Drug Guide
Fondaparinux Sodium
Classification
Therapeutic: Anticoagulant, Hematologic
Pharmacological: Factor Xa inhibitor
FDA Approved Indications
- Deep vein thrombosis (DVT) prophylaxis following surgery
- Pulmonary embolism (PE) treatment
Mechanism of Action
Fondaparinux selectively inhibits activated factor Xa through antithrombin III, leading to decreased thrombin generation and preventing clot formation.
Dosage and Administration
Adult: Prophylaxis of DVT/PE: 2.5 mg subcutaneously once daily; Treatment of PE or DVT: 5 mg, 7.5 mg, or 10 mg subcutaneously once daily, depending on body weight and clinical scenario.
Pediatric: Not approved for pediatric use.
Geriatric: Adjust dose based on renal function; monitor renal function regularly.
Renal Impairment: Reduce dose or avoid in severe renal impairment (CrCl <30 mL/min).
Hepatic Impairment: No specific adjustment recommended.
Pharmacokinetics
Absorption: Rapid, complete absorption after subcutaneous injection.
Distribution: Volume of distribution approximately 7-11 liters.
Metabolism: Minimal metabolism; primarily eliminated unchanged by kidneys.
Excretion: Renal excretion (main route).
Half Life: Approximately 17-21 hours.
Contraindications
- Hypersensitivity to fondaparinux or any component.
- Active major bleeding.
- Severe renal impairment (CrCl <30 mL/min).
Precautions
- Use with caution in patients with renal impairment, bleeding disorders, or recent surgery. Monitor renal function and signs of bleeding.
Adverse Reactions - Common
- Bleeding (Common)
- Injection site reactions (pain, erythema) (Less common)
Adverse Reactions - Serious
- Spontaneous bleeding (Rare)
- Thrombocytopenia (HIT) (Rare)
Drug-Drug Interactions
- Other anticoagulants, antiplatelet agents, NSAIDs increasing bleeding risk.
Drug-Food Interactions
- No significant food interactions reported.
Drug-Herb Interactions
- Potential additive bleeding risk with herbs affecting coagulation (e.g., ginkgo, garlic).
Nursing Implications
Assessment: Monitor signs of bleeding, check renal function before and during therapy, assess injection sites.
Diagnoses:
- Risk for bleeding
- Impaired tissue integrity related to hemorrhage.
Implementation: Administer subcutaneously as prescribed, ensure proper injection technique, monitor laboratory and clinical signs regularly.
Evaluation: Assess for signs of bleeding, monitor laboratory values (hemoglobin, hematocrit, platelet count).
Patient/Family Teaching
- Report any unusual bleeding, bruising, or pain.
- Use injectable medication as directed, do not aspirate or massage injection sites.
- Avoid activities that increase bleeding risk.
- Keep appointments for monitoring renal function.
Special Considerations
Black Box Warnings:
- Spinal/epidural hematomas risk with neuraxial anesthesia or lumbar puncture leading to paralysis.
Genetic Factors: None specific.
Lab Test Interference: Can cause false elevations in some assays of coagulation.
Overdose Management
Signs/Symptoms: Excessive bleeding, hemorrhage.
Treatment: Discontinue drug, apply pressure to bleeding sites, consider administration of andexanet alfa or recombinant activated factor VII in severe cases, supportive measures.
Storage and Handling
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F), protected from moisture.
Stability: Stable until the expiration date on the packaging.