Arixtra is a brand name for fondaparinux sodium injection, a synthetic inhibitor of activated Factor X (Xa). It is available as a prefilled syringe for subcutaneous injection with dosages of 2.5 mg, 5 mg, 7.5 mg, or 10 mg. The solution is isotonic and contains sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH.

How should I use this medication?

This medication is injected under the skin. This medication is injected under the skin. It can be given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses or stopping this medication can increase your risk of a blood clot. Keep taking this medication unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

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 care team to get one.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

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.

Where should I keep my medication?

Keep out of the reach of children and pets.

See product label for storage information. Each product may have different instructions. Get rid of any unused medication as instructed or after the expiration date, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting

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

• Confusion
• Dizziness
• Pain, redness, or irritation at injection site
• Trouble sleeping

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.

What should I tell my care team before I take this medication?

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

• Bleeding problems
• Eye disease caused by diabetes
• Have had a stroke
• High blood pressure
• Infection in your heart
• Kidney disease
• Liver disease
• Low platelet levels
• Recent pregnancy
• Recent surgery, including eye surgery
• An unusual or allergic reaction to fondaparinux, latex, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Defibrotide
• Mifepristone

This medication may also interact with the following:

• Aspirin and aspirin-like medications
• Antiplatelet medications, such as cilostazol, clopidogrel, dipyridamole, ticlopidine
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Other blood thinners, such as heparin or warfarin

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 medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Avoid sports and activities that may cause injury while you are taking this medication. 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 care team.

If you are going to need surgery or a procedure, tell your care team that you are taking this medication.

People who take this medication and have a spinal procedure are at risk of forming a blood clot in the space around the brain or spinal cord. This could cause paralysis (not being able to move). The risk is higher in people who have spinal problems or injuries, have had spinal surgery in the past, and for those with a tube (catheter) in their back. Taking other medications that also affect bleeding, such as NSAIDs or other blood thinners, can also increase the risk. Your care team will watch you closely. Let them know right away if you feel pain, tingling, or numbness in your legs or feet.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What are the most serious risks of this medication?

People who take this medication and have a spinal procedure are at risk of forming a blood clot in the space around the brain or spinal cord. This could cause paralysis (not being able to move). The risk is higher in people who have spinal problems or injuries, have had spinal surgery in the past, and for those with a tube (catheter) in their back. Taking other medications that also affect bleeding, such as NSAIDs or other blood thinners, can also increase the risk. Your care team will watch you closely. Let them know right away if you feel pain, tingling, or numbness in your legs or feet.