Dosing & Uses
Dosage Forms & Strengths
prefilled syringe
- 2.5mg/0.5mL
- 5mg/0.4mL
- 7.5mg/0.6mL
- 10mg/0.8mL
Deep Vein Thrombosis/Acute Pulmonary Embolism
Treatment
<50 kg: 5 mg SC once daily
50-100 kg: 7.5 mg SC once daily
>100 kg: 10 mg SC once daily
Administer for 5-9 days; up to 26 days administered in clinical trials
Prophylaxis
>50 kg: 2.5 mg SC once daily for 5-9 days or up to 10 days following abdomonal surgery; for hip replacement, 11 days recommended and a minimum 10-14 days recommended for patients undergoing total hip or knee arthroplasty, or hip fracture surgery; administered for up to 35 days in some instances
Heparin-Induced Thrombocytopenia (Off-label)
Prophylaxis of deep vein thrombosis (DVT) in patient with history of heparin-induced thrombocytopenia (HIT) until patient can switch to warfarin
2.5 mg SC once daily
American College of Chest Physicians (ACCP) guidelines assign low evidence rating to treatment of HIT with fondaparinux and conclude that further studies evaluating its role in HIT treatment are needed
Administration
Administer initial dose 6-8 hours after surgery, once hemostasis has been established
SC administration is deep, alternating right and left anterior and posterior abdominal walls
Safety and efficacy not established
Because bleeding is increased in adults <50 kg, bleeding may be a particular safety concern in children
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Anemia (1-20%)
Fever (4-14%)
Nausea (3-11%)
1-10%
Rash (7.5%)
Dizziness (4%)
Confusion (3%)
Constipation (5-9%)
Diarrhea (2-3%)
Edema (9%)
Headache (2-5%)
Hypokalemia (1-4%)
Hypotension (4%)
Insomnia (4-5%)
Purpura (4%)
Thrombocytopenia (3%)
Urinary retention (3%)
Urinary tract infection (2-4%)
Vomiting (1-6%)
Postmarketing Reports
Thrombocytopenia with thrombosis that manifested similarly to HIT
Serious allergic reactions, including angioedema and anaphylactoid or anaphylactic reactions
Spinal or epidural hematomas
Hemorrhage
Increase in bleeding risk with renal impairment
Increase in bleeding risk with body weight <50 Kg
Increase in aminotransferase levels
Warnings
Black Box Warnings
Epidural or spinal hematomas may occur in patients undergoing anticoagulation with low-molecular-weight heparins (LMWHs) or heparinoids who receive neuraxial (epidural or spinal) anesthesia or spinal puncture
These hematomas may result in long-term or permanent paralysis
Patients should be frequently monitored for signs and symptoms of neurologic impairment
If neurologic compromise is noted, urgent treatment is necessary
Physicians should weigh benefits against risk before embarking on neuraxial intervention in patients anticoagulated or scheduled to be anticoagulated for thromboprophylaxis
Optimal timing between the administration of LMWHs and neuraxial procedures is not known
Factors increasing risk of epidural or spinal hematomas
- Indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], platelet inhibitors, other anticoagulants)
- History of traumatic or repeated epidural or spinal punctures
- History of spinal deformity or spinal surgery
Contraindications
Severe renal impairment (CrCl <30 mL/min)
Body weight <50 kg (venous thromboembolism prophylaxis only)
Active major bleeding
Bacterial endocarditis
Thrombocytopenia with antiplatelet antibody in presence of fondaparinux
History of serious hypersensitivity reaction (eg, angioedema, anaphylactoid or anaphylactic reactions)
Cautions
Use with caution in the elderly (prolonged half-life in patients >75 years of age), peptic ulcer disease, bleeding disorder, recent stroke, recent surgery (brain, spinal cord, or eye), concurrent use of platelet inhibitors or anticoagulants, moderate renal impairment (CrCl 30-50 mL/min); may cause prolonged anticoagulation in patients with CrCl 30 to 50 mL/min
Discontinue if platelets <100,000/μL
Do not administer IM
Do not use interchangeably with heparin or LMWHs
Thrombocytopenia with thrombosis reported with use
Risk of spinal or epidural hematomas if spinal puncture occurs (see Black Box Warnings)
Increased risk of bleeding in patients <50 kg; dosage reduction recommended
Pregnancy & Lactation
Pregnancy
Available data from published literature and postmarketing reports have not reported clear association with adverse developmental outcomes; fondaparinux sodium plasma concentrations obtained from four women treated during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium; there are risks to mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants
Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy
Fetal/neonatal adverse reactions
- Drug has been demonstrated to cross placenta in humans; use of anticoagulants, may increase risk of bleeding in the fetus and neonate; monitor neonates for bleeding
Labor or delivery
- All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; pregnant women receiving therapy should be carefully monitored for evidence of bleeding or unexpected changes in coagulation parameters; consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches
Lactation
There are no data on presence in human milk, or effects on milk production; limited clinical data during lactation preclude a clear determination of risk of therapy to an infant during lactation; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Antithrombotic agent; inhibits factor Xa, which interrupts blood coagulation cascade and inhibits thrombin formaiton and thrombus development; generally does not increase prothrombin time (PT) or partial thromboplastin time (PTT)
Absorption
Bioavailability: 100%
Peak plasma time: 2-3 hr
Peak plasma concentration: 0.34-0.50 mg/L
Distribution
Protein bound: 94% (antithrombin III)
Vd: 7-11 L
Metabolism
Not established
Elimination
Half-life: 17-21 hr
Dialyzable: Yes
Excretion: Urine
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
