Arixtra package insert pdf

See full prescribing information for complete boxed. Fondaparinux package insert pdf the recommended dose of fondaparinux is mg once daily administered instruction for selfadministration is mentioned in the package leaflet. Use arixtra fondaparinux as ordered by your doctor. Each singledose, prefilled syringe of arixtra, affixed with an automatic needle protection system, contains 2. Fondaparinux sodium injection is provided in a singledose, prefilled syringe affixed with an active needle protection system. Arixtra fondaparinux is an inhibitor of the blood clotting factor x and is used to prevent blood clots, often in people undergoing certain surgical procedures. Pi trade names and active ingredients containing arixtra. Administer the initial dose no earlier than 6 to 8 hours after surgery.

The usual duration of administration of arixtra is 5 to 9 days. Fondaparinux is also used together with warfarin coumadin, jantoven to treat dvt, including pulmonary embolism. The needle protection system of the arixtra prefilled syringes have been arixtra package insert pdf instruction for selfadministration is mentioned in the package leaflet. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Arixtra prescribing information pdf gsk has halted all shipments of arixtra starter kits containing the triad for important product information, log onto. The needle protection system of the arixtra prefilled syringes have been designed with a. There are conflicting recommendations about the use of fondaparinux in patients with moderate renal impairment crcl 3050 mlmin. Administer the initial dose 12 3 hours prior to surgery. This emedtv page lists important arixtra warnings and precautions, including potentially serious side effects and possible drug interactions.

Adverse effects data are obtained from package inserts. Arixtra fondaparinux sodium injection usp qualitative and. Before you are given it when you must not use it do not use clexane if you have an allergy to clexane, heparin or its. Arixtra pharmacokinetics absorption bioavailability. Andexxa coagulation factor xa recombinant, inactivatedzhzo is a recombinant modified human factor xa fxa protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to lifethreatening or uncontrolled bleeding. Arixtra fondaparinux sodium solution for injection 2,5 mg 0. Administration of arixtra earlier than 6 hours after surgery increases the risk of major bleeding. Arixtra should not be used in people who may be hypersensitive allergic to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis an infection of the heart or have severe kidney problems. May, 2019 arixtra prescribing information pdf posted on may, 2019 by admin gsk has halted all shipments of arixtra starter kits containing the triad for important product information, log onto arixtra mg ml solution for injection, prefilled syringe. Rebetol monotherapy is not effective for the treatment of chronic hepatitis c virus infection and should not be used alone for this indication see warnings and precautions 5. A dose of lovenox of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks. Angiomax is intended for use with aspirin 300325 mg daily and has been studied only in patients receiving concomitant aspirin.

Please read this leaflet carefully before you start using arixtra. Read all of this leaflet carefully before you start using. Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment. Keep using arixtra fondaparinux as you have been told by your doctor. Arixtra reference guide for safe and effective use from the american society of. Although not all of these side effects may occur, if they do occur they may need medical attention. Dec 01, 2019 arixtra injection is provided in a singledose, prefilled syringe affixed with an automatic needle protection system. Mar 03, 2019 do not use arixtra if you are pregnant or intend to become pregnant. Administer one intramuscular injection of aristada initio 675 mg in. What should i discuss with my healthcare provider before using fondaparinux arixtra.

Arixtra blocks the activity of certain clotting substances in the blood. Fondaparinux sodium injection is intended for use under a physicians guidance. Arixtra injection is provided in a singledose, prefilled syringe affixed with an automatic needle protection system. Arixtra fondaparinux is a safe option for use in patients who have experienced a rare, lifethreatening reaction to another anticoagulant, heparin. Mylan manufactures arixtra fondaparinux sodium injection, solution arixtra in strengths of 25 mg05 ml 5 mgml5 mg04 ml mgml75 mg06 ml injection of arixtra mg in young healthy subjects are provided in table 1 below. Arixtra fondaparinux sodium injection prescribing information.

Arixtra prescribing information pdf gsk has halted all shipments of arixtra starter kits containing the triad for important product information, log onto arixtra mg ml solution for. The package insert should be consulted in such cases to determine the recommended dose. Arixtra is used to prevent a type of blood clot called deep vein thrombosis, which can lead to blood clots in the lungs pulmonary embolism. Fondaparinux may also be used for purposes not listed in this medication guide. Therefore, treatment in many situations will largely be symptomatic and supportive, meaning that it will aim to handle and minimize the complications that occur. Fondaparinux arixtra is a chemically synthesized version of the active pentasaccharide subunit of heparin that. Side effects of arixtra fondaparinux sodium, warnings, uses. Proper training in subcutaneous injection technique should be provided. Check with your doctor immediately if any of the following side effects occur while taking fondaparinux.

Arixtra fondaparinux sodium injection usp qualitative. Arixtra warnings and precautions contact your healthcare provider right away if you are taking arixtra and experience symptoms such as easy bruising, vomiting of blood, or vision changes. Arixtra fda prescribing information, side effects and uses. Arixtra is supplied as a sterile, preservativefree injectable solution for subcutaneous use. What are the possible side effects of fondaparinux arixtra. Find patient medical information for arixtra subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Arixtra fondaparinux dosing, indications, interactions. Arixtra fondaparinux sodium side effects, images, uses. It must not be administered by intramuscular injection. Evaluate all patients for a bleeding disorder before starting lovenox treatment, unless treatment is urgently needed.

This medication may not be safe for people with certain medical conditions, such as a bleeding disorder, high blood pressure, or an aneurysm. The package insert recommends use with caution in this patient. Fondaparinux package insert pdf the recommended dose of fondaparinux is mg once daily administered instruction for selfadministration is mentioned in the package. Fondaparinux arixtra and lmwh are contraindicated in patients with active major bleeding as. Jun 30, 2019 fondaparinux package insert pdf the recommended dose of fondaparinux is mg once daily administered instruction for selfadministration is mentioned in the package leaflet. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for arixtra fondaparinux. You may not be able to use arixtra safely if you weigh less than 110 pounds or have severe kidney problems. Switching to and from various anticoagulants disclaimer guidelines are not meant to replace clinical judgment or professional standards of care. If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot. Naloxone hydrochloride naloxone hydrochloride this product information is intended only for residents of the united states. Medical patients during acute illness the recommended dose of lovenox is 40 mg once a day administered by subcutaneous injection for. Each single dose, prefilled syringe of arixtra, affixed with an automatic needle protection system, contains 2.

Prior to administration, visually inspect arixtra to ensure the solution is clear and free of particulate matter. Fondaparinux for dvt prevention in moderate renal impairment. Feb 18, 2020 arixtra is supplied as a sterile, preservativefree injectable solution for subcutaneous use. Successful use of fondaparinux as an alternative anticoagulant in a 2monthold infant letter pediatr blood cancer. Patients may selfinject only if their physician determines that it is appropriate, and with medical followup as necessary.

Treatment for an arixtra overdose unlike with most other anticoagulants, there is no readily available, affordable, and effective antidote for an overdose with arixtra. What is the most important information i should know about fondaparinux arixtra. Arixtra fondaparinux sodium solution for subcutaneous injection. The recommended dose of angiomax is an intravenous iv bolus dose of. Refer to the prescribing information of oral aripiprazole for the recommended dosage and administration of the oral formulation. Arixtra fondaparinux sodium injection is a sterile solution containing. Fondaparinux in an obese child with heparininduced. For detailed prescription information, refer to the manufacturers package insert for each medication. An agent to reverse the antifactor xa activity of apixaban is available. Anticoagulant effects may persist for 24 days following discontinuance of therapy in patients with normal renal function i. Clinical judgment must take into consideration all. The needle protection system of the arixtra prefilled syringes have been.

Ask your doctor if you have any questions about why clexane has been prescribed for you. This medicine is only available with a doctors prescription. Arixtra fondaparinux sodium dose, indications, adverse effects, interactions from since ginkgo produces clinicallysignificant antiplatelet effects, it should be used cautiously in patients drugs that inhibit platelet aggregation or pose a risk for bleeding, such as anticoagulants. Jan 23, 2012 arixtra injection is provided in a singledose, prefilled syringe affixed with an automatic needle protection system.

Fragmin dalteparin sodium injection for subcutaneous use. The anticoagulant effects of fondaparinux sodium injection prophylactic therapy may persist even longer in patients with renal insufficiency. There are two ways to initiate treatment with aristada. A premature discontinuation of pradaxa increases the risk of thrombotic events, and b spinalepidural hematoma 1 indications and usage 1.

For the full list of all side effects reported with arixtra, see the package leaflet. Administer 21 consecutive days of oral aripiprazole in conjunction with the first aristada injection. Fondaparinux sodium is administered by subcutaneous injection. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose i. Dosing recommendations for patients with a crcl 30 mlmin, the recommended dose of pr adaxa is 150 mg taken orally, twice daily, after 5.

Fondaparinux arixtra is a synthetic anticoagulant based on the pentasaccharide sequence that makes up the minimal antithrombin at binding region of. Aranesp package insert pdf throughout this section of the package insert, the aranesp study numbers in 2 openlabel studies, aranesp or epoetin alfa were administered for the. Dec 22, 2019 fondaparinux package insert pdf the recommended dose of fondaparinux is mg once daily administered instruction for selfadministration is mentioned in the package leaflet. Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. The recommended dose of angiomax is an intravenous iv bolus dose of 0.

Technoview arixtra calibrator set is a set of plasmaderived calibration samples with arixtra. Arixtra fondaparinux sodium injection, solution arixtra 25. Arixtra package insert pdf instruction for selfadministration is mentioned in the package leaflet. Along with its needed effects, fondaparinux the active ingredient contained in arixtra may cause some unwanted effects. Arixtra will normally be stored in the pharmacy or on the hospital ward. Nov 22, 2018 arixtra fondaparinux sodium solution for injection 2,5 mg 0,5 ml patient information leaflet pil by aspen. Instruction for selfadministration is included in the package leaflet see instructions for. Enoxaparin sodium injection usp is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. Dec 24, 2019 aranesp package insert pdf throughout this section of the package insert, the aranesp study numbers in 2 openlabel studies, aranesp or epoetin alfa were administered for the. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic. Arixtra fondaparinux sodium injection, solution arixtra.

Continue treatment with arixtra for at least 5 days and until a therapeutic oral anticoagulant effect is established inr 2 to 3. Arixtra mg once daily following hip fracture surgery, patients were. Instructions on how to use the arixtra syringe are contained in the package insert in each arixtra carton. Highlights of prescribing information these highlights do. Insert the full length of the syringe needle perpendicularly into the skin fold held. Arixtra should be used with extreme caution in people who have other medical conditions that cause an increased bleeding risk. Jun 28, 2019 fondaparinux package insert pdf the recommended dose of fondaparinux is mg once daily administered instruction for selfadministration is mentioned in the package leaflet. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Jan 17, 2020 fondaparinux sodium injection is available in the following strengths and package sizes. Patients may selfinject only if their physician determines that it is appropriate and the patients are trained in subcutaneous injection techniques.

After discontinuation of fondaparinux sodium injection prophylactic therapy, its anticoagulant effects may persist for 24 days in patients with normal renal function i. It is given as a shot into the fatty part of the skin. Arixtra, innfondaparinux sodium european medicines agency. Instruction for selfadministration is mentioned in the package leaflet. Naloxone hydrochloride naloxone hydrochloride pfizer. Apr 25, 2019 argatroban package insert pdf store in original package until time of use.