fondaparinux

Pronunciation

Generic Name: fondaparinux (fon DAP a rin ux)
Brand Name: Arixtra, Arixtra 5 mg/dose, Arixtra 7.5 mg/dose, Arixtra 10 mg/dose

What is fondaparinux?

Fondaparinux is an anticoagulant that helps prevent the formation of blood clots.

Fondaparinux is used to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery.

Fondaparinux is also used together with warfarin (Coumadin) to treat DVT, including pulmonary embolism.

Fondaparinux may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fondaparinux?

You should not use this medicine if you have active or uncontrolled bleeding, severe kidney disease, an infection in the lining of your heart, or a low level of platelets in your blood after testing positive for a certain antibody.

Fondaparinux can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, a history of spinal surgery or repeated spinal taps, if you have a spinal catheter in place (or it has been recently removed), or if you are also using other drugs that can affect blood clotting, including blood thinners or NSAIDs (ibuprofen, Advil, Aleve, and others). This type of blood clot can lead to long-term or permanent paralysis.

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Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

What should I discuss with my healthcare provider before using fondaparinux?

You should not use this medicine if you have ever had a severe allergic reaction to fondaparinux, or if you have:

  • active or uncontrolled bleeding;

  • severe kidney disease;

  • an allergy to heparin, or pork products;

  • an infection in the lining of your heart (also called bacterial endocarditis); or

  • a low level of platelets in your blood after testing positive for a certain antibody while using fondaparinux.

You should not use fondaparinux to prevent blood clots after surgery if you weigh less than 110 pounds (50 kilograms).

Fondaparinux may cause you to bleed more easily, especially if you have:

  • a bleeding disorder that is inherited or caused by disease;

  • hemorrhagic stroke;

  • eye problems caused by diabetes;

  • uncontrolled high blood pressure;

  • stomach or intestinal bleeding or ulcer;

  • recent brain, spine, or eye surgery;

  • kidney disease (especially if you are an older adult); or

  • if you take a salicylate (aspirin, choline salicylate, diflunisal, magnesium salicylate, salsalate, and others).

Fondaparinux can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

  • you have a genetic spinal defect;

  • you have a spinal catheter in place or if a catheter has been recently removed;

  • you have a history of spinal surgery or repeated spinal taps;

  • you have recently had a spinal tap or epidural anesthesia;

  • you are taking an NSAID (nonsteroidal anti-inflammatory drug)--ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or

  • you are using other medicines to treat or prevent blood clots.

FDA pregnancy category B. Fondaparinux is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether fondaparinux passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use fondaparinux?

Fondaparinux is usually given every day until your bleeding condition improves. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Fondaparinux is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

You should be sitting or lying down during the injection. Do not inject fondaparinux into a muscle or a vein.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use fondaparinux if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Tell any doctor who treats you that you are using fondaparinux. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication.

While using fondaparinux, your blood and your stool (bowel movement) may need to be tested often. Your nerve and muscle function may also need to be tested.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause excessive bleeding.

What should I avoid while using fondaparinux?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Fondaparinux side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;

  • easy bruising, purple or red pinpoint spots under your skin;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;

  • sudden weakness, severe headache, confusion, or problems with speech, vision, or balance; or

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, limp feeling).

Common side effects may include:

  • sleep problems (insomnia);

  • mild skin rash;

  • dizziness; or

  • minor bleeding, rash, or itching where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Fondaparinux dosing information

Usual Adult Dose for Deep Vein Thrombosis:

Dosage is based on patient's weight:
-Under 50 kg: 5 mg subcutaneously once a day
-50 to 100 kg: 7.5 mg subcutaneously once a day
-Over 100 kg: 10 mg subcutaneously once a day
Duration of therapy: At least 5 days, until INR of 2 to 3 achieved with warfarin

Comments:
-Initiate concomitant warfarin as soon as possible, usually within 72 hours.
-Usual duration 5 to 9 days; up to 26 days was administered in trials.

Uses:
-Treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
-Treatment of acute pulmonary embolism (PE) when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

Usual Adult Dose for Pulmonary Embolism:

Dosage is based on patient's weight:
-Under 50 kg: 5 mg subcutaneously once a day
-50 to 100 kg: 7.5 mg subcutaneously once a day
-Over 100 kg: 10 mg subcutaneously once a day
Duration of therapy: At least 5 days, until INR of 2 to 3 achieved with warfarin

Comments:
-Initiate concomitant warfarin as soon as possible, usually within 72 hours.
-Usual duration 5 to 9 days; up to 26 days was administered in trials.

Uses:
-Treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
-Treatment of acute pulmonary embolism (PE) when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Abdominal Surgery:

2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days

Comments:
-Administration earlier than 6 hours after surgery increases risk of major bleeding.
-The usual duration is 5 to 9 days; up to 10 days was administered in trials.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing abdominal surgery who are at risk for thromboembolic complications.

Usual Adult Dose for Deep Vein Thrombosis -- Prophylaxis:

2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days

Comments:
-Administration earlier than 6 hours after surgery increases risk of major bleeding.
-Up to 11 days DVT prophylaxis was administered in trials.
-For hip fracture surgery, extending prophylaxis up to 24 additional days is recommended; a total of 32 days (perioperative and extended prophylaxis) was administered in trials.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, or knee replacement surgery.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery:

2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days

Comments:
-Administration earlier than 6 hours after surgery increases risk of major bleeding.
-Up to 11 days DVT prophylaxis was administered in trials.
-For hip fracture surgery, extending prophylaxis up to 24 additional days is recommended; a total of 32 days (perioperative and extended prophylaxis) was administered in trials.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, or knee replacement surgery.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery:

2.5 mg subcutaneously once a day after hemostasis is established, starting no sooner than 6 to 8 hours after surgery
Duration of therapy: 5 to 9 days

Comments:
-Administration earlier than 6 hours after surgery increases risk of major bleeding.
-Up to 11 days DVT prophylaxis was administered in trials.
-For hip fracture surgery, extending prophylaxis up to 24 additional days is recommended; a total of 32 days (perioperative and extended prophylaxis) was administered in trials.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, or knee replacement surgery.

What other drugs will affect fondaparinux?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with fondaparinux, especially other medicines used to treat or prevent blood clots, such as:

  • abciximab, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban;

  • alteplase, reteplase, tenecteplase, urokinase;

  • apixaban, argatroban, bivalirudin, dabigatran, desirudin, lepirudin, rivaroxaban; or

  • dalteparin, enoxaparin, heparin, tinzaparin.

This list is not complete. Other drugs may interact with fondaparinux, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about fondaparinux.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.08. Revision Date: 2014-08-28, 2:30:36 PM.

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