or abdominal surgeries to prevent blood clotting. It is also used to treat existing blood clots in the lungs or in the veins.

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, hemorrhage, or hemophilia
• infection of the heart or heart valves
• kidney or liver disease
• previous stroke
• recent surgery or child birth
• ulcer in the stomach or intestine, diverticulitis, or other bowel disease
• an unusual or allergic reaction to fondaparinux, heparin, low molecular weight heparins, 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. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

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

• aspirin and aspirin-like medicines
• heparin
• mifepristone
• warfarin

This medicine may also interact with the following medications:

• antiinflammatory drugs like ibuprofen
• cilostazol
• clopidogrel
• dipyridamole
• sulfinpyrazone
• ticlopidine

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 checks on your progress. Your condition will be monitored carefully while you are receiving this medicine. Contact your doctor or health care professional and seek emergency treatment if you develop increased difficulty in breathing, chest pain, dizziness, shortness of breath, swelling in the legs or arms, abdominal pain, decreased vision, pain when walking, or pain and warmth of the arms or legs. These can be signs that your condition has gotten worse.

Monitor your skin closely for easy bruising or red spots, which can be signs of bleeding. If you notice easy bruising or minor bleeding from the nose, gums/teeth, in your urine, or stool, contact your doctor or health care professional right away. The dose of your medicine may need to be changed.

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

Try to avoid injury while you are using this medicine. Be careful when brushing or flossing your teeth, shaving, cutting your fingernails or toenails, or when using sharp objects. Report any injuries to your doctor or health care professional.

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
• bleeding from the injection site
• difficulty breathing
• dizziness or fainting spells
• fever
• heavy menstrual bleeding
• signs and symptoms of bleeding such as back or stomach pain, black, tarry stools, blood in the urine, or coughing up blood
• unusual bruising or bleeding: bleeding gums, red spots on the skin, nosebleeds

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

• pain or 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?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.