A total of 3237 patients received fondaparinux with a dose ranging from 1. It is also used to treat existing blood clots in the lungs or in the veins. Fondaparinux sodium is administered by subcutaneous injection. Fondaparinux is used to prevent deep vein thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. Fondaparinux eurmp adherence the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
For additional information, consult the prescribing information for protamine sulfate injection. Jan 01, 2019 patient labeling is provided as a tearoff leaflet at the end of this full prescribing information. Authorization to share personal information form pdf 97. Spinalepidural hematomas see full prescribing information for complete boxed warning. Role of factor xa inhibitors in cancerassociated thrombosis. Fondaparinux sodium fda prescribing information, side. Prescribing information arixtra fondaparinux sodium injection spinalepidural hematomas when neuraxial anesthesia epiduralspinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids or. Fondaparinux may be restarted at least 6 hours postoperatively provided haemostasis has been. Side effects of arixtra fondaparinux sodium, warnings, uses. Fondaparinux medicare coverage see my plans prices. Arixtra fondaparinux sodium injection, usp is available in the following strengths. This medicine is used for several days after hip fracture surgery, hip or knee replacement surgery, and in some cases.
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins lmwh, heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. Call your doctor for medical advice about side effects. Our arixtra side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Prescription of fondaparinux in hospitalised patients. Fondaparinux by injection national library of medicine. Mylan institutional llc arixtra fondaparinux sodium. The only study with control group was the rct subgroup analysis, which compared fondaparinux to enoxaparin. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the site use agreement for health plans associated with envolve pharmacy solutions. Mylan manufactures arixtra fondaparinux sodium injection, solution arixtra in strengths of 25 mg05 ml 5 mgml5 mg04 ml 125 mgml75 mg06 ml 125 mgml10 mg08 ml 125 mgml. Pharmacy, employer quarterly, spring 2007, found at staticfilesequarterlyspring07. Fondaparinux sodium injection is intended for use under a physicians guidance. Fondaparinux is used after knee, hip, or abdominal surgeries to prevent blood clotting. Highlights of prescribing information these highlights do not include all the information needed to use arixtra safely and effectively. Policycriteria it is the policy of health plans affiliated with centene corporation that fondaparinux is medically necessary when the following criteria are met.
The approved prescribing information for fondaparinux in acs provides recommendations for use in patients. Successful use of fondaparinux early after mechanical. It is also known to not cause hit, as seen with ufh and lmwh. Pharmaceutical product pricing information for the medispan drug file. Arixtra fondaparinux sodium solution for subcutaneous injection initial u. Arixtra prescribing information version september 20. The test cannot distinguish between fondaparinux unfractionated and low molecular weight heparin. Hold fondaparinux at least 24 hours prior to surgery, or consider switch to ufh consult with surgeon. These highlights do not include all the information needed to use lovenox safely and effectively. Full prescribing information 1 indications and usage nourianz is indicated as adjunctive treatment to levodopacarbidopa in adult patients with parkinsons disease pd experiencing off episodes. The following conditions are contraindicated with this drug. These highlights do not include all the information needed to use kengreal safely and effectively. 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. Fondaparinux caused significantly more bleeding than enoxaparin after knee surgery.
Nejm comparison of fondaparinux and enoxaparin in acute coronary syndromes pdf. Full prescribing information pi nourianz istradefylline. Rx watchdog report trends in manufacturer prices of. Fondaparinux is a pentasaccharide synthetic derivative of unfractionated heparin ufh and lowmolecularweight heparin lmwh. Arixtra fondaparinux sodium is a sterile solution containing fondaparinux sodium. Oct 15, 2011 in this paper, we examine the role of injectable factor xa inhibitors in cancer patients, focusing on fondaparinux, the only such agent yet approved by the us food and drug administration fda. Fondaparinux arixtra is an anticoagulant that shares the same pentasaccharide sequence as ufh and lmwh for the binding to antithrombin, however it has no extra chain and thus, is not considered a heparin product. Emergent reversal of anticoagulation in the ed and icu settings. Fondaparinux is an antithrombotic agent with unique properties that may offer benefit to patients beyond the current approved indications. Particular caution is needed if fondaparinux is given to patients who have had spinal or epidural anaesthesia. Pricing, sizing, legal catgories and other medicinal forms information for fondaparinux sodium. Patients who do not receive thromboprophylaxis after an orthopedic surgery procedure will likely develop a.
North carolina state health plan for teachers and state employees. You will probably begin using fondaparinux injection while you are in the hospital at least 6 to 8 hours after your surgery. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. No dosage reduction is required for patients with mild renal impairment creatinine. Fondaparinux has a longer halflife than heparin and does not interact with platelets, both of which may be advantageous in certain settings. These highlights do not include all the information needed to use arixtra safely and effectively. Full prescribing information 1 indications and usage zilretta triamcinolone acetonide extendedrelease injectable suspension is indicated as an intraarticular injection for the management of osteoarthritis pain of the knee. Discounts annual analysis of members whose prescription claims. Because fatal reactions often resembling anaphylaxis have been reported with protamine, it should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. Fondaparinux is administered once daily, and its halflife is 17 hours. Since fondaparinux sodium does not bind significantly to plasma proteins other than. See full prescribing information for complete boxed warning.
Fondaparinux monitoring in a patient with heparininduced thrombocytopenia on hemodialysis or patients on chronic dialysis, a specific fondaparinux anticoagulation assay must be developed. Obtain baseline labs ptaptt hct platelet count scr serum creatinine 2. A drug list, or formulary, is a list of prescription drugs covered by your plan. Arixtra fondaparinux sodium injection usp qualitative and. Arixtra is supplied as a sterile, preservativefree injectable solution for subcutaneous use. Fondaparinux binds antithrombin and accelerates its inhibition of factor xa apart from the omethyl group at the reducing end of the molecule, the identity and sequence of the five monomeric sugar units contained in fondaparinux is identical to a sequence of five monomeric sugar units that can be isolated after either chemical. The paper covers clinical pharmacology, clinical pharmacokinetics, and available data from clinical trials in cancer patients. It is the policy of health plans affiliated with centene corporation that arixtra is. If the creatinine result is unavailable before the. It is usually given one time a day for 5 to 9 days or sometimes for up to about 1 month. Fondaparinux medicare coverage and copay details goodrx.
This is why doctors often prescribe a lowdose aspirin regimen to people with a history of cardiovascular disease. Each prefilled automatic safety syringe contains mg of fondaparinux 72 hours after the first study drug administration and continued for 90 7 days, with regular. Use of fondaparinux arixtra in acute coronary syndrome. Arixtra fondaparinux sodium solution for injection 2,5 mg 0,5 ml summary of product. Fondaparinux injection arixtra side effects, medical. See full prescribing information for fondaparinux sodium injection. Fondaparinux sodium injection is provided in a singledose, prefilled syringe affixed with an active needle protection system. Fondaparinux sodium does not inactivate thrombin activated factor ii and has no known effect on platelet function. Description the intent of the criteria is to ensure that patients follow selection elements established by centene clinical policy for fondaparinux arixtra. Arixtra fondaparinux is used to prevent a type of blood clot called deep vein thrombosis dvt, which can lead to blood clots in the lungs pulmonary embolism. Arixtra prescribing information version 92020, glaxosmithkline, research triangle park nc and garcia, et al.
Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin. The effectiveness of plavix results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome p450 cyp system, principally. Sections or subsections omitted from the full prescribing information are not listed. Guidelines for use of fondaparinux anticoagulation services. In conclusion, fondaparinux may be used as an alternative anticoagulation during hemodialysis in patients who develop hit. Safety and efficacy of fondaparinux in renal impairment. Three studies investigated fondaparinux as a prophylactic agent, 2 as a treatment agent, and 1 study investigated both. Download leaflet view the patient leaflet in pdf format. Arixtra fondaparinux sodium dose, indications, adverse. To explore the offlabel use versus approved use of. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Medicare coverage and pricing details for fondaparinux.
Listing a study does not mean it has been evaluated by the u. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. Arixtra fondaparinux sodium injection prescribing information. Background for many years, unfractionated heparin ufh was the mainstay of anticoagulation therapy for treatment and prevention of thrombosis. Highlights of prescribing information these highlights do not include all the information needed to use thyrogen safely and effectively. Arixtra fda prescribing information, side effects and uses. Fondaparinux sodium injection for subcutaneous use initial u. The effectiveness of plavix results from its antiplatelet activity, which is dependent on its. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and.
Fondaparinux is fda approved for initial therapy of dvt and pe as a bridge to warfarin therapy. The following is a description of indications, dosing and monitoring recommendations, contraindications, and pregnancy information. A synthetic pentasaccharide for the prevention of deepvein thrombosis after total hip replacement. Special pages permanent link page information wikidata item cite this page. Fondaparinux arixtra is a synthetic factor xa inhibitorsolution for subcutaneous injection. Dosing information lmwh enoxaparin lovenox o dvt prophylaxis. The pharmacotherapy handbook is intended to be used as a tool to aid in the appropriate prescribing and administration of. The risk of these events is increased by the use of indwelling epidural catheters for. Fondaparinux injection comes as a solution liquid to be injected subcutaneously just under the skin in the lower stomach area.
Read more about the prescription drug fondaparinux injection. Emergent reversal of anticoagulation in the ed and icu settings shirley chen, do baptist medical center, jacksonville, fl march 2016. Check with your physician if you have any of the following. Limitation of use the efficacy and safety of repeat administration of zilretta have not been demonstrated. Fondaparinux sodium injection usp qualitative and quantitative composition each prefilled syringe contains 2. Heparin vs lmwhs vs fondaparinux whats the difference. Highlights of prescribing information these highlights do not include all the information needed to use orbactiv safely and effectively. This is not a complete list of side effects and others may occur. Read the patient information leaflet if available from your pharmacist before you start using fondaparinux and each time you get a refill. Patient labeling is provided as a tearoff leaflet at the end of this full prescribing information.
Fondaparinux monitoring in a patient with heparininduced. Either animalreproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animalreproduction studies have shown an adverse effect other than a decrease in fertility that was not confirmed in controlled studies in women in the 1 st trimester and there is no evidence of a risk in later trimesters. Kengreal cangrelor for injection, for intravenous use. Fondaparinux is eliminated primarily unchanged in the urine. Fondaparinux sodium injection solution, for subcutaneous. Full prescribing information 1 indications and usage zeposia is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Each singledose, prefilled syringe of arixtra, affixed with an automatic needle protection system, contains 2. Prescription drug plan information and forms aarp medicare plans. Low molecular weight heparins lmwh, fondaparinux arixtra page 2 of 5 additional information this procedure is specific to knee replacement surgery, hip replacement or hip fracture surgery, abdominal surgery, and treatment of hypercoagulable states. Arixtra fondaparinux sodium solution for injection 2,5 mg 0,5 ml.
Highlights of prescribing information active pathological. Arixtra fondaparinux sodium solution for injection 7,5 mg. Dailymed arixtra fondaparinux sodium injection, solution. Arixtra fondaparinux dosing, indications, interactions. Important reminder at the end of this policy for important regulatory and legal information. In addition, fondaparinux is often used offlabel to anticoagulate clinically stable vte patients with suspected or proven hit. Why is fondaparinux arixtra an alternative anticoagulant. Lovenox enoxaparin sodium injection, for subcutaneous and intravenous use initial u. Arixtra fondaparinux sodium injection, solution mylan institutional llchighlights of prescribing information these highlights do not include all the information needed to use arixtra safely and effectively. Subcutaneous route solution epidural or spinal hematomas, which may result in longterm or permanent paralysis, can occur in patients who are anticoagulated with low molecular weight heparins, heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. Highlights of prescribing information these highlights do not include all the information needed to use argatroban injection safely and effectively. Arixtra fondaparinux sodium injection, solution arixtra. These highlights do not include all the information needed to. The antithrombotic activity of fondaparinux sodium is the result of antithrombin iii atiiimediated selective inhibition of factor xa.
It is a synthetic and specific inhibitor of activated factor x xa. It possesses increased affinity to inhibit factor xa compared with ufh and lmwhs. Successful use of fondaparinux early after mechanical aortic valve replacement in a patient with a history of heparininduced thrombocytopenia. It must not be administered by intramuscular injection. Arixtra fondaparinux sodium injection, solution arixtra 25. Contains less than 1 mmol of sodium 23 mg per dose, and therefore is essentially sodium free. Learn more about medicare prescription drug plans and savings with goodrx. Arixtra fondaparinux sodium injection solution for subcutaneous injection. Newer agents with more predictable pharmacokinetic profiles such as the low molecular weight heparins lmwhs and fondaparinux.
At the recommended dose, fondaparinux sodium does not affect fibrinolytic activity or bleeding time. Consumer information about the medication fondaparinux injection arixtra, includes side effects, drug interactions, recommended dosages, and storage information. Turpie agg, gallus as, hoek ja, for the pentasaccharide investigators. This drug will likely be quite expensive and you may want to. Patients with suspected heparininduced thrombocytopenia hit are at high risk for thromboembolic events and require anticoagulant therapy. Arixtra fondaparinux sodium solution for injection 2,5 mg. Lowdose aspirin not advised for hearthealthy people aarp. Arixtra official prescribing information for healthcare professionals. Mylan manufactures arixtra fondaparinux sodium injection, solution arixtra in strengths of 25 mg05 ml 5 mgml5 category. Arixtra, innfondaparinux sodium european medicines agency. Fondaparinux is a synthetic pentasaccharide factor xa inhibitor. Feb 18, 2020 arixtra is supplied as a sterile, preservativefree injectable solution for subcutaneous use. See full prescribing information for argatroban injection.