Exarane/Exarane Forte

Prophylaxis of Venous Thrombosis

Prophylaxis against thromboembolism should be tailored according to the patient's risk. Risk factors include age over 40 years, history of deep vein thrombosis or pulmonary embolism, surgery and other trauma, prolonged immobilisation, cardiac disease, obesity, malignancy, varicose veins, hypercoagulable states, pregnancy and the puerperium, oral contraceptives, severe infection, inflammatory bowel disease.

a) High Risk Patients

In patients with high risk of thromboembolism, a Exarane dosage of 40 mg (0.4 mL; anti-Xa: 4000 IU) should be administered subcutaneously once daily. In high risk patients undergoing surgery, the initial dose should be given approximately 12 hours preoperatively. The timing of the first dose may need to be modified if spinal/epidural anaesthesia is to be performed.

b) Moderate Risk Patients

In patients with a moderate risk of thromboembolism, the recommended Exarane dosage is 20 mg (0.2 mL; anti‑Xa: 2000 IU) subcutaneously once daily. In moderate risk patients undergoing surgery, the initial dose should be given approximately 2 hours preoperatively. The timing of the first dose may need to be modified if spinal/epidural anaesthesia is to be performed.

Duration of Therapy

High to Moderate Risk: Prophylaxis should be continued for 7 to 10 days or until the risk of thromboembolism has diminished.

Prolonged Thromboprophylaxis

Therapy with 40 mg once daily for 30 post-operative days has been proven to be beneficial in total hip replacement surgery.

Under normal conditions of use, Exarane does not modify global clotting tests and therefore there is no need to perform these tests in order to monitor therapy.

Prophylaxis of Venous Thromboembolism in Medical Patients

The recommended dose should be 40 mg once daily by subcutaneous injection for a minimum of 6 days, continuing for a maximum of 14 days or less if the patient returns to full ambulation earlier than 14 days.

Treatment of Deep Venous Thrombosis

The initial clinical trials which established the efficacy of Exarane in the treatment of deep venous thrombosis were conducted on patients who were initially treated with heparin and then changed to Exarane when a definitive diagnosis was established. However, the use

of heparin prior to Exarane is not currently recommended. The average duration of therapy in the clinical trials was 10 days. No data are available on the safety of long term treatment. Data on use in patients over 65 years of age in these trials were limited.

The recommended dosage for treatment of established deep vein thrombosis with Exarane is 1.5 mg/kg body weight once daily (150 IU anti-Xa activity/kg bodyweight) or 1 mg/kg body weight (100 IU anti-Xa activity/kg bodyweight) twice daily subcutaneously. In high risk patients, for example, the obese or patients with baseline iliac vein thrombosis or cancer, a dose of 1 mg/kg body weight administered twice daily may be more beneficial.

Warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of commencing Exarane initiation). Exarane should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0).

Treatment of Unstable Angina and Non-Q-Wave Myocardial Infarction

The recommended dose of Exarane is 1 mg/kg every 12 hours by subcutaneous injection, administered concurrently with oral aspirin. Treatment with Exarane in these patients should be prescribed for a minimum of 2 days and a maximum of 8 days.

Treatment of Acute ST-segment Elevation Myocardial Infarction (STEMI)

In patients with acute ST-segment elevation myocardial infarction, administered in conjunction with a fibrinolytic (fibrin-specific or non-fibrin specific), the recommended dose of Exarane is a single intravenous bolus of 30 mg plus a 1 mg/kg subcutaneous dose, followed by 1 mg/kg administered subcutaneously every 12 hours (maximum 100 mg for each of the first two subcutaneous doses only, followed by 1 mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see Section 4.2 of the PI - Dose and method of administration: Use in Renal Impairment and Use in the Elderly.

When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Exarane should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive aspirin as soon as they are identified as having

STEMI (100 to 300 mg once daily, unless contraindicated). The recommended duration of Exarane treatment is 8 days or until hospital discharge, whichever comes first.

For patients further managed with Percutaneous Coronary Intervention (PCI): If the last Exarane subcutaneous administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Exarane subcutaneous administration was given more than 8 hours before balloon inflation, an intravenous bolus of 0.3 mg/kg of Exarane should be administered.

Haemodialysis

In patients undergoing repeated sessions of haemodialysis, the prevention of thrombosis in the extracorporeal blood circuit is obtained by injection of a dose of 1 mg/kg (100 IU anti-Xa activity/kg) into the arterial line of the dialysis circuit at the start of the session. This dose is usually sufficient for a 4-hour haemodialysis session. If fibrin rings are formed, a fresh injection of 0.5 to 1 mg/kg (50 to 100 IU anti-Xa activity/kg) should be made depending on the time before the end of the dialysis.

In haemodialysed patients with a high risk of haemorrhage, (in particular, in pre or postoperative dialysed patients) or with a progressive haemorrhagic disorder, the dialysis sessions may be carried out by using a dose of 0.5 mg/kg (50 IU anti-Xa activity/kg) (double vascular access) or 0.75 mg/kg (75 IU anti-Xa activity/kg) (single vascular access).             

For further information refer to the Product Information.