Fondaparinux

What it is used for

Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin.

( 1.2, 1.3 ) 1.1 Prophylaxis of Deep Vein Thrombosis Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing hip fracture surgery, including extended prophylaxis; in patients undergoing hip replacement surgery; in patients undergoing knee replacement surgery; in patients undergoing abdominal surgery who are at risk for thromboembolic complications.

1.2 Treatment of Acute Deep Vein Thrombosis Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. 1.3 Treatment of Acute Pulmonary Embolism Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

How to take it

• See the detailed Instructions for Use that comes with fondaparinux sodium for information about to give a fondaparinux sodium injection.
• 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.
• Tell your doctor if you have any bleeding or bruising while taking fondaparinux sodium 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.

Side effects, and when to stop

Fondaparinux sodium can cause serious side effects.

• Severe bleeding. Certain conditions can increase your risk for severe bleeding, including: -some bleeding problems -some gastrointestinal problems including ulcers -some types of strokes -uncontrolled high blood pressure -diabetic eye disease -soon after brain, spine, or eye surgery
• Certain kidney problems can also increase your risk of bleeding with fondaparinux sodium injection. Your doctor may check your kidney function during your treatment with fondaparinux sodium injection.
• Increased bleeding risk in people undergoing surgery who weigh less than 110 pounds.
• Low blood platelets (thrombocytopenia). Low blood platelets can happen when you take fondaparinux sodium injection. Platelets are blood cells that help your blood to clot normally. Your doctor may check your platelet counts during your treatment with fondaparinux sodium injection.

You may bruise or bleed more easily during your treatment with fondaparinux sodium injection, and it may take longer than usual for bleeding to stop. Tell your doctor if you have any signs or symptoms of bleeding, bruising or rash of dark red spots under the skin during your treatment with fondaparinux sodium injection.

Tell your doctor if you have any signs or symptoms of bleeding, bruising or rash of dark spots under the skin (thrombocytopenia).

The most common side effects of fondaparinux sodium injection include:

• bleeding problems
• bleeding, rash, and itching at the injection site (injection site reactions)
• sleep problems (insomnia)
• low red blood cell counts (anemia)
• incleased 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)

These are not all the possible side effects of fondaparinux sodium injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What to say before you start

Before taking fondaparinux sodium injection, tell your doctor about all of your medical conditions, including if you:

• have had any bleeding problems (such as stomach ulcers)
• have had a stroke
• have had recent surgeries, including eye surgery
• have diabetic eye disease
• have kidney or liver problems
• have uncontrolled high blood pressure
• have a latex allergy. The packaging (needle guard) for fondaparinux sodium injection contains dry natural latex rubber.
• are pregnant or plan to become pregnant. Fondaparinux sodium 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.
• are breast-feeding or plan to breastfeed. It is not known if fondaparinux sodium injection passes into breast milk. You and your doctor should decide if you will breastfeed during treatment with fondaparinux sodium.

Tell your doctor about all the medicines you take including prescriptions and over-the-counter medicines, vitamins, and herbal supplements. Some medicines can increase your risk of bleeding.

Do not start taking any new medicines without first talking to your doctor.

Tell all your doctors and dentist that you take fondaparinux sodium injection, especially if you need to have any kind of surgery or a dental procedure. Keep a list of your medicines and show it to all your doctors and pharmacist before you start a new medicine.

Storing it

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

Keep fondaparinux sodium injection and all medicines out of the reach of children.

General information about the safe and effective use of fondaparinux sodium injection

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use fondaparinux sodium injection for a condition for which it was not prescribed. Do not give fondaparinux sodium injection to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about fondaparinux sodium injection that is written for healthcare professionals.