Argatroban package insert pdf

A clinicians test selection and interpretation, diagnosis, and patient management decisions should be based on hisher education, clinical expertise, and assessment of the. It is not a substitute for appropriate clinical evaluation and does not supersede clinical judgment. Turn the package over and insert the clear plastic spike through the diluent stopper by pressing straight down fig. Adult argatroban drip protocol this protocol reflects current evidence based clinical practice. Highdose argatroban for treatment of heparininduced. Highlights of prescribing information these highlights do. This is lower than heparin anticoagulation goals and approximately 2 x uhs normal range. In this article, we describe, to our knowledge, the largest prospective study of patients with hit reported to date. Pdf manufacturer recommendations for argatroban use in the setting of heparin induced.

Argatroban therapy in patients with atrial fibrillation and heparininduced. Thus, although argatroban undergoes hepatic metabolism, with a fourfold decrease in clearance and a threefold increase in elimination halflife eg, from approximately 51 to 181 minutes, package insert recommendations provide guidance on dose reductions eg, reducing the starting dose from 2. Aug 11, 2019 argatroban package insert pdf store in original package until time of use. Argatroban injection is supplied as a singledose vial containing 125 mg argatroban in 125 ml of aqueous sodium chloride solution 1 mgml. Argatroban is a formulary drug at our hospital, but obtaining it at some institutions could be challenging. We suggest that it should be available as a nonformulary alternative to lepirudin or bivalirudin if the physician emphasizes the need for a direct thrombin inhibitor not requiring renal adjustment in the setting of hit with renal. Remove the protective cap from the other end of the transfer.

Argatroban is the preferred parenteral anticoagulant for patients with a contraindication to ufh at the study site. This product information is intended only for residents of the united states. Full text update on argatroban for the prophylaxis and treatment of. Argatroban argatroban injection, solution this product information is intended only for residents of the united states. Child pugh classification for severity of liver disease. Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparininduced thrombocytopenia hit. Nov 01, 2018 argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65. Wait 3 hours after discontinuation of heparin infusion to start ar gatroban infusion.

The package insert states that the effectiveness of this device for this use has not been demonstrated. Argatroban injection should not be mixed with other drugs prior to dilution. Ddavp injection desmopressin acetate 4 mcgml has infrequently produced changes in blood pressure causing either a slight elev ation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. The vial is sealed with a gray rubber stopper and a green aluminum flipoff seal. The main attributes of this synthetic drug are its rapid onset of antithrombin. Highlights of prescribing information these highlights do not. The concomitant use of argatroban with warfarin results in prolongation of inr beyond that produced by warfarin alone. Adult argatroban drip protocol draft county of ventura. The use of antixa assay to monitor intravenous unfractionated. The metabolism of clopidogrel can also be impaired by drugs that inhibit cyp2c19, such.

Monitoring of argatroban and lepirudin sage journals. The use of argatroban for carotid endarterectomy in. Argatroban side effects, dosage, interactions drugs everyday health search. Argatroban is not for use in patients with moderate to severe hepatic insufficiency.

Highlights of prescribing information these highlights do not include all the information needed to use verzeniosafely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use angiomax safely and effectively. Argatroban suggested guidelines for use university of washington medical center dept of pharmacy for physician use only this is not intended as a nursemanaged protocol september 2008 background. The ki of argatroban for human thrombin is 40 nmoll, indicating lower affinity for thrombin than hirudin 22. Use only plastic syringes without anticoagulants or additives. Argatroban is a direct thrombin inhibitor that reversibly binds to the thrombin active site. Insert test strip as far as you can into the meter. Stop all heparin including catheter flushes, enoxaparin or dalteparin, and warfarin obtain baselines labs if none in past 24 hours cbc, ptt, ptinr, basic metabolic profile, lfts. This leaflet is part iii of a threepart product monograph published.

Ndc 6808314102 one package containing two vials of argatroban injection each vial contains 125 mg of argatroban. Argatroban fda prescribing information, side effects and. Verzenioabemaciclib tablets, for oral use initial u. Healthcare professionals argatroban injection in % sodium chloride mg ml 1 mg1 ml. Pdf heparininduced thrombocytopenia hit is a rare but potentially severe.

Argatroban anticoagulation in patients with heparin. Check with your doctor or nurse immediately if any of the following side effects occur while taking argatroban. Argatroban suggested guidelines for use university of. For those with active clot or high risk for clotting, there must be a five day overlap of both drugs and 2. Argatroban is highly selective for thrombin with an inhibitory constant k. Based on steady state correlation studies, argatroban levels between 0. Target is based on the prescribing information for argatroban which recommends targeting a steady state aptt of 1. Guidelines for the use of argatroban in hit anticoagulation. At therapeutic concentrations, argatroban has little or no effect on related serine proteases trypsin, factor xa, plasmin, and kallikrein. Direct thrombin inhibitors are recommended in confirmed or suspected heparininduced thrombocytopenia. Argatroban package insert pdf store in original package until time of use.

Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. See full prescribing information for argatroban injection. False elevation of the international normalized ratio inr occurs with these agents making bridging to warfarin challenging. Argatroban does not require the cofactor antithrombin iii for antithrombotic activity. Argatroban, a synthetic direct thrombin inhibitor, is indicated for the treatment and. Apr 25, 2019 argatroban package insert pdf store in original package until time of use. The use of argatroban in patients with hit and hitts is associated with. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Undergoing percutaneous coronary intervention pci with provisional use of glycoprotein iibiiia inhibitor gpi. The following pages are intended for viewing by healthcare professionals residing in the uk only. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze protect from. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials. In a prospective study 17 of argatroban use in patients with hit argatroban 911, argatroban therapy significantly reduced the primary composite end point of death, amputation, or new thrombosis in patients with isolated hit. This faq is provided for informational purposes only and is not intended as medical advice.

Argatroban package insert pdf posted on february 18, 2019 by admin store in original package until time of use. Pdf update on argatroban for the prophylaxis and treatment of. The drug should be used with caution in patients with coronary. Argatroban therapy in patients with atrial fibrillation. Argatroban exerts its anticoagulant effects by inhibiting thrombincatalyzed or. Argatroban dosing requirements in extracorporeal life. Argatroban is capable of inhibiting the action of both free and clotassociated thrombin. Angiomax bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients. In general, with doses of argatroban up to 2 gkgmin, argatroban can be discontinued when the inr is 4. Argatroban injection must be diluted 100fold prior to infusion. Argatroban exerts its anticoagulant effects by inhibiting thrombincatalyzed or induced. The molecular formula of argatroban is c 23 h 36 n 6 o 5 sh 2 o.

Note that argatroban is a nonformulary drug at uw medicine. Remove the protective cap from one end of the transfer device and keeping the vial of swfi upright, insert the piercing pin vertically into the center of the stopper of the vial of swfi. Although not all of these side effects may occur, if they do occur they may need medical attention. Argatroban is a a small molecule, synthetic direct thrombin inhibitor. Highlights of prescribing information these highlights do not include all the information needed to use ubrelvy safely and effectively.

Argatroban is dosed by pharmacists in accordance to an institutional argatroban dosing guideline. Find patient medical information for argatroban intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Evaluation of bivalirudins effect on international. Argatroban is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Apr 04, 2019 argatroban injection is supplied as a singledose vial containing 125 mg argatroban in 125 ml of aqueous sodium chloride solution 1 mgml. Update on argatroban for the prophylaxis and treatment of. Pdf weightbased argatroban dosing nomogram for treatment of. Argatroban is a synthetic direct thrombin inhibitor derived from larginine. The coaguchek xs pt test uses only fresh capillary or nonanticoagulated venous whole blood.

Discard product if it contains particulate matter, is cloudy, or. The coaguchek xs pt test uses only fresh capillary or non. Coaguchek xs pro pt controls package insert and this entire insert. Argatroban in sodium chloride injection is a sterile, nonpyrogenic, clear, colorless to pale yellow, aqueous solution. Andexxa coagulation factor xa recombinant, inactivated.

Open the package containing the reconstitution spike. Argatroban is a small molecule dti that acts by reversibly binding to the catalytic thrombin active site, thus inhibiting activation of factors v, viii and xiii the coagulant factors, as well as preventing fibrin formation and platelet aggregation hursting et al. The argatroban package insert recommends an initial i. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze argatroban package insert pdf store in original package until time of use.

Clinical practice guideline cpg development template uw health. Inr should be measured daily while argatroban and warfarin are coadministered. We compared aptt, thrombin time tt, and prothrombin time pt to drug levels obtained by the ecarin chromogenic assay. Argatroban is a synthetic, smallmolecule dti derived from arginine 527 da. Argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65. Along with its needed effects, argatroban may cause some unwanted effects. Comparison of a predefined dose increment nomogram with a. Argatroban injection is indicated as an anticoagulant in adult patients with or at risk for hit undergoing percutaneous coronary intervention pci. For detailed prescription information, refer to the manufacturers package insert for each medication. Argatroban in sodium chloride injection is a sterile, nonpyrogenic, clear, colorless to pale yellow solution. His past medical history infodmation a cerebrovascular accident with no residual deficit, chronic atrial fibrillation for which he was taking coumadin, a duodenal ulcer, type ii diabetes, benign prostatic hypertrophy, and bilateral cataract and glaucoma surgery. Clinical monitoring of direct thrombin inhibitors using. Argatroban is used to treat or prevent blood clots in adults who have thrombocytopenia low levels of platelets in the. A premature discontinuation of pradaxa increases the risk of thrombotic events, and b spinalepidural hematoma 1 indications and usage 1.

Demographic subgroup information coagulation factor xa recombinant, inactivatedzhzo andexxa refer to section 1. Open the package containing the transfer device by peeling the paper label off the package. Nov 09, 2018 argatroban blocks the activity of certain clotting substances in the blood. The recommended rate for argatroban administration through a continuous infusion is 0. Jul 30, 2019 argatroban package insert pdf store in original package until time of use. It reversibly binds to the active site pocket of thrombin alone and thus is a univalent dti. Place the diluents vial on a flat and solid surface. Mcmaster university department of medicine division of. No concurrent epidural analgesia, spinal, or lumbar puncture while anticoagulated. Argatroban argatroban for injection product monograph. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Argatroban anticoagulation in patients with heparininduced. It focuses on antithrombotic medications by drug class ex.

The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in cyp2c19 see boxed warning. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone see drug interactions 7. Argatroban side effects, dosage, interactions drugs. Aug 19, 2019 argatroban package insert pdf store in original package until time of use. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. No anticoagulation within 24 hours of therapeutic tpa for ischemic stroke. Argatroban fda prescribing information, side effects and uses.

Connect the syringe plunger to the sterile 10 ml prefilled syringe by screwing the plunger into the rubber stopper. May 25, 2017 argatroban injection is supplied as a single use vial containing 125 mg argatroban in 125 ml of 0. Aug, 2014 thus, although argatroban undergoes hepatic metabolism, with a fourfold decrease in clearance and a threefold increase in elimination halflife eg, from approximately 51 to 181 minutes, package insert recommendations provide guidance on dose reductions eg, reducing the starting dose from 2. The argatroban package insert states that a plasma argatroban concentration of 0. On day 9, venous thrombosis was detected, and a filter was inserted into the. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic. Study 970034, a randomized, doubleblind, comparative multicenter trial, evaluated the safety of ambisome 3 and 5 mgkgday compared with amphotericin b lipid complex 5 mgkgday in the empirical treatment of 202 adult and 42 pediatric neutropenic patients. Highlights of prescribing information acute ischemic stroke. The vial is sealed with a gray rubber stopper and a red aluminum flipoff seal. Argatroban is a synthetic direct thrombin inhibitor derived from l arginine. Argatroban glaxosmithkine and lepirudin berlex laboratories are both direct thrombin inhibitors dtis approved for the treatment of patients with heparininduced thrombocytopenia. Ndc 07828512 one package containing two vials of argatroban injection each vial contains 125 mg of argatroban. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite.