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ARIXTRA (fondaparinux sodium) ®
(Ah-RIX-trah)
(fondaparinux) Sodium Injection

Read the Patient Information that comes with ARIXTRA (fondaparinux sodium) before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about ARIXTRA (fondaparinux sodium) , ask your doctor or pharmacist.

What is the most important information I should know about ARIXTRA (fondaparinux sodium) ?

Certain medical procedures involving the spine, such as an epidural (pain medication given through the spine), spinal anesthesia, or spinal puncture, may be used during your hospital stay. If you need any of these procedures while receiving ARIXTRA (fondaparinux sodium) , heparins, heparinoids, or low-molecular weight heparins (anticoagulants), you may be at risk for having a blood clot (hematoma) in or around your spine. This type of clot is very serious, as it can cause long-term and possibly permanent paralysis (loss of the ability to move).

If you receive ARIXTRA (fondaparinux sodium) after an epidural or spinal anesthetic is used, as the anesthesia for your surgery, your doctor will watch you closely for problems with feeling (sensation) and being able to move. Tell your doctor right away if you have any of these signs and symptoms, especially in your legs and feet:

• tingling
• numbness
• muscle weakness

Because the risk of bleeding may be higher, tell your doctor before taking ARIXTRA (fondaparinux sodium) if you:

• are also taking certain other medicines that affect blood clotting such as aspirin, an NSAID (for example, ibuprofen or naproxen), clopidogrel, or warfarin sodium.
• have bleeding problems.
• had problems in the past with pain medication given through the spine.
• have had surgery to your spine.
• have a spinal deformity.

What is ARIXTRA (fondaparinux sodium) ?

ARIXTRA (fondaparinux sodium) is a prescription medicine that “thins your blood” (also known as an anticoagulant). ARIXTRA (fondaparinux sodium) is used to:

• help prevent blood clots from forming in patients who have had certain surgeries of the hip, knee, or the stomach area (abdominal surgery)
• treat people who have blood clots in their legs or blood clots that travel to their lungs

It is not known if ARIXTRA (fondaparinux sodium) is safe and effective for use in children younger than 18 years of age.

Who should not take ARIXTRA (fondaparinux sodium) ?

Do not take ARIXTRA (fondaparinux sodium) if you have:

• certain kidney problems
• active bleeding problems
• an infection in your heart
• low platelet counts and if you test positive for a certain antibody while you are taking ARIXTRA (fondaparinux sodium) .

People who weigh less than 110 pounds (50 kg) should not use ARIXTRA (fondaparinux sodium) to prevent blood clots from forming after surgery.

What should I tell my doctor before taking ARIXTRA (fondaparinux sodium) ?

Tell your doctor about all of your medical conditions, including if you:

• have had any bleeding problems (such as stomach ulcers)
• have had a stroke
• have had recent surgeries, including eye surgery
• have diabetic eye disease
• have kidney problems
• have uncontrolled high blood pressure
• have a latex allergy. The packaging (needle guard) for ARIXTRA (fondaparinux sodium) contains dry natural rubber.
• are pregnant. It is not known if ARIXTRA (fondaparinux sodium) will harm your unborn baby. If you are pregnant, talk to your doctor about the best way for you to prevent or treat blood clots.
• are breast-feeding. It is not known if ARIXTRA (fondaparinux sodium) passes into breast milk.

Tell your doctor about all the medicines you take including prescriptions and non-prescription medicines, vitamins, and herbal supplements. Some medicines can increase your risk of bleeding. Especially tell your doctor if you take:

• aspirin
• NSAIDS (such as ibuprofen or naproxen)
• other blood thinner medicines, such as clopidogrel or warfarin

See “What is the most important information I should know about ARIXTRA (fondaparinux sodium) ?” Do not start taking any new medicines without first talking to your doctor.

Know the medicines you take. Tell all your doctors and dentist that you take ARIXTRA (fondaparinux sodium) , especially if you need to have any kind of surgery or a dental procedure. Keep a list of your medicines and show it to all your doctors and pharmacist before you start a new medicine.

How should I take ARIXTRA (fondaparinux sodium) ?

• Take ARIXTRA (fondaparinux sodium) exactly as prescribed by your doctor.
• ARIXTRA (fondaparinux sodium) is given by injection under the skin (subcutaneous injection). See “How should I give an injection of ARIXTRA (fondaparinux sodium) ?”
• If your doctor tells you that you may give yourself injections of ARIXTRA (fondaparinux sodium) at home, you will be shown how to give the injections first before you do them on your own.
• Tell your doctor if you have any bleeding or bruising while taking ARIXTRA (fondaparinux sodium) .
• If you miss a dose of ARIXTRA (fondaparinux sodium) , take your dose as soon as you remember. Do not take 2 doses at the same time.
• If you take too much ARIXTRA (fondaparinux sodium) , call your doctor right away.
• Do not use ARIXTRA (fondaparinux sodium) if:
  • the solution appears discolored (the solution should normally appear clear),
  • you see any particles in the solution, or
  • the syringe is damaged.

What are possible side effects of ARIXTRA (fondaparinux sodium) ?

ARIXTRA (fondaparinux sodium) can cause serious side effects. See “What is the most important information I should know about ARIXTRA (fondaparinux sodium) ?”

• Severe bleeding
  Certain conditions can increase your risk for severe bleeding, including:
  • some bleeding problems
  • some gastrointestinal problems including ulcers
  • some types of strokes
  • uncontrolled high blood pressure
  • diabetic eye disease
  • soon after brain, spine, or eye surgery
  • Certain kidney problems can also increase your risk of bleeding with ARIXTRA (fondaparinux sodium) . Your doctor may check your kidney function while you are taking ARIXTRA (fondaparinux sodium) .
  • People undergoing surgery who weigh less than 110 pounds. See “Who should not take ARIXTRA (fondaparinux sodium) ?”
  • Low blood platelets. Low blood platelets can happen when you take ARIXTRA (fondaparinux sodium) . Platelets are blood cells that help your blood to clot normally. Your doctor may check
    your platelet counts while you take ARIXTRA (fondaparinux sodium) .
    You may bruise or bleed more easily while taking ARIXTRA (fondaparinux sodium) , and it may take longer than usual for bleeding to stop.
    Tell your doctor if you have any of these signs or symptoms of bleeding while taking ARIXTRA (fondaparinux sodium) .
    • any bleeding
    • bruising
    • rash of dark red spots under the skin
• Allergic reactions. See “What should I tell my doctor before taking ARIXTRA (fondaparinux sodium) ?”

Other side effects include:

• Injection site reactions. Bleeding, rash, and itching can happen at the place where you inject ARIXTRA (fondaparinux sodium) .
• Low red blood cell counts (anemia). Your doctor may check your red blood cell counts while you are taking ARIXTRA (fondaparinux sodium) .
• Increased liver enzyme test results. Your doctor may check your liver function while you are taking ARIXTRA (fondaparinux sodium) .
• Sleep problems (insomnia).

These are not all the possible side effects of ARIXTRA (fondaparinux sodium) . Call your doctor if you have any side effects that bother you or don't go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ARIXTRA (fondaparinux sodium) ?

Store ARIXTRA (fondaparinux sodium) at room temperature 59°F to 86°F (15°C to 30°C). Do not freeze.

Safely, throw away ARIXTRA (fondaparinux sodium) that is out of date or no longer needed.

Keep ARIXTRA (fondaparinux sodium) and all medicines out of the reach of children.

General information about ARIXTRA (fondaparinux sodium)

Medicines are sometimes prescribed for purposes other than those described in patient information leaflets. Do not use ARIXTRA (fondaparinux sodium) for a condition for which it was not prescribed. Do not give ARIXTRA (fondaparinux sodium) to other people. It may harm them.

This leaflet summarizes the most important information about ARIXTRA (fondaparinux sodium) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ARIXTRA (fondaparinux sodium) that is written for healthcare professionals. For more information about ARIXTRA (fondaparinux sodium) , go to www.ARIXTRA (fondaparinux sodium) .com or call 1-888-825-5249.

What are the ingredients in ARIXTRA?

Active Ingredient: fondaparinux sodium

Inactive Ingredients: sodium chloride and water for injection

How should I give an injection of ARIXTRA (fondaparinux sodium) ?

ARIXTRA (fondaparinux sodium) is injected into a skin fold of the lower stomach area (abdomen). Do not inject

ARIXTRA (fondaparinux sodium) into muscle. Usually a doctor or nurse will give this injection to you. In some cases you may be taught how to do this yourself. Be sure that you read, understand, and follow the step-by-step instructions in this leaflet, on how to give yourself an injection of ARIXTRA (fondaparinux sodium) .

Instructions for self-administration

The different parts of ARIXTRA safety syringe are:
Rigid needle guard Cap Plunger Finger-grip Security sleeve
Syringe BEFORE USE	Syringe AFTER USE
1. Wash your hands thoroughly with soap and water. Towel dry.
2. Sit or lie down in a comfortable position. Choose a spot on the lower stomach area (abdomen), at least 2 inches below your belly button (Figure A). Change (alternate) between using the left and right side of the lower abdomen for each injection. If you have any questions talk to your nurse or doctor.	Figure A
3. Clean the injection area with an alcohol swab.
4. Hold the security sleeve firmly in one hand. Pull off the cap that protects the plunger (Figure B). Discard the plunger cap.	Figure B
5. Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (Figure C). Discard the needle guard. To prevent infection, do not touch the needle or let it come in contact with any surface before the injection. A small air bubble in the syringe is normal. To be sure that you do not lose any medicine from the syringe, do not try to remove air bubbles from the syringe before giving the injection.	Figure C
6. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger of one hand during the entire injection (Figure D).	Figure D
7. Hold the syringe firmly in your other hand using the finger grip. Insert the full length of the needle directly up and down (at an angle of 90°) into the skin fold (Figure E).	Figure E
8. Inject all of the medicine in the syringe by pressing down on the plunger as far as it goes. This will activate the automatic needle protection system (Figure F).	Figure F
9. Release the plunger. The needle will withdraw automatically from the skin, and pull back (retract) into the security sleeve where it will be locked (Figure G).	Figure G
Follow the instructions given to you by your nurse or doctor about the right way to throw away used syringes and needles. There may be state laws about the right way to dispose of used syringes, needles, and disposal containers.

Last reviewed on RxList: 4/15/2010
This monograph has been modified to include the generic and brand name in many instances.