Fondaparinux contraindications: Difference between revisions

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'''Fondaparinux sodium''' (Arixtra) Injection is contraindicated in patients with severe [[renal impairment]] ([[creatinine clearance]] <30 mL/min). Fondaparinux sodium (Arixtra) is eliminated primarily by the kidneys, and such patients are at increased risk for major bleeding episodes.
'''Fondaparinux sodium''' (Arixtra) Injection is contraindicated in patients with severe [[renal impairment]] ([[creatinine clearance]] <30 mL/min). Fondaparinux sodium (Arixtra) is eliminated primarily by the kidneys, and such patients are at increased risk for major bleeding episodes.


Fondaparinux sodium (Arixtra) prophylactic therapy is contraindicated in patients with body weight <50 kg undergoing hip fracture, hip replacement or knee replacement surgery, and abdominal surgery. During the randomized clinical trials of prophylaxis in the peri-operative period following hip fracture, hip replacement, or knee replacement surgery, occurrence of major bleeding was doubled in patients with a body weight <50 kg compared with those with a body weight ≥50 kg (5.4% versus 2.1%). In the clinical trial in patients undergoing abdominal surgery, the major bleeding rate was also higher in patients with a body weight <50 kg as compared to those with a body weight ≥50 kg (5.3% versus 3.3%), respectively.
Fondaparinux sodium (Arixtra) prophylactic therapy is contraindicated in patients with body weight <50 kg undergoing [[hip fracture]], [[hip replacement]] or [[knee replacement]] surgery, and [[abdominal surgery]]. During the randomized clinical trials of prophylaxis in the peri-operative period following [[hip fracture]], [[hip replacement]], or [[knee replacement]] surgery, occurrence of major bleeding was doubled in patients with a body weight <50 kg compared with those with a body weight ≥50 kg (5.4% versus 2.1%). In the clinical trial in patients undergoing [[abdominal surgery]], the major bleeding rate was also higher in patients with a body weight <50 kg as compared to those with a body weight ≥50 kg (5.3% versus 3.3%), respectively.


The use of Fondaparinux sodium (Arixtra) is contraindicated in patients with active major bleeding, [[bacterial endocarditis]], in patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium, or in patients with known hypersensitivity to fondaparinux sodium.
The use of Fondaparinux sodium (Arixtra) is contraindicated in patients with active major bleeding, [[bacterial endocarditis]], in patients with [[thrombocytopenia]] associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium, or in patients with known hypersensitivity to fondaparinux sodium.





Revision as of 19:27, 14 February 2009

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


Contraindications

Fondaparinux sodium (Arixtra) Injection is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min). Fondaparinux sodium (Arixtra) is eliminated primarily by the kidneys, and such patients are at increased risk for major bleeding episodes.

Fondaparinux sodium (Arixtra) prophylactic therapy is contraindicated in patients with body weight <50 kg undergoing hip fracture, hip replacement or knee replacement surgery, and abdominal surgery. During the randomized clinical trials of prophylaxis in the peri-operative period following hip fracture, hip replacement, or knee replacement surgery, occurrence of major bleeding was doubled in patients with a body weight <50 kg compared with those with a body weight ≥50 kg (5.4% versus 2.1%). In the clinical trial in patients undergoing abdominal surgery, the major bleeding rate was also higher in patients with a body weight <50 kg as compared to those with a body weight ≥50 kg (5.3% versus 3.3%), respectively.

The use of Fondaparinux sodium (Arixtra) is contraindicated in patients with active major bleeding, bacterial endocarditis, in patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium, or in patients with known hypersensitivity to fondaparinux sodium.



Adapted from the FDA Package Insert.