아릭스트라주(폰다파리눅스나트륨)

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. ( 1.1 ) 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.

Fondaparinux sodium injection is contraindicated in the following conditions:( 4 ) Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [See Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 ).] Active major bleeding. Bacterial endocarditis. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium. Body weight <50 kg (venous thromboembolism [VTE] prophylaxis only) [see Warnings and Precautions ( 5.4 )]. History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/ anaphylactic reactions) to fondaparinux sodium injection. Fondaparinux sodium injection is contraindicated in the following conditions: ( 4 ) Severe renal impairment (creatinine clearance <30 mL/min) in prophylaxis or treatment of venous thromboembolism. Active major bleeding. Bacterial endocarditis. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of …

Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur. ( 5.1 ) Patient taking fondaparinux sodium with risk factors for bleeding are at increased risk of hemorrhage. ( 5.2 ) Bleeding risk is increased in renal impairment and in patients with low body weight <50 kg. ( 5.3 , 5.4 ) Thrombocytopenia can occur with administration of fondaparinux sodium. ( 5.5 ) Periodic routine complete blood counts (including platelet counts), serum creatinine level, and stool occult blood tests are recommended ( 5.6 ) The packaging (needle guard) contains dry natural rubber and may cause allergic reactions in latex sensitive individuals ( 5.7 ) 5.1 Neuraxial Anesthesia and Post-operative Indwelling Epidural Catheter Use Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur with the use of anticoagulants and neuraxial (spinal/epidural) anesthesia or spinal puncture. The risk of these events may be higher with post-operative use of indwelling epidural catheters or concomitant use of other drugs affecting hemostasis such as NSAIDs [see Boxed Warning]. In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of fondaparinux sodium by subcutaneous (SC) injection. Optimal timing between the administration of fondaparinux sodium and neuraxial procedures is not known. Monitor patients undergoing these procedures for signs and symptoms of neurologic impairment such as midline …

8.1 Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with fondaparinux sodium and adverse development outcomes. Fondaparinux sodium plasma concentrations obtained from four women treated with fondaparinux sodium during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium (see Data) . There are risk to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants (see Clinical Consideration) . In animal reproduction studies, there was no evidence of adverse developmental …