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FONDAPARINUX

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Fondaparinux is a synthetic and specific inhibitor of activated factor Xa (anticoagulant).

Specific Substances

    1) Fondaparinux sodium
    2) Fondaparin sodium
    3) Fondaparinuxnatrium
    4) Fondaparinuxum
    5) Org-31540
    6) SR-90107A
    7) CAS 114870-03-0
    1.2.1) MOLECULAR FORMULA
    1) C31-H43-N3-Na10-O49-S8

Available Forms Sources

    A) FORMS
    1) Fondaparinux is available in the United States as single-dose, prefilled syringes containing 2.5 mg, 5 mg, 7.5 mg, or 10 mg of fondaparinux (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    B) USES
    1) Fondaparinux is used for the following indications: prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery; treatment of DVT or acute pulmonary embolism when administered with warfarin (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Fondaparinux is used for the prophylaxis of deep vein thrombosis (DVT) and for the treatment of DVT and pulmonary embolism when administered with warfarin.
    B) PHARMACOLOGY: Fondaparinux sodium is an antithrombotic drug that selectively binds to antithrombin III (ATIII), thereby potentiating the innate neutralization of Factor Xa. Neutralization of Factor Xa disrupts the blood coagulation cascade, which inhibits thrombin formation and thrombus development. Fondaparinux has no known effect on platelet function, and does not inactivate thrombin; therefore, it does not affect bleeding time or fibrinolytic activity at the recommended dose.
    C) TOXICOLOGY: Excessive neutralization of factor Xa may cause clinically significant bleeding.
    D) EPIDEMIOLOGY: Overdose is rare.
    E) WITH THERAPEUTIC USE
    1) The main complication of fondaparinux therapy is bleeding. The following adverse effects have also been reported: edema, hypotension, rash, nausea, vomiting, constipation, anemia, hypokalemia, purpura, increased liver enzymes, insomnia, dizziness, confusion, fever, and injection site reactions. Thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported in a small number of patients during postmarketing surveillance of fondaparinux.
    F) WITH POISONING/EXPOSURE
    1) TOXICITY: Overdose effects are anticipated to be an extension of adverse effects observed following therapeutic doses. The main effect of fondaparinux overdose is hemorrhage.
    0.2.3) VITAL SIGNS
    A) WITH THERAPEUTIC USE
    1) Fever has been reported in patients receiving fondaparinux.
    0.2.20) REPRODUCTIVE
    A) Fondaparinux is classified as FDA pregnancy category B. Animal studies found no evidence of impaired fertility or fetal harm with fondaparinux.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, the manufacturer does not report any carcinogenic potential for fondaparinux sodium in humans.

Laboratory Monitoring

    A) Monitor for evidence of bleeding (eg, venous access sites, urinary, gastrointestinal, vaginal).
    B) Monitor CBC with platelet count, vital signs, and hepatic enzymes in symptomatic patients.
    C) aPTT and INR are relatively insensitive in measuring the activity of fondaparinux at therapeutic doses, but may be prolonged after overdose.
    D) Plasma anti-factor Xa concentrations can be measured, but results are generally not available rapidly enough to use this to guide therapy.

Treatment Overview

    0.4.6) PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive. Monitor for potential bleeding. Manage mild hypotension with IV fluids. If hypotension persists, treat patients with vasopressors.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Transfusion of packed red cells, fresh frozen plasma, or administration of recombinant factor VIIa may be indicated in patients with severe bleeding. Treat severe hypotension with fluids and vasopressors if necessary.
    C) DECONTAMINATION
    1) Decontamination is not indicated; fondaparinux is only available parenterally.
    D) AIRWAY MANAGEMENT
    1) Assess airway; endotracheal intubation may be required in patients with intracranial bleeding or severe hemoptysis.
    E) ANTIDOTE
    1) Protamine sulfate has not been effective for neutralizing the anticoagulant effects of fondaparinux. Recombinant factor VIIa may be effective in reversing the uncontrollable bleeding following an fondaparinux overdose.
    F) ENHANCED ELIMINATION
    1) Hemodialysis and hemoperfusion are UNLIKELY to be of value because of the high degree of protein binding and large volume of distribution; and the anticoagulation necessary to perform these techniques would likely increase bleeding.
    G) PATIENT DISPOSITION
    1) OBSERVATION CRITERIA: All patients with fondaparinux overdose should be evaluated and monitored until symptoms resolve. Patients can be discharged when laboratory values are stable with no evidence of bleeding.
    2) ADMISSION CRITERIA: Patients with severe symptoms (eg, hemorrhage) should be admitted to an intensive care setting.
    H) PITFALLS
    1) When managing a suspected fondaparinux overdose, the possibility of multi-drug involvement should be considered.
    I) PHARMACOKINETICS
    1) Tmax, subQ: 3 hours; protein binding: 94%; volume of distribution: 7 to 11 L; renal excretion: 77% unchanged; elimination half-life: 17 to 21 hours.
    J) DIFFERENTIAL DIAGNOSIS
    1) Bleeding diathesis: Disseminated intravascular coagulation, Vitamin K deficiency, rattlesnake envenomation, congenital bleeding disorders (hemophilia, von Willebrand’s disease), or coumadin overdose. Thrombocytopenia: Caused by other drugs, vitamin B12 or folic acid deficiency, hereditary syndromes, leukemia. Hypotension: Hypovolemia (other causes), antihypertensive agents.

Range Of Toxicity

    A) TOXICITY: A minimum toxic dose has not been established.
    B) THERAPEUTIC DOSES: ADULTS: DVT PROPHYLAXIS, POSTOPERATIVE: 2.5 mg subQ once daily 6 to 8 hours after surgery and continued for 5 to 9 days; continue up to 24 additional days for extended prophylaxis in hip surgery. DVT/PULMONARY EMBOLISM TREATMENT: 5 mg to 10 mg subQ once daily for 5 to 9 days. CHILDREN: Safety and efficacy have not been established in pediatric patients.

Clinical Effects

Summary Of Exposure

    A) USES: Fondaparinux is used for the prophylaxis of deep vein thrombosis (DVT) and for the treatment of DVT and pulmonary embolism when administered with warfarin.
    B) PHARMACOLOGY: Fondaparinux sodium is an antithrombotic drug that selectively binds to antithrombin III (ATIII), thereby potentiating the innate neutralization of Factor Xa. Neutralization of Factor Xa disrupts the blood coagulation cascade, which inhibits thrombin formation and thrombus development. Fondaparinux has no known effect on platelet function, and does not inactivate thrombin; therefore, it does not affect bleeding time or fibrinolytic activity at the recommended dose.
    C) TOXICOLOGY: Excessive neutralization of factor Xa may cause clinically significant bleeding.
    D) EPIDEMIOLOGY: Overdose is rare.
    E) WITH THERAPEUTIC USE
    1) The main complication of fondaparinux therapy is bleeding. The following adverse effects have also been reported: edema, hypotension, rash, nausea, vomiting, constipation, anemia, hypokalemia, purpura, increased liver enzymes, insomnia, dizziness, confusion, fever, and injection site reactions. Thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported in a small number of patients during postmarketing surveillance of fondaparinux.
    F) WITH POISONING/EXPOSURE
    1) TOXICITY: Overdose effects are anticipated to be an extension of adverse effects observed following therapeutic doses. The main effect of fondaparinux overdose is hemorrhage.

Vital Signs

    3.3.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Fever has been reported in patients receiving fondaparinux.
    3.3.3) TEMPERATURE
    A) WITH THERAPEUTIC USE
    1) FEVER: Fever was reported in 13.6% of patients (n=3616) receiving fondaparinux (2.5 mg subQ once daily) during clinical trials (Prod Info ARIXTRA (R) subcutaneous injection, 2008).

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) EDEMA
    1) WITH THERAPEUTIC USE
    a) Edema was reported in 8.7% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616). The reported incidence was 0.9% when fondaparinux was administered for extended prophylaxis (n=327) (Prod Info ARIXTRA (R) subcutaneous injection, 2008).
    B) HYPOTENSIVE EPISODE
    1) WITH THERAPEUTIC USE
    a) Hypotension was reported in 3.5% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616). The reported incidence was 0.3% when fondaparinux was administered for extended prophylaxis (n=327) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) INSOMNIA
    1) WITH THERAPEUTIC USE
    a) Insomnia was reported in 5% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    B) DIZZINESS
    1) WITH THERAPEUTIC USE
    a) Dizziness was reported in 3.6% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    C) CLOUDED CONSCIOUSNESS
    1) WITH THERAPEUTIC USE
    a) Confusion was reported in 3.1% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) VOMITING
    1) WITH THERAPEUTIC USE
    a) Vomiting was reported in 5.9% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA (R) subcutaneous injection, 2008).
    B) NAUSEA
    1) WITH THERAPEUTIC USE
    a) Nausea was reported in 11.3% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA (R) subcutaneous injection, 2008).
    C) CONSTIPATION
    1) WITH THERAPEUTIC USE
    a) Constipation was reported in 8.5% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA (R) subcutaneous injection, 2008).

Hepatic

    3.9.2) CLINICAL EFFECTS
    A) INCREASED LIVER ENZYMES
    1) WITH THERAPEUTIC USE
    a) Asymptomatic and reversible elevations of aspartate (AST) and alanine (ALT) aminotransferase concentrations greater than 3 times the upper limit of normal were reported in 1.7% and 2.6% of patients, respectively (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) ANEMIA
    1) WITH THERAPEUTIC USE
    a) Anemia was reported in 19.6% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616). The reported incidence was 1.5% when fondaparinux was administered for extended prophylaxis (n=327) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    B) BLEEDING
    1) WITH THERAPEUTIC USE
    a) The main complication of fondaparinux therapy is bleeding. In clinical trials (n=3616), the risk of major and minor bleeding with fondaparinux were 2.7% and 3%, respectively. An increased risk of bleeding has also been associated with fondaparinux therapy in patients with a body weight below 50 kg (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    b) In a published phase II study involving total hip replacement patients, incidences of major bleeding with subQ fondaparinux tended to be dose-related, and were 0.5%, 4.5%, 16.7%, and 17.3% with 1.5, 3, 6, and 8 mg once daily, respectively. A dose-related effect was not seen for minor bleeding (2.7%, 3.4%, 2.8%, and 3.8% with these respective doses). Compared to subQ enoxaparin 30 mg twice daily, the incidence of major bleeding was more frequent with fondaparinux 6 and 8 mg daily, similar with fondaparinux 3 mg daily, and less frequent with fondaparinux 1.5 mg daily (Turpie et al, 2001). However, a dose-relationship was not observed for major bleeding episodes in patients receiving fondaparinux 5, 7.5, or 10 mg daily for established deep-vein thrombosis; incidences were 3.9%, 1.8%, and 0.8%, respectively. In this study, the incidence of major bleeding with dalteparin (100 units/kg twice daily) was 2.5%. Treatment with all agents was given for at least 5 days (Anon, 2000).
    2) WITH POISONING/EXPOSURE
    a) The main effect of fondaparinux overdose is hemorrhage (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    C) THROMBOCYTOPENIC DISORDER
    1) WITH THERAPEUTIC USE
    a) In clinical trials involving patients given fondaparinux 2.5 mg for hip fracture, hip replacement or knee replacement surgeries, the incidence of severe thrombocytopenia (platelet counts less than 50,000/mm(3)) was 0.2% and the incidence of moderate thrombocytopenia (platelet counts between 100,000 and 50,000/mm(3)) was 3%. During extended prophylaxis, no cases of moderate or severe thrombocytopenia were observed. During the deep vein thrombosis and pulmonary embolism treatment clinical trials, moderate thrombocytopenia occurred in 0.5% of patients and severe thrombocytopenia occurred in 0.04% of patients (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    b) Thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia heparin, have been reported in a small number of patients during postmarketing surveillance of fondaparinux (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    c) Fondaparinux does not form reactive complexes with platelet factor 4 and failed to bind antibodies developed in type II heparin-induced thrombocytopenia (HIT) in an ex vivo study (Amiral et al, 1997). However, clinical studies in this setting are lacking.
    D) PURPURA
    1) WITH THERAPEUTIC USE
    a) Purpura was reported in 3.5% of patients receiving fondaparinux sodium 2.5 mg subQ once daily for perioperative prophylaxis during clinical trials (n=3616) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).
    E) ACTIVATED PARTIAL THROMBOPLASTIN TIME ABNORMAL
    1) WITH THERAPEUTIC USE
    a) Rare cases of prolonged activated partial thromboplastin time (aPTT) associated with bleeding events have been reported during postmarketing surveillance of fondaparinux (with or without concomitant administration of other anticoagulants) (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) ERUPTION
    1) WITH THERAPEUTIC USE
    a) Rash was reported in 7.5% of patients (n=3616) receiving fondaparinux sodium (2.5 mg subQ once daily) during clinical trials (Prod Info ARIXTRA (R) subcutaneous injection, 2008).
    B) INJECTION SITE REACTION
    1) WITH THERAPEUTIC USE
    a) Injection site reactions including bleeding, rash, and pruritus may occur following subQ administration of fondaparinux (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Reproductive

    3.20.1) SUMMARY
    A) Fondaparinux is classified as FDA pregnancy category B. Animal studies found no evidence of impaired fertility or fetal harm with fondaparinux.
    3.20.2) TERATOGENICITY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the teratogenic potential of this agent (Prod Info ARIXTRA subcutaneous injection, 2011).
    B) LACK OF EFFECT
    1) CASE REPORT: A 24-year-old woman gave birth to a healthy infant at 37 weeks gestation following fondaparinux treatment for heparin-induced thrombocytopenia (HIT) that developed with therapy for acute pulmonary embolism (PE) at week 34. The patient was initially treated with an IV infusion of unfractionated heparin for 4 days followed by 2 days of enoxaparin, 1 mg/kg. Following a rapid decrease of her platelet count from a baseline of 200 x 10(9)/L to 44 x 10(9)/L, enoxaparin was discontinued and daily injections of fondaparinux 7.5 mg subQ were started; maternal platelet counts initially decreased to a low of 19 x 10(9)/L, then progressively increased after 10 days of therapy. Daily treatment continued with no bleeding or PE recurrence. Elective cesarean section with general anesthesia was scheduled for week 37 to address the risk of neonatal bleeding complications during delivery, and fondaparinux was interrupted 24 hours before the procedure in the event of transplacental exposure. No excessive bleeding occurred during the procedure, and the patient delivered a healthy 2620 g girl with a normal platelet count. Maternal fondaparinux and heparin therapy were restarted within 2 days of surgery. Both mother and infant were discharged in good condition 10 days after delivery (Ciurzynski et al, 2011).
    C) ANIMAL STUDIES
    1) RATS, RABBITS: Animal studies conducted in rats and rabbits using doses up to 10 mg/kg/day (32 and 65 times the recommended human dose based on body surface area, respectively) revealed no evidence of impaired fertility or fetal harm (Prod Info ARIXTRA subcutaneous injection, 2011).
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy in humans (Prod Info ARIXTRA subcutaneous injection, 2011).
    B) PREGNANCY CATEGORY
    1) The manufacturer has classified fondaparinux as FDA pregnancy category B (Prod Info ARIXTRA subcutaneous injection, 2011).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the potential effects of exposure to fondaparinux during lactation in humans (Prod Info ARIXTRA subcutaneous injection, 2011).
    B) ANIMAL STUDIES
    1) RATS: Animal studies have shown that fondaparinux is excreted into the milk of lactating rats (Prod Info ARIXTRA subcutaneous injection, 2011).
    3.20.5) FERTILITY
    A) ANIMAL STUDIES
    1) RATS: Fondaparinux was found to have no effect on fertility and reproductive performance of male and female rats at subcutaneous doses up to 10 mg/kg of body weight per day (32 times the recommended human dose based on body surface area) (Prod Info ARIXTRA subcutaneous injection, 2011).

Carcinogenicity

    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, the manufacturer does not report any carcinogenic potential for fondaparinux sodium in humans.
    3.21.4) ANIMAL STUDIES
    A) LACK OF INFORMATION
    1) At the time of this review, the manufacturer does not report any carcinogenic potential for fondaparinux sodium in animals (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Genotoxicity

    A) There was no evidence of genotoxicity in the following tests: Ames test, mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, human lymphocyte chromosome aberration test, rat hepatocyte unscheduled DNA synthesis (UDS) test, and rat micronucleus test (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor for evidence of bleeding (eg, venous access sites, urinary, gastrointestinal, vaginal).
    B) Monitor CBC with platelet count, vital signs, and hepatic enzymes in symptomatic patients.
    C) aPTT and INR are relatively insensitive in measuring the activity of fondaparinux at therapeutic doses, but may be prolonged after overdose.
    D) Plasma anti-factor Xa concentrations can be measured, but results are generally not available rapidly enough to use this to guide therapy.
    4.1.2) SERUM/BLOOD
    A) Routine coagulation monitoring is not required. However, monitor plasma anti-factor Xa in patients experiencing severe bleeding. Following fondaparinux doses of 2.5 mg daily and 7.5 mg daily, anti-Xa concentrations of 0.2 to 0.4 mcg/mL and 0.5 to 1.5 mcg/mL were achieved, respectively (Hirsh et al, 2008).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Monitor for evidence of bleeding (eg, venous access sites, urinary, gastrointestinal, vaginal).
    B) Monitor CBC with platelet count, vital signs, and hepatic enzymes in symptomatic patients.
    C) aPTT and INR are relatively insensitive in measuring the activity of fondaparinux at therapeutic doses, but may be prolonged after overdose.
    D) Plasma anti-factor Xa concentrations can be measured, but results are generally not available rapidly enough to use this to guide therapy.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Decontamination is not indicated; fondaparinux is only available parenterally.
    6.5.3) TREATMENT
    A) SUPPORT
    1) Oral exposure is unlikely, see the parenteral exposure section for further information.

Enhanced Elimination

    A) LACK OF EFFICACY
    1) Hemodialysis and hemoperfusion are UNLIKELY to be of value because of the high degree of protein binding and large volume of distribution; and the anticoagulation necessary to perform these techniques would likely increase bleeding.
    2) Clearance of fondaparinux was increased by 20% in patients undergoing chronic intermittent hemodialysis (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Range Of Toxicity

Summary

    A) TOXICITY: A minimum toxic dose has not been established.
    B) THERAPEUTIC DOSES: ADULTS: DVT PROPHYLAXIS, POSTOPERATIVE: 2.5 mg subQ once daily 6 to 8 hours after surgery and continued for 5 to 9 days; continue up to 24 additional days for extended prophylaxis in hip surgery. DVT/PULMONARY EMBOLISM TREATMENT: 5 mg to 10 mg subQ once daily for 5 to 9 days. CHILDREN: Safety and efficacy have not been established in pediatric patients.

Therapeutic Dose

    7.2.1) ADULT
    A) DVT PROPHYLAXIS, POSTOPERATIVE: 2.5 mg subQ once daily 6 to 8 hours after surgery and continued for 5 to 9 days; continue up to 24 additional days for extended prophylaxis in hip surgery (Prod Info ARIXTRA(R) subcutaneous injection solution, 2014).
    B) DVT/PULMONARY EMBOLISM TREATMENT: 5 mg to 10 mg subQ once daily for 5 to 9 days (Prod Info ARIXTRA(R) subcutaneous injection solution, 2014).
    7.2.2) PEDIATRIC
    A) Safety and efficacy have not been established in pediatric patients (Prod Info ARIXTRA(R) subcutaneous injection solution, 2014).

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Fondaparinux sodium is an antithrombotic drug that selectively binds to antithrombin III (ATIII), thereby potentiating the innate neutralization of Factor Xa. Neutralization of Factor Xa disrupts the blood coagulation cascade, which inhibits thrombin formation and thrombus development. Fondaparinux has no known effect on platelet function, and does not inactivate thrombin; therefore, it does not affect bleeding time or fibrinolytic activity at the recommended dose (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Physicochemical

Physical Characteristics

    A) FONDAPARINUX SODIUM is a clear and colorless to slightly yellow liquid (Prod Info ARIXTRA(R) subcutaneous injection, 2010).

Ph

    A) 5 to 8 (Prod Info ARIXTRA(R) subcutaneous injection, 2010)

Molecular Weight

    A) 1728 (Prod Info ARIXTRA(R) subcutaneous injection, 2010)

References

General Bibliography

    1) Amiral J, Lormeau JC, Marfaing-Koka A, et al: Absence of cross-reactivity of SR90107A/ORG31540 pentasaccharide with antibodies to heparin-PF4 complexes developed in heparin-induced thrombocytopenia. Blood Coag Fibrinolysis 1997; 8:114-117.
    2) Anon: Sanofi prepares pentasaccharide NDA for Nov. following favorable Phase III. FDC Reports, The Pink Sheet; 62(37):15, 2000a.
    3) Anon: Treatment of proximal deep vein thrombosis with a novel synthetic compound (SR90107A/ORG31540) with pure anti-factor Xa activity. Circulation 2000; 102:2726-2731.
    4) Bijsterveld NR, Moons AH, Meijers JCM, et al: Rebound thrombin generation after heparin therapy in unstable angina: a randomized comparison between unfractionated and low-molecular-weight heparin.. J Am Coll Cardiol 2002; 39:811-817.
    5) Ciurzynski M, Jankowski K, Pietrzak B, et al: Use of fondaparinux in a pregnant woman with pulmonary embolism and heparin-induced thrombocytopenia. Med Sci Monit 2011; 17(5):CS56-CS59.
    6) Hirsh J, Bauer KA, Donati MB, et al: Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133(6 Suppl):141S-159S.
    7) Kleinman ME, Chameides L, Schexnayder SM, et al: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Part 14: pediatric advanced life support. Circulation 2010; 122(18 Suppl.3):S876-S908.
    8) Peberdy MA , Callaway CW , Neumar RW , et al: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care science. Part 9: post–cardiac arrest care. Circulation 2010; 122(18 Suppl 3):S768-S786.
    9) Product Information: ARIXTRA (R) subcutaneous injection, fondaparinux sodium subcutaneous injection. GlaxoSmithKline, Research Triangle Park, NC, 2008.
    10) Product Information: ARIXTRA subcutaneous injection, fondaparinux sodium subcutaneous injection. GlaxoSmithKline (per Manufacturer), Research Triangle Park, NC, 2011.
    11) Product Information: ARIXTRA(R) subcutaneous injection solution, fondaparinux sodium subcutaneous injection solution. Aspen Global, Inc. (per FDA), Westbury, NY, 2014.
    12) Product Information: ARIXTRA(R) subcutaneous injection, fondaparinux sodium subcutaneous injection. GlaxoSmithKline, Research Triangle Park, NC, 2010.
    13) Product Information: dopamine hcl, 5% dextrose IV injection, dopamine hcl, 5% dextrose IV injection. Hospira,Inc, Lake Forest, IL, 2004.
    14) Product Information: norepinephrine bitartrate injection, norepinephrine bitartrate injection. Sicor Pharmaceuticals,Inc, Irvine, CA, 2005.
    15) Rosenberg RD: Redesigning heparin (editorial). N Engl J Med 2001; 344(9):673-674.
    16) Turpie AGG, Gallus AS, Hoek JA, et al: A synthetic pentasaccharide for the prevention of deep-vein thrombosis after total hip replacement. N Engl J Med 2001; 344(9):619-625.
    17) Young G, Yonekawa KE, Nakagawa PA, et al: Recombinant activated factor VII effectively reverses the anticoagulant effects of heparin, enoxaparin, fondaparinux, argatroban, and bivalirudin ex vivo as measured using thromboelastography. Blood Coagul Fibrinolysis 2007; 18(6):547-553.