ARIXTRA SOLUTION FOR INJECTION 7.5 MG/0.6 ML [SIN13586P]

Product Info

ARIXTRA SOLUTION FOR INJECTION 7.5 MG/0.6 ML

[SIN13586P]

Indication

Indications

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

• hip fracture

• major knee surgery;

• hip replacement surgery.

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

Treatment of Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE) except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) acute coronary syndrome for the prevention of death, myocardial infarction and refractory ischaemia (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment of ST segment elevation myocardial infarction (STEMI) acute coronary syndrome for the prevention of death and myocardial re-infarction in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

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).

Contraindications

Contraindications

• Known hypersensitivity to ARIXTRA™ or any of the excipients.

• Active clinically significant bleeding.

• Acute bacterial endocarditis.

• Severe renal impairment defined by creatinine clearance < 30 ml/min.