Fondaparinux

Introduction: Fondaparinux is an anticoagulant medicine used in the treatment of deep vein thrombosis (clot in veins of leg) and pulmonary embolism (clot in artery of lungs). It helps to prevent formation of harmful blood clots in blood vessels.

How it works: Fondaparinux, a synthetic pentasaccharide, acts as a selective inhibitor of activated factor X. It works by binding selectively to ATIII, and potentiates the neutralisation of Factor Xa, which interrupts the blood coagulation cascade and inhibits thrombin formation and thrombus development.

Important Information: This medicine is administered under the supervision of a doctor. It may increase your risk of bleeding. Let your doctor know immediately if you see pinpoint rash or blood in your vomits, urine, or stool.

• Prophylaxis of deep vein thrombosis (DVT): in patients undergoing hip fracture surgery, hip replacement surgery, knee replacement surgery or abdominal surgery.
• Treatment of DVT or acute pulmonary embolism (PE): when administered in conjunction with warfarin.

Parenteral anti-coagulants

Factor Xa inhibitor

The antithrombotic activity of Fondaparinux is the result of selective inhibition of Factor Xa. By selectively binding to antithrombin III (ATIII), Fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development. Fondaparinux does not inactivate thrombin and has no known effect on platelet function.

Fondaparinux binds to antithrombin III to inhibit Factor Xa activity, thereby preventing thrombin formation and blood clotting.

Adult Dose (DVT/Pulmonary Embolism Treatment):

• <50 kg: 5 mg SC once daily
• 50-100 kg: 7.5 mg SC once daily
• >100 kg: 10 mg SC once daily
• Administer for 5-9 days (up to 26 days in clinical trials)

Prophylaxis:

• >50 kg: 2.5 mg SC once daily for 5-9 days or up to 10 days
• Hip replacement: 11 days recommended
• Knee or hip fracture: minimum 10-14 days recommended

Renal Impairment (CrCl):

• <20: Contraindicated
• 20-50: 1.5 mg once daily

Children: Safety and efficacy not established.

* Use as directed by the registered physician

Subcutaneous injection. Your doctor or nurse will give you this medicine. Do not self administer.

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

• Bleeding
• Anemia
• Injection site bleeding, rash and pruritus
• Insomnia
• Hypokalemia
• Dizziness
• Hypotension
• Confusion
• Hematoma
• Post-operative hemorrhage

Precautions:

• Increases risk of bleeding - be careful while shaving, cutting nails or using sharp objects.
• Bleeding risk is increased in renal impairment.
• Increased risk in patients with low body weight <50 kg.
• Thrombocytopenia can occur - regular platelet count monitoring recommended.
• Do not discontinue use without consulting your doctor.

Contraindications:

• Severe renal impairment (CrCl <30 mL/min)
• Active major bleeding
• Bacterial endocarditis
• Thrombocytopenia
• Body weight <50 kg (VTE prophylaxis only)
• History of serious hypersensitivity reaction to Fondaparinux

Drug Interactions:

• Increased risk of bleeding with other anticoagulants (desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids or LMWH).

Food Interactions:

• Unsafe to consume alcohol with Fondaparinux.

Use in Pregnancy: Generally considered safe during pregnancy. Animal studies have shown low or no adverse effects to the developing baby.

Use in Lactation: Probably safe during breastfeeding. Limited data suggests the drug does not represent any significant risk to the baby.

Pediatric Use: Safety and efficacy in pediatric patients have not been established.

Geriatric Use: In clinical trials, efficacy in the elderly (65+) was similar to younger patients; however, serious adverse events increased with age.

Renal Impairment: Use with caution in kidney disease. CrCl <20: Contraindicated. CrCl 20-50: 1.5 mg once daily.

Hepatic Impairment: Use with caution in severe liver disease.

Overdose: Overdose increases the risk of bleeding. No specific antidote. Give supportive care.

Storage: Store below 25°C. Do not freeze. Keep out of reach of children.

Fondaparinux Injection