Arixtra Solution for Injection 7.5 mg/0.6 ml

INJECTION, SOLUTION

**Dosage and Administration** **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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **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** 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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Treatment should be continued until the risk of venous thromboembolism 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 Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **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 Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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** The first _ARIXTRA_ ™ administration should be given not earlier than 6 hours following surgical closure. The injection should not be given unless haemostasis has been established. - **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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients **undergoing surgery**, the timing of the first dose of _ARIXTRA_ ™ requires strict adherence ( _see Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **Renal impairment** _**Prevention and treatment of VTE**_ In patients undergoing surgery, the timing of the first dose of _ARIXTRA_ ™ requires strict adherence. _ARIXTRA_ ™ should be used with caution in patients with moderate impairment (creatinine clearance 30–50 mL/min). _ARIXTRA_ ™ should not be used in patients with severe (creatinine clearance less than 30 mL/min) renal impairment ( _See Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**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 Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 ( _see Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients with severe hepatic impairment, _ARIXTRA_ ™ should be used with caution ( _see Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).