To evaluate the cumulative evidence regarding the efficacy and safety of using fondaparinux in renal impairment, manifested by preventing new or recurrent thrombosis and the incidence of bleeding, respectively. Fondaparinux arixtra manufacturer prescribing information. Important reminder at the end of this policy for important regulatory and legal information. Arixtra prescribing information version september 20. Initiate apixaban, dabigatran, edoxaban, or rivaroxaban when next fondaparinux dose is expected to be given. Highlights of prescribing information these highlights do not include all the information needed to use revlimid safely and effectively. Arixtra, innfondaparinux sodium european medicines agency. Fondaparinux sodium injection solution, for subcutaneous. Detailed information on this medicinal product is available on the website of the european medicines. The risk of these events is increased by the use of indwelling epidural catheters for. You can ask your doctor or pharmacist for information about arixtra that is written for healthcare professionals. See full prescribing information for complete boxed. Safety and efficacy of fondaparinux in renal impairment. 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.
Medical record abstractors at each site obtained information regarding the use of fondaparinux and adjunctive anticoagulants during pci. Sections or subsections omitted from the full prescribing information are not listed. This medicinal product contains less than 23 mg of sodium in each. Pdf although rare, heparininduced thrombocytopenia hit is one of the. Arixtra fondaparinux sodium injection solution for subcutaneous injection initial u. A total of 3237 patients received fondaparinux with a dose ranging from 1. Hold fondaparinux at least 24 hours prior to surgery, or consider switch to ufh consult with surgeon. Pdf safety and efficacy of fondaparinux in renal impairment. Fondaparinux sodium is methyl o2deoxy6osulfo2sulfoamino. Highlights of prescribing information these highlights do not include all the information needed to use gemzarsafely and effectively. Arixtra reference guide for safe and effective use from the american society of. Call your doctor for medical advice about side effects.
Fondaparinux sodium arixtra pbm drug monograph template. Kengreal cangrelor for injection, for intravenous use. Arixtra fondaparinux sodium injection usp qualitative and. An agent to reverse the antifactor xa activity of apixaban is available. Arixtra fondaparinux sodium injection, solution arixtra 25. To evaluate the cumulative evidence regarding the efficacy and safety of using fondaparinux in renal impairment, manifested by preventing new or recurrent thrombosis and the incidence of. Administer 21 consecutive days of oral aripiprazole in conjunction with the first aristada injection. Fondaparinux sodium fda prescribing information, side. 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. 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. Physician adherence to fondaparinux prescribing information regarding the administration of an adjunctive anticoagulant during pci was estimated using generalized estimating equations.
These highlights do not include all the information needed to use bevyxxa safely and effectively. The only study with control group was the rct subgroup analysis, which compared fondaparinux to enoxaparin. Highlights of prescribing information these highlights do not include all the information needed to use pradaxa safely and effectively. Fondaparinux for the treatment of acute coronary syndromes. Each singledose, prefilled syringe of arixtra, affixed with an automatic needle protection system, contains 2.
Verzenioabemaciclib tablets, for oral use initial u. 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. Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders e. Dec 01, 2019 you can ask your doctor or pharmacist for information about arixtra that is written for healthcare professionals. Antivitamin k also carries a risk of hemorrhage, especially in elderly patients, requiring rigorous prescription and surveillance. Heparin is a heterogenous group of straightchain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. Page 4 of 5 series presents recommendations for the prevention, diagnosis, and treatment of thrombosis, addressing a comprehensive list of clinical conditions, including medical, surgery, orthopedic surgery. Arixtra fondaparinux sodium injection, solution arixtra. The pharmacotherapy handbook is intended to be used as a tool to aid in the appropriate prescribing and administration of. 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.
Pdf fondaparinux is a synthetic pentasaccharide belonging to a new group of. 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. Turpie agg, gallus as, hoek ja, for the pentasaccharide investigators. If the creatinine result is unavailable before the. A synthetic pentasaccharide for the prevention of deepvein thrombosis after total hip replacement. Epidural or spinal hematomas may occur in patients who are. Fondaparinux warfarin overlap fondaparinux with warfarin for at least 5 days and until inr is in therapeutic range. Highlights of prescribing information these highlights do not include all the information needed to use arixtra safely and effectively. For additional information, consult the prescribing information for protamine sulfate injection. To evaluate the cumulative evidence regarding the efficacy and safety of using fondaparinux in renal impairment, manifested by preventing new or recurrent thrombosis and the incidence. Fondaparinux sodium injection usp qualitative and quantitative composition each prefilled syringe contains 2. Pdf is fondaparinux an effective alternative anticoagulant in. It explains how the committee for medicinal products for human use chmp assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of.
Administer 21 consecutive days of oral aripiprazole. 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. 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. Added bridge to or contraindication to warfarin for dvt and pe. Download leaflet view the patient leaflet in pdf format. 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. It is a synthetic and specific inhibitor of activated factor x xa. Arixtra fondaparinux sodium solution for subcutaneous injection. Impact of lesion complexity on periprocedural adverse events and the benefit of potent intravenous platelet adenosine diphosphate receptor inhibition after percutaneous coronary intervention.
Fondaparinux must not be administered intramuscularly haemorrhage. This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodiumfree. Fondaparinux for the treatment of acute coronary syndromes acs. It possesses increased affinity to inhibit factor xa compared with ufh and lmwhs. This information in this handbook is intended for use by and with experienced physicians and pharmacists. 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.
It is the policy of health plans affiliated with centene corporation that arixtra is. Fragmin dalteparin sodium injection for subcutaneous use only initial u. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose i. Arixtra fondaparinux sodium injection is a sterile solution containing fondaparinux sodium. Fondaparinux experience in the treatmentprophylaxis of hithitt. Fondaparinux is a pentasaccharide synthetic derivative of unfractionated heparin ufh and lowmolecularweight heparin lmwh. Spinalepidural hematoma see full prescribing information for complete boxed. These highlights do not include all the information needed to use lovenox safely and effectively. Revlimid lenalidomide capsules, for oral use initial u. Fondaparinux is a synthetic pentasaccharide factor xa inhibitor.
These highlights do not include all the information needed to use arixtra safely and effectively. These highlights do not include all the information needed to use kengreal safely and effectively. Added continuation criteria for vte in presence of cancer. Three studies investigated fondaparinux as a prophylactic agent, 2 as a treatment agent, and 1 study investigated both. Highlights of prescribing information these highlights do not include all the information needed to use verzeniosafely and effectively. Pradaxa dabigatran etexilate mesylate capsules, for oral use. Gemzar gemcitabinefor injection, for intravenous use initial u. Fondaparinux arixtra is a synthetic selective indirect inhibitor of activated. This is not a complete list of side effects and others may occur. Arixtra fondaparinux dosing, indications, interactions. 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. National pbm drug monograph fondaparinux sodium arixtra vha pharmacy benefits management strategic healthcare group and medical advisory panel.
Transition of anticoagulants 2016 van hellerslia, pharmd, bcps. Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. Embryofetal toxicity, hematologic toxicity, and venous and arterial. Spinalepidural hematomas see full prescribing information for complete boxed warning. Arixtra fondaparinux sodium solution for injection 2,5 mg 0. Fondaparinux package insert pdf the recommended dose of fondaparinux is mg once daily administered instruction for selfadministration is mentioned in. Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin. Our arixtra side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Arixtra fondaparinux sodium injection prescribing information. See full prescribing information for complete boxed warning. Feb 18, 2020 arixtra is supplied as a sterile, preservativefree injectable solution for subcutaneous use. Initiate parenteral anticoagulant as clinically needed irrespective of time of last fondaparinux dose. Lovenox enoxaparin sodium injection, for subcutaneous and intravenous use initial u. Patient labeling is provided as a tearoff leaflet at the end of this full prescribing information.
Side effects of arixtra fondaparinux sodium, warnings, uses. The test cannot distinguish between fondaparinux unfractionated and low molecular weight heparin. Highlights of prescribing information these highlights do not include all the information needed to use orbactiv safely and effectively. Arixtra prescribing information version 92020, glaxosmithkline, research triangle park nc and garcia, et al.
Arixtra fda prescribing information, side effects and uses. For more information about arixtra, contact mylan at 18774463679 18774inforx. Patients who do not receive thromboprophylaxis after an orthopedic surgery procedure will likely develop a deep venous thrombosis dvt. Jan 01, 2019 patient labeling is provided as a tearoff leaflet at the end of this full prescribing information. This document is a summary of the european public assessment report epar for arixtra. Arixtra fondaparinux sodium solution for subcutaneous injection initial u. Fragmin dalteparin sodium injection for subcutaneous.
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