Fondaparinux Sodium

Registered South African indications: 

• Deep vein thromboembolism
• Pulmonary embolism
• Prophylaxis for venous thromboembolism
• ST segment elevation myocardial infarction (STEMI) acute coronary syndrome
• Unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) acute coronary syndrome

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment defined by creatinine clearance <30ml/min
• Active clinically significant bleeding
• Acute bacterial endocarditis

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Hepatic impairment
• Elderly
• Intramuscular injection
• Haemodynamically unstable patients 
• Patients requiring thrombolysis, embolectomy or insertion of a vena cava filter
• Increased risk of haemorrhage
• Patients who have undergone recent surgery (< 3 days) 
• Body weight below 50kg
• History of heparin induced thrombocytopenia
• Latex allergy
• Patients with both high body weight (> 100kg) and low body weight (< 50kg)
• Spinal/epidural anaesthesia 

Forms avail. in SA and covered in this monograph: inj

Treatment of deep vein thrombosis and acute pulmonary embolism
- Except if haemodynamically unstable

< 50 kg

• SC: 5mg, dly; Treatment duration: 5-9 days and adequate oral anticoagulation achieved

Between 50-100kg

• SC: 7.5mg, dly; Treatment duration: 5-9 days and adequate oral anticoagulation achieved

> 100kg

• SC: 10mg, dly; Treatment duration: 5-9 days and adequate oral anticoagulation achieved

Prophylaxis for venous thromboembolism
- In patients undergoing major orthopaedic surgery of the lower limb
- In patients undergoing abdominal surgery

• SC: 2.5mg, dly; Treatment duration: 5-9 days

The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established

Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) acute coronary syndrome
Treatment of ST segment elevation myocardial infarction (STEMI) acute coronary syndrome

• SC: 2.5mg, dly; Treatment duration: 8 days or until hospital discharge

STEMI: Initial dose should be given IV and subsequent doses should be given SC

If a patient is to undergo percutaneous coronary intervention (PCI) while on Fondaparinux Sodium, unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the patient's potential risk of bleeding, including the time since the last dose

In patients who are to undergo coronary artery bypass graft (CABG) surgery, Fondaparinux Sodium should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively

Not established for use in children below 17 years

Pregnancy

• Caution
• No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary

Breastfeeding

• Caution; not recommended
• Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breastfeeding is not recommended during treatment with fondaparinux. Oral absorption by the child is, however, unlikely

Fertility

• There is no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility

Renal Impairment

• CrCl ≥30 ml/min: Caution; no dose adjustment recommended
• CrCl <30ml/min: Contraindicated

Hepatic Impairment

• Caution; no dose adjustment recommended
  Closely monitor for signs of bleeding
  Child-Pugh Class C: Use with care as this patient group has not been studied 

Elderly            

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain

Hepatobiliary Disorders

• Abnormal hepatic function
• Increased hepatic enzymes 

Endocrine and Metabolic Disorders

• Increased non-protein-nitrogen

Skin and Subcutaneous Tissue Disorders

• Erythematous rash
• Pruritis
• Injection site reaction
• Oedema

Immune, Blood and Lymphatic System Disorders

• Bleeding 
• Anaemia
• Thrombocytopaenia
• Thrombocythaemia
• Allergic reactions

• Desirudin
• Fibrinolytic agents
• Glycoprotein P IIb/IIIa receptor antagonists
• Heparin
• Heparinoids
• Low molecular weight heparin (LMWH)
• Antiplatelet agents
• Non-steroidal anti-inflammatory drugs

• Full blood count
• Renal function
• Occult blood in stools

Specific cases may require

• Neurological examination

To avoid the loss of medicinal product when using the pre-filled syringe, do not expel the air bubble from the syringe before the injection

Fondaparinux is a synthetic and specific inhibitor of activated Factor X (Xa). The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa. By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralisation of Factor Xa by antithrombin. Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development. Fondaparinux does not inactivate thrombin (activated Factor II) and at therapeutic doses has no significant effect on platelets. At the recommended dose, it does not affect fibrinolytic activity or bleeding time.

Injection (per 0.5ml) 2.5mg

• Arixtra pre-filled (Pharmacare) originator

Injection (per 0.4ml) 5mg

• Arixtra pre-filled (Pharmacare)
• Arixtra pre-filled (GSK) originator

Injection (per 0.6ml) 7.5mg

• Arixtra pre-filled (Pharmacare) originator

Injection (per 0.8ml) 10mg

• Arixtra pre-filled (Pharmacare) originator