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fondaparinux (Rx)Brand and Other Names:Arixtra

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled syringe

  • 2.5mg/0.5mL
  • 5mg/0.4mL
  • 7.5mg/0.6mL
  • 10mg/0.8mL
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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

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Interactions

Interaction Checker

fondaparinux and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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)

            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

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Unknown whether drug is excreted in milk; use with caution

            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.

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            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

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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