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

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

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Non–Guideline-Supported Use

Condition 1

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

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Condition 2

• Dosing Information

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Condition 2

• Developed by: (Organisation)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

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Non–Guideline-Supported Use

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Contraindications

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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

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

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Gastrointestinal

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Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

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Postmarketing Experience

(Description)

Drug Interactions

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Drug 1

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Drug 2

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Drug 3

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Drug 4

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Drug 5

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Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data. Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during Fondaparinux therapy. Observe these patients closely for signs and symptoms of bleeding.

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

• Fondaparinux injection is provided in a single-dose, prefilled syringe affixed with an automatic needle protection system.
• Fondaparinux is administered by subcutaneous injection. It must not be administered by intramuscular injection.
• Fondaparinux is intended for use under a physician’s guidance.
• Patients may self-inject only if their physician determines that it is appropriate and the patients are trained in subcutaneous injection techniques.
• Prior to administration, visually inspect fondaparinux to ensure the solution is clear and free of particulate matter.
• To avoid the loss of drug when using the prefilled syringe, do not expel the air bubble from the syringe before the injection.
• Administration should be made in the fatty tissue, alternating injection sites (e.g., between the left and right anterolateral or the left and right posterolateral abdominal wall).

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Fondaparinux
Systematic (IUPAC) name
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Chemical data
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Pharmacokinetic data
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Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

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Condition 3

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How Supplied

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Storage

There is limited information regarding Fondaparinux Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Fondaparinux interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fondaparinux Brand Names in the drug label.

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.