Arixtra

Arixtra Dosage/Direction for Use

fondaparinux sodium

Manufacturer:

Aspen

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
2.5 mg/0.5 mL: 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 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 after 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 Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
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 Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
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 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 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.
7.5 mg/0.6 mL: Adults: TREATMENT OF DVT AND PE: The recommended dose of ARIXTRA to be administered by subcutaneous injection once daily is: 5 mg for body weight less than 50 kg; 7.5 mg for body weight 50 to 100 kg; 10 mg for body weight greater than 100 kg.
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3). Concomitant treatment with vitamin K antagonists should be initiated as soon as possible, usually within 72 hours. The usual duration of ARIXTRA treatment is 5 to 9 days (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Special Populations: Children: The safety and efficacy of ARIXTRA in patients under the age of 17 has not been established (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Elderly (from 75 years): ARIXTRA should be used with caution in elderly patients as renal function decreases with age (see Renal impairment under Precautions).
2.5 mg/0.5 mL: In patients undergoing surgery, the timing of the first dose of ARIXTRA requires strict adherence (see Precautions).
Patients with body weight less than 50 kg: Patients with body weight below 50 kg are at increased risk of bleeding (see Precautions).
2.5 mg/0.5 mL: In patients undergoing surgery, the timing of the first dose of ARIXTRA requires strict adherence (see Precautions).
Renal impairment: ARIXTRA should not be used in patients with a creatinine clearance less than 30 ml/min (See Precautions and Pharmacology: Pharmacokinetics under Actions). No dosage reduction is required for patients with a creatinine clearance greater than or equal to 30ml/min.
2.5 mg/0.5 mL: In patients undergoing surgery, the timing of the first dose of ARIXTRA requires strict adherence.
Treatment of UA/NSTEMI and STEMI: ARIXTRA is not recommended for use in patients with a creatinine clearance of less than 20 ml/min (see Precautions). No dosage reduction is required for patients with a creatinine clearance greater than or equal to 20 ml/min.
Hepatic impairment: No dosing adjustment of ARIXTRA is necessary in patients with mild to moderate hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). In patients with severe hepatic impairment, ARIXTRA should be used with caution (see Precautions).
METHOD OF ADMINISTRATION: Subcutaneous 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 under Cautions for Usage).
2.5 mg/0.5 mL: 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.
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