Fondaparinux Sodium
Generic Name: fondaparinux sodium
Brand Names:
Fondaparinux Sodium
11 DESCRIPTION Fondaparinux Sodium Injection USP is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyra-nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt.
Overview
11 DESCRIPTION Fondaparinux Sodium Injection USP is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyra-nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt.
Uses
1 INDICATIONS AND USAGE Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. ( 1.1 ) Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin.
Dosage
2 DOSAGE AND ADMINISTRATION For subcutaneous use, do not mix with other injections or infusions. ( 2.1 ) Prophylaxis of deep vein thrombosis: fondaparinux sodium 2.5 mg subcutaneously once daily after hemostasis has been established. The initial dose should be given no earlier than 6 to 8 hours after surgery and continued for 5 to 9 days. For patients undergoing hip fracture surgery, extended prophylaxis up to 24 additional days is recommended. ( 2.2 , 2.3 ) Treatment of deep vein thrombosis and pulmonary embolism:fondaparinux sodium 5 mg (body wright 100 kg) subcutaneously once daily. Treatment should continue for at least 5 days until INR 2 to 3 achieved with warfarin sodium.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Spinal or epidural hematomas [see Warnings and Precautions ( 5.1 )] . Hemorrhage [see Warnings and Precautions ( 5.2 )] . Renal impairment and bleeding risk [see Warnings and Precautions ( 5.3 )] . Body weight <50 Kg and bleeding risk [see Warnings and Precautions ( 5.4 )] . Thrombocytopenia [see Warnings and Precautions ( 5.5 )] . The most clinically significant adverse reactions associated with the use of fondaparinux sodium are bleeding complications. ( 6.1 ) Mild local irritation (injection site bleeding, rash and pruritus) may occur following subcutaneous injection.
Interactions
7 DRUG INTERACTIONS In clinical studies performed with fondaparinux sodium, the concomitant use of oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of fondaparinux sodium. In addition, fondaparinux sodium neither influenced the pharmacodynamics of warfarin, acetylsalicylic acid, piroxicam, and digoxin, nor the pharmacokinetics of digoxin at steady state. Agents that may enhance the risk of hemorrhage should be discontinued prior to initiation of therapy with fondaparinux sodium unless these agents are essential. If co-administration is necessary, monitor patients closely for hemorrhage.
Warnings
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. 5 WARNINGS AND PRECAUTIONS Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur. ( 5.1 ) Patient taking fondaparinux sodium with risk factors for bleeding are at increased risk of hemorrhage. ( 5.2 ) Bleeding risk is increased in renal impairment and in patients with low 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). 5.5 Thrombocytopenia Thrombocytopenia can occur with the administration of fondaparinux sodium. Thrombocytopenia of any degree should be monitored closely. Discontinue fondaparinux sodium if the platelet count falls below 100,000/mm3. 4 CONTRAINDICATIONS Fondaparinux sodium injection is contraindicated in the following conditions:( 4 ) Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [See Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 ).] Active major bleeding. Bacterial endocarditis.
Pregnancy
8.1 Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with fondaparinux sodium and adverse development outcomes. Fondaparinux sodium plasma concentrations obtained from four women treated with fondaparinux sodium during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Fondaparinux Sodium Injection USP is available in the following strengths and package sizes: 2.5 mg fondaparinux sodium in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with blue plunger rod.
Frequently Asked Questions
What is Fondaparinux Sodium used for?▼
1 INDICATIONS AND USAGE Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. ( 1.1 ) Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin.
What are the side effects of Fondaparinux Sodium?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Spinal or epidural hematomas [see Warnings and Precautions ( 5.1 )] . Hemorrhage [see Warnings and Precautions ( 5.2 )] . Renal impairment and bleeding risk [see Warnings and Precautions ( 5.3 )] . Body weight <50 Kg and bleeding risk [see Warnings and Precautions ( 5.4 )] . Thrombocytopenia [see Warnings and Precautions ( 5.5 )] . The most clinically significant adverse reactions associated with the use of fondaparinux sodium are bleeding complications. ( 6.1 ) Mild local irritation (injection site bleeding, rash and pruritus) may occur following subcutaneous injection.
Can I take Fondaparinux Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with fondaparinux sodium and adverse development outcomes. Fondaparinux sodium plasma concentrations obtained from four women treated with fondaparinux sodium during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium (see Data) .
What are the important warnings for Fondaparinux Sodium?▼
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. 5 WARNINGS AND PRECAUTIONS Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur. ( 5.1 ) Patient taking fondaparinux sodium with risk factors for bleeding are at increased risk of hemorrhage. ( 5.2 ) Bleeding risk is increased in renal impairment and in patients with low 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). 5.5 Thrombocytopenia Thrombocytopenia can occur with the administration of fondaparinux sodium. Thrombocytopenia of any degree should be monitored closely. Discontinue fondaparinux sodium if the platelet count falls below 100,000/mm3. 4 CONTRAINDICATIONS Fondaparinux sodium injection is contraindicated in the following conditions:( 4 ) Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [See Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 ).] Active major bleeding. Bacterial endocarditis.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.