Fondaparinux

>10%

Anemia (1-20%)

Fever (4-14%)

Nausea (3-11%)

1-10%

Rash (7.5%)

Dizziness (4%)

Confusion (3%)

Constipation (5-9%)

Diarrhea (2-3%)

Edema (9%)

Headache (2-5%)

Hypokalemia (1-4%)

Hypotension (4%)

Insomnia (4-5%)

Purpura (4%)

Thrombocytopenia (3%)

Urinary retention (3%)

Urinary tract infection (2-4%)

Vomiting (1-6%)

Postmarketing Reports

Thrombocytopenia with thrombosis that manifested similarly to HIT

Serious allergic reactions, including angioedema and anaphylactoid or anaphylactic reactions

Spinal or epidural hematomas

Hemorrhage

Increase in bleeding risk with renal impairment

Increase in bleeding risk with body weight <50 Kg

Increase in aminotransferase levels

Fondaparinux is a prescription medication used to treat and prevent blood clots. Fondaparinux, a "blood thinner", belongs to a group of drugs called factor Xa (ten A) inhibitor anticoagulants. These medications work by decreasing the ability of blood to form clots.

Fondaparinux comes in an injectable form and is given by injection under the skin once daily.  

• Store fondaparinux at room temperature 59°F to 86°F (15°C to 30°C). Do not freeze.
• Safely, throw away fondaparinux that is out of date or no longer needed.
• Keep fondaparinux and all medicines out of the reach of children.

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

• If you have an allergy to fondaparinux or any other part of fondaparinux.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you weigh less than 110 pounds (50 kilograms).
• If you have a low platelet count, talk with your doctor.
• If you have any of these health problems: Bleeding, a heart infection called endocarditis, or poor kidney function.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take fondaparinux with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous, as sodium:

Generic: 2.5 mg/0.5 mL (0.5 mL); 5 mg/0.4 mL (0.4 mL); 7.5 mg/0.6 mL (0.6 mL); 10 mg/0.8 mL (0.8 mL)

Solution, Subcutaneous, as sodium [preservative free]:

Arixtra: 2.5 mg/0.5 mL (0.5 mL); 5 mg/0.4 mL (0.4 mL); 7.5 mg/0.6 mL (0.6 mL); 10 mg/0.8 mL (0.8 mL)

Generic: 2.5 mg/0.5 mL (0.5 mL); 5 mg/0.4 mL (0.4 mL); 7.5 mg/0.6 mL (0.6 mL); 10 mg/0.8 mL (0.8 mL)

Elimination is prolonged.

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.

CrCl less than 30 mL/min: Contraindicated
CrCl 30 to 50 mL/min: Use with caution

Discontinue immediately if patient develops severe renal impairment.

CrCl less than 30 mL/min: Contraindicated
CrCl 30 to 50 mL/min: Use with caution

Discontinue immediately if patient develops severe renal impairment.

Clearance may be increased by up to 20% during chronic intermittent hemodialysis.