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ARIXTRA

Fondaparinux

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

Sterile, preservative-free, clear and colourless, injectable solution with a pH between 5.0 and 8.0, in a single dose pre-filled syringe.

Each syringe contains 2.5 mg of fondaparinux sodium in 0.5 ml solution for injection.

 

PHARMACEUTICAL FORM

Injectable solution for subcutaneous and intravenous use.

 

CLINICAL PARTICULARS

Indications Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as:

  - hip fracture;

  - knee replacement surgery;

  - hip replacement surgery.

 

Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.

 

Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at risk of thromboembolic complications due to restricted mobility during acute illness.

 

Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom an urgent (<120 mins) invasive management (PCI) is not indicated (see sections Warnings and Precautions & Pharmacological Properties).

 

Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy (see sections Warnings and Precautions & Pharmacological Properties).

 

Dosage and Administration

Method of administration

The sites of subcutaneous injection should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall. 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. The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger. The skin fold should be held throughout the injection.

 

ARIXTRA is intended for use under a physician's guidance. Patients may self-inject only if their physician determines that it is appropriate, and with medical follow-up as necessary. Proper training in subcutaneous injection technique should be provided. Instruction for self-administration is included in the package leaflet (see Instructions for Use/Handling).

 

Intravenous administration (first dose in STEMI patients only)

Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag. 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. The intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered. If administered via a mini-bag, the infusion should be given over 1 to 2 minutes.

 

Adults

PREVENTION OF VTE

Orthopaedic and abdominal surgery: the recommended dose of ARIXTRA is 2.5 mg once daily, administered post-operatively by subcutaneous injection.

 

The timing of the first dose should be no earlier than 6 hours following surgical closure, and only after haemostasis has been established (see Warnings and Precautions).

 

Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days alter surgery. Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery. In these patients the use of prolonged prophylaxis with ARIXTRA should be considered for up to an additional 24 days (see Clinical Studies).

 

Medical patients at risk of thromboembolic complications: the recommended dose of ARIXTRA is 2.5 mg once daily administered by subcutaneous injection. A treatment duration of 6 to 14 days has been clinically studied in medical patients (see Clinical Studies).

 

TREATMENT OF UNSTABLE ANGINA/NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (UA/NSTEMI)

The recommended dose of ARIXTRA is 2.5 mg once daily, administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to 8 days or until hospital discharge.

 

If a patient is to undergo percutaneous coronary intervention (PCI) while on ARIXTRA , 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 of ARIXTRA (see Warnings and Precautions).

 

The timing of restarting subcutaneous ARIXTRA after sheath removal should be based on clinical judgment. In the UA/NSTEMI clinical trial treatment with ARIXTRA was restarted no earlier than 2 hours after sheath removal.

 

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

 

TREATMENT OF ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)

The recommended dose of ARIXTRA is 2.5 mg once daily. The first dose of ARIXTRA is administered intravenously and subsequent doses are administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to 8 days or until hospital discharge.

 

If a patient is to undergo non-primary percutaneous coronary intervention (PCI) while on ARIXTRA , 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 of ARIXTRA (see Warnings and Precautions).

 

The timing of restarting subcutaneous ARIXTRA after sheath removal should be based on clinical judgment. In the STEMI clinical trial treatment with ARIXTRA was restarted no earlier than 3 hours after sheath removal.

 

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

 

Special Populations

Children

The safety and efficacy of ARIXTRA in patients under the age of 17 has not been established.

 

Elderly (from 75 years)

ARIXTRA should be used with caution in elderly patients as renal function decreases with age (see Renal impairment, Warnings and Precautions). In patients undergoing surgery, the timing of the first dose of ARIXTRA requires strict adherence (see Warnings and Precautions).

 

Patients with body weight less than 50 kg

Patients with body weight below 50 kg are at increased risk of bleeding (see Warnings and Precautions). In patients undergoing surgery, the timing of the first dose of ARIXTRA requires strict adherence (see Warnings and Precautions).

 

Renal impairment

No dosage reduction is required for patients with mild or moderate renal impairment. In patients undergoing surgery, the timing of the first dose of ARIXTRA requires strict adherence. ARIXTRA should not be used in patients with severe (creatinine clearance less than 30 ml/min) renal impairment (See Warnings and Precautions).

 

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