fondaparinux

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 medication if you are allergic to fondaparinux, heparin, or pork products, or if you have active 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 while using fondaparinux.

Tell any doctor who treats you that you are using fondaparinux. If you need anesthesia for a medical procedure or surgery, you may need to stop using the medicine for a short time.

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

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Fondaparinux may cause you to bleed more easily, especially if you have: a bleeding disorder, hemorrhagic stroke, eye problems caused by diabetes, uncontrolled high blood pressure, stomach or intestinal bleeding or ulcer, recent brain or spine surgery, recent eye surgery, or if you are an older adult who has kidney problems.

Fondaparinux can cause a very serious blood clot around your brain or 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, or if you are using other medications to treat or prevent blood clots. Symptoms of this type of blood clot include numbness, tingling, muscle weakness, or loss of movement.

Blood clots around the brain or spinal cord may occur during a spinal tap or epidural if you are using fondaparinux with other drugs that can affect blood clotting, including aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as Advil or Motrin, and any other medications to treat or prevent blood clots.

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding or life-threatening blood clots, and it is very important to tell your doctor about all medicines you have recently used.

Tell your caregivers at once if you have signs of bleeding such as black or bloody stools, coughing up blood, confusion, feeling like you might pass out, or any bleeding that will not stop.

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

You should not use this medication if you are allergic to fondaparinux, heparin, or pork products, or if you have:

• active or uncontrolled bleeding;

• severe kidney disease;

• 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; or

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

Fondaparinux can cause a very serious blood clot around your brain or 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;

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

• if you are using other medications 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. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use fondaparinux?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Fondaparinux is usually given every day until your bleeding condition improves. Follow the directions on your prescription label.

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 the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

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. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). 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.

To be sure this medication is not causing harmful effects, your blood and your stool (bowel movement) may need to be tested often. Your nerve and muscle function may also need to be tested. Visit your doctor regularly.

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.

Stop using fondaparinux and call your doctor at once if you have a serious side effect such as:

• 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;

• numbness, tingling, or muscle weakness (especially in your legs and feet);

• loss of movement in any part of your body;

• 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).

Less serious 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: fondaparinux side effects (in more detail)

Fondaparinux Dosing Information

Usual Adult Dose for Deep Vein Thrombosis:

less than 50 kg:
5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

50 to 100 kg:
7.5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

100 or more kg:
10 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

Treatment should be continued for a least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2.0 to 3.0). Concomitant treatment with warfarin should be initiated as soon as possible, usually within 72 hours. The usual duration of therapy is 5 to 9 days, although up to 26 days of therapy has been given.

Usual Adult Dose for Pulmonary Embolism:

less than 50 kg:
5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

50 to 100 kg:
7.5 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

100 or more kg:
10 mg administered by subcutaneous injection once daily given in conjunction with warfarin sodium therapy.

Treatment should be continued for a least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2.0 to 3.0). Concomitant treatment with warfarin should be initiated as soon as possible, usually within 72 hours. The usual duration of therapy is 5 to 9 days, although up to 26 days of therapy has been given.

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

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing abdominal surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 10 days of therapy has been administered.

Usual Adult Dose for Deep Vein Thrombosis -- Prophylaxis:

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of therapy is 5 to 9 days, and up to 11 days therapy has been tolerated. In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (perioperative and extended prophylaxis) has been tolerated.

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

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of therapy is 5 to 9 days, and up to 11 days therapy has been tolerated. In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (perioperative and extended prophylaxis) has been tolerated.

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

less than 50 kg:
Fondaparinux prophylactic therapy is contraindicated for use in patients weighing less than 50 kg undergoing hip fracture, hip replacement or knee replacement surgery.

50 or more kg:
2.5 mg subcutaneously once a day. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of therapy is 5 to 9 days, and up to 11 days therapy has been tolerated. In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (perioperative and extended prophylaxis) has been tolerated.

What other drugs will affect fondaparinux?

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding, or your risk of developing blood clots around the brain or spinal cord during a spinal tap or epidural. It is very important to tell your doctor about all medicines you have recently used, especially:

• dextran (Gentran, Hyskon);

• abciximab (ReoPro), eptifibatide (Integrilin), ticagrelor (Brilinta), tirofiban (Aggrastat);

• alteplase (Activase), reteplase (Retavase), tenecteplase (TNKase), urokinase (Abbokinase);

• anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eltrombopag (Promacta), oprelvekin (Neumega), prasugrel (Effient), romiplostim (Nplate), ticagrelor (Brilinta), ticlopidine (Ticlid);

• argatroban (Acova), bivalirudin (Angiomax), dabigatran (Pradaxa), lepirudin (Refludan);

• dalteparin (Fragmin), enoxaparin (Lovenox), rivaroxaban (Xarelto), heparin, tinzaparin (Innohep), warfarin (Coumadin, Jantoven);

• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

• salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

This list is not complete and other drugs may interact with fondaparinux. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about fondaparinux.