Fondaparinux

Fondaparinux
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

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Black Box Warning

WARNING: SPINAL/EPIDURAL HEMATOMAS

See full prescribing information for complete Boxed Warning.

Spinal/Epidural Hematomas: Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

Use of indwelling epidural catheters
Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
A history of traumatic or repeated epidural or spinal puncture
A history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.

Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

Overview

Fondaparinux is a Factor Xa inhibitor that is FDA approved for the {{{indicationType}}} of Prophylaxis of deep vein thrombosis (DVT) and DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding complications and thrombocytopenia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Deep Vein Thrombosis Prophylaxis

Recommended dose: 2.5 mgadministered by subcutaneous injection once daily after hemostasis has been established.
Administer the initial dose no earlier than 6 to 8 hours after surgery.
Administration of Fondaparinux earlier than 6 hours after surgery increases the risk of major bleeding.
The usual duration of therapy is 5 to 9 days; up to 11 days of therapy was administered in clinical trials.

In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended.
In patients undergoing hip fracture surgery, a total of 32 days (peri-operative and extended prophylaxis) was administered in clinical trials.

Deep Vein Thrombosis Prophylaxis Following Abdominal Surgery

Recommended dose: 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established.
Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of fondaparinux earlier than 6 hours after surgery increases the risk of major bleeding.
The usual duration of administration is 5 to 9 days, and up to 10 days of Fondaparinux was administered in clinical trials.

Deep Vein Thrombosis and Pulmonary Embolism Treatment

Recommended dose: 5 mg (body weight <50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight >100 kg) by subcutaneous injection once daily
Initiate concomitant treatment with warfarin sodium as soon as possible, usually within 72 hours.
Continue treatment with Fondaparinux for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2 to 3).
The usual duration of administration of Fondaparinux is 5 to 9 days; up to 26 days of Fondaparinux injection was administered in clinical trials.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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Contraindications

Severe renal impairment (creatinine clearance (CrCl) < 30 mL/min).
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).
History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to fondaparinux.

Warnings

WARNING: SPINAL/EPIDURAL HEMATOMAS

See full prescribing information for complete Boxed Warning.

Spinal/Epidural Hematomas: Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

Use of indwelling epidural catheters
Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
A history of traumatic or repeated epidural or spinal puncture
A history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.

Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

Hemorrhage

Use fondaparinux with extreme caution in conditions with increased risk of hemorrhage, such as congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, uncontrolled arterial hypertension, diabetic retinopathy, or shortly after brain, spinal, or ophthalmological surgery. Isolated cases of elevated aPTT temporally associated with bleeding events have been reported following administration of fondaparinux (with or without concomitant administration of other anticoagulants).

Do not administer agents that enhance the risk of hemorrhage with fondaparinux unless essential for the management of the underlying condition, such as vitamin K antagonists for the treatment of VTE. If co-administration is essential, closely monitor patients for signs and symptoms of bleeding.

Do not administer the initial dose of fondaparinux earlier than 6 to 8 hours after surgery. Administration earlier than 6 hours after surgery increases risk of major bleeding.

Renal Impairment and Bleeding Risk

Fondaparinux increases the risk of bleeding in patients with impaired renal function due to reduced clearance.

The incidence of major bleeding by renal function status reported in clinical trials of patients receiving fondaparinux for VTE surgical prophylaxis is provided in Table 1. In these patient populations, the following is recommended:

Do not use fondaparinux for VTE prophylaxis and treatment in patients with CrCl <30 mL/min
Use fondaparinux with caution in patients with CrCl 30 to 50 mL/min.

Assess renal function periodically in patients receiving fondaparinux. Discontinue the drug immediately in patients who develop severe renal impairment while on therapy. After discontinuation of fondaparinux, its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). The anticoagulant effects of fondaparinux may persist even longer in patients with renal impairment.

Bleeding Risk When Body Weight < 50 Kg

Fndaparinux increases the risk for bleeding in patients who weigh less than 50 kg, compared to patients with higher weights.

In patients who weigh less than 50 kg

Do not administer fondaparinux as prophylactic therapy for patients undergoing hip fracture, hip replacement, or knee replacement surgery and abdominal surgery.
Use fondaparinux with caution in the treatment of PE and DVT.

During randomized clinical trials of VTE prophylaxis in the peri-operative period following hip fracture, hip replacement, or knee replacement surgery and abdominal surgery, major bleeding occurred at a higher rate among patients with a body weight <50 kg compared to those with a body weight >50 kg (5.4% versus 2.1% in patients undergoing hip fracture, hip replacement, or knee replacement surgery; 5.3% versus 3.3% in patients undergoing abdominal surgery).

Thrombocytopenia

Thrombocytopenia can occur with the administration of fondaparinux. Thrombocytopenia of any degree should be monitored closely. Discontinue fondaparinux if the platelet count falls below 100,000/mm3. Moderate thrombocytopenia(platelet counts between 100,000/mm3 and 50,000/mm3) occurred at a rate of 3.0% in patients given fondaparinux 2.5 mg in the peri-operative hip fracture, hip replacement, or knee replacement surgery and abdominal surgery clinical trials. Severe thrombocytopenia (platelet counts less than 50,000/mm3) occurred at a rate of 0.2% in patients given fondaparinux 2.5 mg in these clinical trials. During extended prophylaxis, no cases of moderate or severe thrombocytopenia were reported.

Moderate thrombocytopenia occurred at a rate of 0.5% in patients given the fondaparinux treatment regimen in the DVT and PE treatment clinical trials. Severe thrombocytopenia occurred at a rate of 0.04% in patients given the fondaparinux treatment regimen in the DVT and PE treatment clinical trials.

Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported with the use of fondaparinux in postmarketing experience. [See Adverse Reactions (6.5)].

Neuraxial Anesthesia and Post-operative Indwelling Epidural Catheter Use

Spinal hematomas 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. In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of fondaparinux by subcutaneous (SC) injection. Monitor patients undergoing these procedures for signs and symptoms of neurologic impairment. Consider the potential risks and benefits before neuraxial intervention in patients anticoagulated or who may be anticoagulated for thromboprophylaxis.