Fondaparinux Sodium side effects and
warning (marketed as Arixtra)
zhion@zhion.com   November 2005
Arixtra Injection
Brand Name: Arixtra
Active Ingredient:   fondaparinux sodium
Strength(s):  2.5 mg/0.5 mL
Dosage Form(s):   Sucutaneous Injection
Company Name:    Fonda BV
Availability:         Prescription only, professional use only
*Date Approved by the FDA:   December 7, 2001
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What is Arixtra used for?
Arixtra is used to reduce the risk of blood clots in the deep veins of the legs and thighs.  These
clots may break off and travel to the lungs (pulmonary embolism).  Patients at risk for these
complications include those undergoing:

hip fracture surgery,
hip replacement surgery,
knee replacement surgery,
abdominal surgery who are already at risk of blood clot complications
Arixtra also is used with warfarin to treat:

·         blood clots in the veins

·         blood clots  that have broken off and traveled to the lungs (pulmonary embolism) when
the patient is first treated in the hospital

Who should not be given Arixtra?
Arixtra should not be given to patients who:
have severe kidney problems
weigh less than 110 pounds (50kg)
have bleeding anywhere
have a heart infection (bacterial endocarditis)
have a history of Arixtra causing the blood to have low platelets (thrombocytopenia)
are allergic to Arixtra or to any of the ingredients in Arixtra
Tell your healthcare provider if you have any of these conditions.

Special Warning(s) with Arixtra:
Arixtra and other medicines like it can cause bleeding into the spine when used in patients
who have received epidural or spinal anesthesia, or any spinal injection. Bleeding in the spine
can cause long term or permanent paralysis.

Arixtra, like other medicines that prevent the blood from clotting, is given with extreme caution
to people who have conditions that have an increased risk of bleeding, such as:

bleeding disorders
ulcerative colitis and other bleeding disorders in the stomach and intestines
bleeding into the brain (hemorrhagic stroke)
recent brain, spinal, or eye surgery
taking other medicines that prevent the blood from clotting

General Precautions with Arixtra:
Certain other medicines can increase the risk of bleeding with Arixtra. Tell your healthcare
provider about all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Especially, tell your health care provider if you
are taking:

blood thinners
aspirin
non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin) or naproxen sodium
(Naprosyn or Aleve)
What should I tell my doctor or healthcare provider?

Tell your healthcare provider if you have:
bleeding problems, any recent bleeding, or if you bleed easily
high blood pressure
a recent stomach ulcer
eye problems due to diabetes
kidney problems
had a stroke

What are some possible side effects of Arixtra? (This list is NOT a complete list of side
effects reported with Arixtra. Your healthcare provider can discuss with you a more complete
list of side effects.)

The most common side effect with Arixtra is bleeding.

For more detailed information about Arixtra, ask your healthcare provider.
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