ARIXTRA PI PDF

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. The presence of active major bleeding, e. To minimize bleeding risk, fondaparinux injection should be administered according to the recommended dosage regimen for peri-operative prophylaxis see Dosage ; administration before 6 hours after surgery has been associated an increased risk of major bleeding. In addition, the bleeding risk for spinal or epidural hematomas, which may result in permanent or long-term paralysis, may be greater with postoperative use of indwelling epidural catheters, a history of traumatic or repeated epidural or spinal puncture, a history of spinal deformity, a history of spinal surgery, or concomitant use of other drugs affecting hemostasis, such as NSAIDs, platelet inhibitors, or other anticoagulants.

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All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using Arixtra against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist.

Arixtra is used to prevent blood clots forming in patients who are recovering from orthopaedic or abdominal surgery. Arixtra is also used to treat blood clots once they have formed. Arixtra contains the medication fondaparinux sodium, a synthetic compound which helps prevent blood clots forming in blood vessels. This type of blood clot, also called deep venous thrombosis, or DVT, can occur in patients who are confined to bed after hip or knee surgery.

Your doctor may have prescribed Arixtra for another reason. Ask your doctor if you have any questions about why Arixtra has been prescribed for you. Do not use Arixtra if you have an allergy to it or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction to Arixtra may include skin rash, itchiness, shortness of breath, or difficulty breathing. Arixtra is not recommended for use during pregnancy, unless you and your doctor or pharmacist have discussed the risks and benefits involved.

If you are not sure whether you should start using Arixtra, talk to your doctor or pharmacist. Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor or pharmacist will discuss the possible risks and benefits of using Arixtra during pregnancy. Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed. Your doctor or pharmacist will discuss the possible risks and benefits of using Arixtra during breast-feeding.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:. Tell your doctor or pharmacist if you are elderly or have a low body weight less than 50 kg as you may be at increased risk of bleeding if you are given Arixtra. It is recommended that your doctor monitor's your blood platelets at the beginning and end of your treatment with Arixtra. If you have not told your doctor or pharmacist about any of the above, tell them before you start using Arixtra.

Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while using Arixtra. The usual dose of Arixtra is 2.

Arixtra may be given for up to 31 days. Arixtra is given to you as a subcutaneous injection an injection just under the skin. Arixtra should not be given as an intramuscular injection an injection into the muscle. The injections can be given by a doctor or nurse, or you may be taught how to give the injections to yourself.

Instructions on how to use the Arixtra syringe are contained in the package insert in each Arixtra carton. Your doctor or pharmacist has information on how to recognise and treat an overdose. Ask your doctor or pharmacist if you have any concerns. Tell any other doctors, dentists, and pharmacists who are treating you that you are using Arixtra.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are using Arixtra. If you have epidural or spinal anaesthesia a pain killing injection around the spinal cord , tell your doctor or nurse immediately if you have back pain, numbness or weakness in the legs, or problems with bowel or bladder function. Do not give Arixtra to anyone else, even if they have the same condition as you.

Do not use Arixtra to treat any other complaints unless your doctor or pharmacist tells you to. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Arixtra. Arixtra helps most people at risk of blood clots following surgery, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you get any side effects, do not stop using Arixtra without first talking to your doctor or pharmacist. These may be signs of serious side effects. You may need urgent medical attention. Serious side effects are rare. Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Arixtra will normally be stored in the pharmacy or on the hospital ward. The injection should be kept at room temperature less than 25 degrees C. If your doctor or pharmacist tells you to stop using Arixtra or the injections have passed their expiry date, ask your pharmacist what to do with any that are left over. Fondaparinux sodium is a white to almost white powder which is highly soluble in water and in dilute alkali solution, but insoluble in ethanol.

Chemical structure. MW: CAS number. Each pre-filled automatic safety syringe contains 2. For the full list of excipients, see Section 6. Mechanism of action. Fondaparinux is a synthetic and specific inhibitor of activated factor X Xa with no animal sourced components. By binding selectively to ATIII, fondaparinux potentiates about times the innate neutralisation of factor Xa by antithrombin. Neutralisation of factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.

Fondaparinux does not inactivate thrombin activated factor II and has no effects on platelet aggregation. It does not cross-react with sera from patients with heparin-induced thrombocytopaenia.

At the recommended dose, it does not affect fibrinolytic activity or bleeding time. At equivalent anti-thrombotic doses, an experimental bleeding model in rats demonstrates that fondaparinux induces less bleeding than unfractionated heparin.

Clinical trials. Over 21, patients age 17 to years; bodyweight 30 to kg have been studied in controlled Phase II and III clinical studies of fondaparinux. Prevention of VTE. In a double blind dose-response clinical study of fondaparinux 0. This dose effect relationship was confirmed in a second dose-response study performed in patients undergoing knee replacement.

Based on these studies, a 2. The efficacy of fondaparinux 2. The trials included sufficient numbers of patients to demonstrate the superiority of fondaparinux versus enoxaparin. Enoxaparin was administered according to two different regimens, the 40 mg daily regimen approved in Australia and Europe and the 30 mg b.

A randomised, double-blind clinical trial compared the efficacy of a subcutaneous once daily injection of fondaparinux 2. The efficacy data are provided in Table A randomised double blind clinical trial involving patients examined the additional effect of extending prophylaxis for VTE from 7 days to days.

See Table Major bleeding, all at surgical sites, was observed in 8 patients 2. Permanent premature treatment cessation was observed in 2 of these patients in the Arixtra group and in 1 patient in the placebo group.

In each group, two of these major bleeding episodes 0. Death occurred in 5 randomised patients 1. The 2 excess deaths with placebo were due to PE. In two randomised, double-blind, controlled clinical trials, the efficacy of a subcutaneous once daily injection of fondaparinux 2. In a randomised, double-blind, clinical trial in patients undergoing abdominal surgery, fondaparinux 2. A total of patients were randomised and were treated. The difference in the rate of VTE observed between patients taking fondaparinux and those taking dalteparin 4.

Treatment of deep vein thrombosis. The primary efficacy endpoint was confirmed, symptomatic, recurrent VTE reported up to Day Treatment of pulmonary embolism. OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2. The mean treatment duration was 5.

The primary adjudicated endpoint was a composite of death, myocardial infarction MI and refractory ischaemia RI within 9 days of randomisation. Of the patients in the fondaparinux group, 5. By Day 30, the incidence of all cause mortality was significantly reduced from 3. The effects on the incidence of MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.

At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2. In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8. In this subgroup, the incidence of major bleeding on fondaparinux and enoxaparin at Day 9 was 2. In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.

All enrolled patients received fondaparinux 2.

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