Fondaparinux

DRUG INFORMATION

  ADULT
    - ( 2.1 ) Prophylaxis of deep vein thrombosis: fondaparinux sodium 2.5 mg
      subcutaneously once daily after hemostasis has been established.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 , 2.3 ) Treatment of deep vein thrombosis and pulmonary
      embolism:fondaparinux sodium 5 mg (body wright < 50 kg), 7.5mg (50 to 100 kg), or
      100 mg (>100 kg) subcutaneously once daily.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - Discard unused portion. 2.2 Deep Vein Thrombosis Prophylaxis Following Hip
      Fracture, Hip Replacement, and Knee Replacement Surgery In patients undergoing hip
      fracture, hip replacement, or knee replacement surgery, the recommended dose of
      fondaparinux sodium injection is 2.5 mg administered by subcutaneous injection
      once daily after hemostasis has been established.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of fondaparinux sodium in pediatric patients have not
      been established. Because risk for bleeding during treatment with fondaparinux
      sodium is increased in adults who weigh <50 kg, bleeding may be a particular
      safety concern for use of fondaparinux sodium in the pediatric population [see
      Warnings and Precautions ( 5.4 )].
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Discontinue fondaparinux sodium immediately in patients who develop severe renal
      impairment while on therapy.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - The anticoagulant effects of fondaparinux sodium may persist even longer in
      patients with renal impairment [see Clinical Pharmacology ( 12.4 )]. 8.7 Hepatic
      Impairment Following a single, subcutaneous dose of 7.5 mg of fondaparinux sodium
      in patients with moderate hepatic impairment (Child-Pugh Category B) compared to
      subjects with normal liver function, changes from baseline in aPTT, PT/INR, and
      antithrombin III were similar in the two groups.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'use in
      specific populations', retrieved 2026-08-29
    - ( 5.2 ) Bleeding risk is increased in renal impairment and in patients with low
      body weight <50 kg.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'warnings and
      cautions', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - The usual duration of administration of fondaparinux sodium injection is 5 to 9
      days; up to 26 days of fondaparinux sodium injection was administered in clinical
      trials. [See Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6 ), and
      Clinical Studies ( 14 ).] 2.5 Hepatic Impairment No dose adjustment is recommended
      in patients with mild to moderate hepatic impairment, based upon single-dose
      pharmacokinetic data.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - Pharmacokinetic data are not available for patients with severe hepatic
      impairment.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'dosage and
      administration', retrieved 2026-08-29
    - Patients with hepatic impairment may be particularly vulnerable to bleeding during
      fondaparinux sodium therapy.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available data from published literature and postmarketing reports
      have not reported a clear association with fondaparinux sodium and adverse
      development outcomes.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'pregnancy',
      retrieved 2026-08-29
    - 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) .
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'pregnancy',
      retrieved 2026-08-29
    - 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) .
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary There are no data on the presence of fondaparinux sodium in human
      milk, or the effects on milk production.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'nursing
      mothers', retrieved 2026-08-29
    - Limited clinical data during lactation preclude a clear determination of the risk
      of fondaparinux sodium to an infant during lactation; therefore, the developmental
      and health benefits of breastfeeding should be considered along with mother’s
      clinical need for fondaparinux sodium and any potential adverse effects on the
      breastfed infant from fondaparinux sodium or from the underlying maternal
      condition.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'nursing
      mothers', retrieved 2026-08-29
    - Additionally, there were no effects on pre and postnatal development in a study
      conducted in rats at subcutaneous dose up to 10 mg/kg/day (about 32 times the
      recommended human dose based on body surface area) 8.2 Lactation Risk Summary
      There are no data on the presence of fondaparinux sodium in human milk, or the
      effects on milk production.
      Source: US FDA label for fondaparinux (fondaparinux sodium), section 'use in
      specific populations', retrieved 2026-08-29