FONDAPARINUX SODIUM

Manufacturer: Eugia US LLC

Score: 144.0

Quick Summary

Fondaparinux sodium is an anticoagulant used to prevent deep vein thrombosis (DVT) in patients undergoing hip fracture, hip replacement, or knee replacement surgery, as well as for the treatment of DVT and pulmonary embolism. It works by inhibiting Factor Xa, which plays a crucial role in blood coagulation. The recommended dose is 2.5 mg subcutaneously once daily for prophylaxis, and 5-10 mg subcutaneously once daily for treatment, depending on body weight. Fondaparinux sodium is contraindicated in patients with severe renal impairment, active major bleeding, and a history of serious hypersensitivity reactions. Special considerations are needed for patients with renal impairment, body weight less than 50 kg, and the elderly.

Key Clinical Findings and Indications

Prevention of deep vein thrombosis (DVT) in patients undergoing hip fracture, hip replacement, or knee replacement surgery
Treatment of DVT and pulmonary embolism
Inhibition of Factor Xa, which plays a crucial role in blood coagulation

Important Safety Information

Warning

Increased risk of bleeding, particularly in patients with renal impairment, body weight less than 50 kg, and the elderly

Contraindications

Severe renal impairment (creatinine clearance <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 prophylaxis only)
History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to fondaparinux sodium injection

Adverse Reactions

Bleeding complications
Hemorrhage
Anemia
Insomnia
Wound drainage increased
Hypokalemia
Dizziness
Purpura
Hypotension
Confusion
Bullous eruption
Hematoma
Post-operative hemorrhage

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal impairment or body weight less than 50 kg

Prophylaxis of deep vein thrombosis

Adult Dose

2.5 mg subcutaneously once daily

Pediatric Dose

Not established

Treatment of deep vein thrombosis and pulmonary embolism

Adult Dose

5-10 mg subcutaneously once daily, depending on body weight

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

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

Nursing Mothers

There are no data on the presence of fondaparinux sodium in human milk
Limited clinical data during lactation preclude a clear determination of the risk of fondaparinux sodium to an infant during lactation

Pediatric Use

Safety and effectiveness of fondaparinux sodium in pediatric patients have not been established
Bleeding may be a particular safety concern for use of fondaparinux sodium in the pediatric population

Geriatric Use

In clinical trials, the efficacy of fondaparinux sodium in the elderly (65 years or older) was similar to that seen in patients younger than 65 years
Serious adverse events increased with age
Fondaparinux sodium is substantially excreted by the kidney, and the risk of adverse reactions to fondaparinux sodium may be greater in patients with impaired renal function

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