Fondaparinux

What is Fondaparinux?

• Fondaparinux (Arixtra) is a Factor Xa inhibitor (anticoagulant) used to prevent deep vein thrombosis, which can lead to pulmonary embolism, in people who are having hip surgery, hip or knee replacement, or abdominal surgery.
• It is also used in along with warfarin used for treatment of DVT or acute pulmonary embolism (PE).

Fondaparinux

What are the uses of this medicine?

Fondaparinux (Arixtra) is a prescription medicine that is used to:

• help prevent blood clots from forming in people 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 along with the blood thinner medicine warfarin.

How does this medicine work?

• Fondaparinux (fon" da par' in ux) is a synthetic inhibitor of factor Xa which blocks the activity of this clotting factor indirectly by binding to and activating antithrombin III.
• Fondaparinux is composed of five monomeric sugars that are identical to the sequence present in heparin that comprises the high affinity binding site for antithrombin III.
• Unlike standard and low molecular weight heparins, however, fondaparinux is specific for factor Xa and has no effect on thrombin or other clotting factors.
• As a result, fondaparinux has a more predictable and reproducible anticoagulant effect and can be administered in a fixed dose once daily and does not require monitoring for anticoagulant effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have certain kidney problems
• have active bleeding problems
• have an infection in your heart
• have low platelet counts and if you test positive for a certain antibody while you are taking fondaparinux sodium injection
• weigh less than 110 pounds (50 kg) to prevent blood clots from surgery
• had a serious allergic reaction to fondaparinux sodium injection

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin), anagrelide (Agrylin), aspirin or nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), eptifibatide (Integrilin), prasugrel (Effient), ticlopidine, and tirofiban (Aggrastat).

Is this medicine FDA approved?

• Fondaparinux was approved for use in the United States in 2001 and current indications include prevention of deep vein thrombosis in high risk individuals (such as after surgery or during immobilization) and active treatment of deep vein thrombosis with or without pulmonary embolism (in combination with warfarin).
• Fondaparinux is available as solution for injection in prefilled syringes generically and under the brand name Arixtra.

How should this medicine be used?

Recommended dosage: As Prophylaxis of deep vein thrombosis:

• Fondaparinux sodium 2.5 mg subcutaneously once daily after hemostasis has been established.
• The initial dose should be given no earlier than 6 to 8 hours after surgery and continued for 5 to 9 days.
• For patients undergoing hip fracture surgery, extended prophylaxis up to 24 additional days is recommended.

For Treatment of deep vein thrombosis and pulmonary embolism:

• Fondaparinux sodium 5 mg (body weight <50 kg), 7.5 mg (50 to 100 kg), or 10 mg (>100 kg) subcutaneously once daily.
• Treatment should continue for at least 5 days until INR 2 to 3 achieved with warfarin sodium.

Administration:

• Fondaparinux injection comes as a solution.
• Fondaparinux sodium is injected into a skin fold of the lower stomach area (abdomen).
• It is usually given one time a day for 5 to 9 days or sometimes for up to about 1 month.
• You will probably begin using fondaparinux injection while you are in the hospital at least 6 to 8 hours after your surgery.
• Do not inject 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.
• If your doctor tells you that you may give yourself injections of fondaparinux sodium at home, you will be shown how to give the injections first before you do them on your own.
• Take fondaparinux sodium injection exactly as your doctor tells you to. Fondaparinux sodium is given by injection under the skin (subcutaneous injection).
• If you miss a dose of fondaparinux sodium injection, take your dose as soon as you remember. Do not take 2 doses at the same time. ·
• If you take too much fondaparinux sodium injection, call your doctor right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: Single-dose, prefilled syringes containing 2.5 mg, 5 mg, 7.5 mg, or 10 mg of fondaparinux sodium.

This medicine is available in fallowing brand namesː

• Arixtra

What side effects can this medication cause?

The most common side effects of this medicine include:

• bleeding problems
• bleeding, rash, and itching at the injection site (injection site reactions)
• sleep problems (insomnia)
• low red blood cell count (anemia)
• increased wound drainage
• low potassium in your blood (hypokalemia)
• dizziness
• purplish spots on skin (purpura)
• low blood pressure (hypotension)
• confusion
• fluid-filled blisters (bullous eruption)
• blood clots (hematoma)
• severe bleeding after surgery (post-operative hemorrhage)

Fondaparinux sodium injection may cause serious side effects, including:

• hematoma
• Severe bleeding
• Certain kidney problems can also increase your risk of bleeding with fondaparinux sodium injection
• Increased bleeding risk in people undergoing certain surgeries who weigh less than 110 pounds (50 kg)
• thrombocytopenia

What special precautions should I follow?

• Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur. If the patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDS, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematomas, such as back pain, tingling, numbness (especially in the lower limbs), muscular weakness, and stool or urine incontinence. If any of these symptoms occur, the patients should contact his or her physician immediately.
• Fondaparinux sodium increases the risk of hemorrhage in patients at risk for bleeding. The use of aspirin and other NSAIDS may enhance the risk of hemorrhage. Their use should be discontinued prior to fondaparinux sodium therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored.
• Fondaparinux sodium increases the risk of bleeding in patients with impaired renal function due to reduced clearance. Assess renal function periodically in patients receiving fondaparinux sodium. Discontinue the drug immediately in patients who develop severe renal impairment while on therapy.
• After discontinuation of fondaparinux sodium, its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). The anticoagulant effects of fondaparinux sodium may persist even longer in patients with renal impairment.
• Fondaparinux sodium increases the risk for bleeding in patients who weigh less than 50 kg, compared to patients with higher weights.
• Thrombocytopenia can occur with the administration of fondaparinux sodium.
• Periodic routine complete blood counts (including platelet counts), serum creatinine level, and stool occult blood tests are recommended.
• If patients must self-administer fondaparinux sodium (e.g., if fondaparinux sodium is used at home), they should be advised of the following:
• Fondaparinux sodium should be given by subcutaneous injection. Patients must be instructed in the proper technique for administration
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fondaparinux injection.
• Fondaparinux has been associated with a low rate of serum aminotransferase elevations during therapy, but has not been implicated in cases of clinically apparent, idiosyncratic liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hemorrhagic complications

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Discontinue treatment and initiate appropriate therapy if bleeding complications associated with overdosage occur.
• Clearance of fondaparinux sodium can increase by 20% during hemodialysis.

Can this medicine be used in pregnancy?

• Use of anticoagulants, including fondaparinux sodium, may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding.
• Fondaparinux sodium injection may harm your unborn baby.
• If you are pregnant, talk to your doctor about the best way for you to prevent or treat blood clots.

Can this medicine be used in children?

• Safety and effectiveness of fondaparinux sodium in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: fondaparinux sodium
• Inactive Ingredients: sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.

Who manufactures and distributes this medicine?

Mfd. By:

• Dr. Reddy's Laboratories Ltd.
• At D.P. Pally , INDIA

What should I know about storage and disposal of this medication?

• Store fondaparinux sodium injection at 20° to 25°C (68° to 77°F).
• Safely, throw away fondaparinux sodium injection that is out of date or no longer needed.

• Dailymed label info on Fondaparinux
• FDA Fondaparinux

Fondaparinux Resources
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