Fondaparinux Sodium, Injection

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KEY POINTS

• This medicine is given by injection to prevent or treat blood clots. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious bleeding problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anticoagulant (medicine that reduces the chance of blood clots forming)

Generic and brand names: fondaparinux sodium, injection; Arixtra

What is this medicine used for?

This medicine is given by injection (shot) to treat or prevent deep vein thrombosis (blood clots). It is also used to treat blood clots in the lungs (pulmonary embolism). This medicine may be used along with warfarin (Coumadin) to treat blood clots. You may be given this medicine if you are having surgery for:

• Certain abdominal problems
• Hip fracture
• Hip replacement
• Knee replacement

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, or to latex
• A low platelet count
• A stroke or transient ischemic attack (TIA)
• Bacterial endocarditis (heart infection)
• Bleeding problems
• Brain, spinal or eye surgery
• Eye problems due to diabetes
• Heart disease or high blood pressure
• Kidney or liver problems
• Stomach or intestinal problems such as ulcerative colitis, Crohn's disease, heartburn, ulcers, or bleeding

Tell your healthcare provider if have recently had, or will be having a spinal or epidural procedure, or if you have any kind of problems with your spine.

Be sure to tell your healthcare provider if you are taking any medicine that may increase the risk of bleeding, such as warfarin (Coumadin), aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while receiving this medicine. Do not breast-feed without your healthcare provider's approval.

How do I use it?

Your healthcare provider will give you these shots while you are in the hospital. You will receive shots subcutaneously (just under the skin). You will be closely watched to be sure that you do not bleed too much or develop any serious side effects.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help. Do not stop using this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

Try not to miss a dose. If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nosebleeds, severe bruising, black or tarry bowel movements, blood in the urine, vomiting or coughing up blood, bleeding that won’t stop.

What should I watch out for?

This medicine may increase your risk of serious bleeding problems if you have spinal anesthesia, an epidural, or a spinal tap. Rarely, this bleeding may lead to paralysis. Your risk is greater if you have problems with your spine, have an indwelling epidural catheter, or if you take other medicines that affect blood clotting. Talk with your healthcare provider about this.

Bleeding is the most common side effect. Your healthcare provider will check for bleeding. Use a soft brush to brush your teeth. Avoid injury while shaving, cutting fingernails or toenails, or when using sharp objects. If you notice any bleeding, tell your healthcare provider.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Do not drink alcohol while receiving this medicine without your healthcare provider’s approval. It may increase the risk of bleeding.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness or pain in your chest, swelling of your lips, tongue or throat, trouble breathing); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; dark red spots under your skin; severe tiredness or weakness; swelling, numbness, or tingling of hands, feet, or ankles; pain in joints or back; black or tarry bowel movements; blood in your urine; decreased urination; chest pain; shortness of breath; severe dizziness or fainting; pain, redness or swelling in your lower legs; confusion; vomiting blood or material that looks like coffee grounds; muscle weakness; loss of bladder or bowel control.

Other: Dizziness, lightheadedness, trouble sleeping, irritation at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Aspirin and other salicylates
• Cancer medicines such as dasatinib (Sprycel), ibritumomab (Zevalin), ibrutinib (Imbruvica), and tositumomab (Bexxar)
• Deferasirox (Exjade, Jadenu)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), and norethindrone (Aygestin, Micronor) (Talk to your healthcare provider if you need birth control.)
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), alteplase (Activase), anagrelide (Agrylin), apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), reteplase (Retavase), rivaroxaban (Xarelto), tenecteplase (TNKase), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as iloprost (Ventavis) and treprostinil (Remodulin, Tyvaso)
• Natural remedies such as agrimony, alfalfa, anise, arnica, bilberry, black cohosh, bladderwrack, bromelain, cat’s claw, dong quai, evening primrose oil, fenugreek, feverfew, fish oil, garlic, ginger, ginkgo biloba, ginseng, goldenseal, grape seed, green tea, horse chestnut, licorice, nettle, passion flower, pau d'arco, red clover, reishi, SAMe, St. John's wort, sweet clover, turmeric, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentoxifylline
• SSRI antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft)
• Vitamin E

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original container at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.