Arixtra Injection®




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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, 2021
*Approval by FDA does not mean that the drug is
available for consumers at this time.



What is Arixtra used for? 

Arixtra is used to reduce the risk of blood clots in the veins, which
may break off and travel to the lungs (pulmonary embolism) in patients
undergoing:

  • hip fracture surgery,
  • hip replacement surgery,
  • knee replacement surgery.

Who should not be given Arixtra?

Arixtra should not be given to people 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 health care provider if you have any of these conditions.

Special Warnings 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 doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your doctor or health care provider if you are taking: 

  • blood thinners 
  • aspirin 
  • non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin), naproxen sodium (Naprosyn or Aleve) 

What should I tell my health care provider?

Tell your health care 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
health care 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 health care
provider or pharmacist.

http://www.fda.gov/cder/foi/nda/2001/21-345_Arixtra.htm   Arixtra’s labeling

Posted: 11/22/02

 

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source: FDA




last update: December 2004