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an anticoagulant that binds to the thrombin active site and inhibits various thrombin-catalyzed reactions; used in the prophylaxis and treatment of thrombocytopenia resulting from treatment with heparin, administered intravenously.



Pharmacologic class: L-arginine-derived thrombin inhibitor

Therapeutic class: Anticoagulant

Pregnancy risk category B


Binds rapidly to site of thrombi, neutralizing conversion of fibrinogen to fibrin, activation of coagulation factors, and platelet aggregation (processes required for thrombus formation)


Injection: 100 mg/ml in 2.5-ml vials

Indications and dosages

Treatment or prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia

Adults: 2 mcg/kg/minute as a continuous I.V. infusion, to a maximum dosage of 10 mcg/kg/minute. Adjust dosage as needed to maintain activated partial thromboplastin time (APTT) at 1.5 to 3 times initial baseline value (not to exceed 100 seconds).

Anticoagulation during percutaneous coronary intervention in patients who have or are at risk for heparin-induced thrombocytopenia

Adults: Start continuous I.V. infusion at 25 mcg/kg/minute and give loading dose of 350 mcg/kg by I.V. bolus over 3 to 5 minutes. Check activated clotting time (ACT) 5 to 10 minutes after bolus dose is given; adjust dosage until ACT is between 300 and 450 seconds. If ACT is below 300 seconds, give additional I.V. bolus dose of 150 mcg/kg; then increase infusion rate to 30 mcg/kg/minute, and check ACT after 5 to 10 minutes. If ACT exceeds 450 seconds, decrease infusion rate to 15 mcg/kg/minute, and check ACT after 5 to 10 minutes. Maintain adjusted infusion dosage once therapeutic ACT has been reached.

Dosage adjustment

• Hepatic impairment


• Hypersensitivity to drug
• Overt major bleeding


Use cautiously in:
• hepatic impairment or disease, intracranial bleeding
• pregnant or breastfeeding patients
• children younger than age 18.


• Stop all parenteral anticoagulants before starting argatroban.
• Dilute in normal saline solution, dextrose 5% in water, or lactated Ringer's solution to a concentration of 1 mg/ml.
• Inject contents of 2.5-ml vial into 250-ml bag of diluent.
• Protect solution from direct sunlight.

Adverse reactions

CNS: headache

CV: hypotension, unstable angina, atrial fibrillation, cardiac arrest, ventricular tachycardia, cerebrovascular disorders

GI: nausea, vomiting, diarrhea, abdominal pain, anorexia, GI bleeding

GU: urinary tract infection, minor GU tract bleeding and hematuria, renal dysfunction

Hematologic: groin bleeding, brachial bleeding, hypoprothrombinemia, thrombocytopenia, bleeding or hemorrhage

Respiratory: cough, dyspnea, pneumonia, hemoptysis

Skin: rash, bleeding at puncture site

Other: allergic reaction, pain, infection, fever, sepsis, anaphylaxis


Drug-drug.Oral anticoagulants: prolonged prothrombin time, increased International Normalized Ratio, increased risk of bleeding

Thrombolytics: increased risk of intracranial bleeding

Drug-diagnostic tests.Hematocrit, hemoglobin: decreased values

Patient monitoring

Monitor patient for signs and symptoms of anaphylaxis.

Evaluate patient for bleeding tendency and hemorrhage.
• Assess neurologic status and vital signs frequently.
• Monitor CBC and coagulation studies, especially partial thromboplastin time.

Check for signs and symptoms of serious arrhythmias and hypotension.

Patient teaching

Instruct patient to immediately report allergic reaction and unusual bleeding or bruising.
• Tell patient to avoid activities that can cause injury. Advise him to use a soft toothbrush and electric razor to avoid gum and skin injury.
• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Tell patient that he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


/ar·gat·ro·ban/ (ahr-gat´ro-ban″) an anticoagulant used in the prophylaxis and treatment of heparin-induced thrombocytopenia.


an anticoagulant that binds to the thrombin active site and inhibits various thrombin-catalyzed reactions. It is used in the prophylaxis and treatment of thrombocytopenia resulting from treatment with heparin; administered intravenously.


A recombinant, direct thrombin-inhibitor-type anticoagulant used to manage heparin-induced thrombocytopaenia (HIT), heparin-induced thrombocytopaenia and thrombosis syndrome (HITTS) and for patients with or at risk for HIT undergoing percutaneous coronary intervention. It may be used with thrombolytics (e.g., tPA and streptokinase) in managing acute MI.


Novastan® Hematology An anticoagulant used to treat Pts with heparin-induced thrombocytopenia–HIT, heparin-induced thrombocytopenia & thrombosis syndrome–HITTS, which may be used with thrombolytics–eg, tPA and streptokinase in managing acute MI
References in periodicals archive ?
Management also reported that SmithKline Beecham (SB), the partner for the manufacturing and marketing of NOVASTAN in the U.
Under the agreement with SmithKline Beecham (SB) in August 1997, SB has the rights to market and co-develop NOVASTAN in the United States and Canada as anticoagulant therapy in patients with heparin-induced thrombocytopenia (HIT).
Stout, President North America of SB, stated, "With the positive action of the approvable letter for NOVASTAN from FDA, NOVASTAN now has the opportunity of ultimately fulfilling an unmet need and providing benefits to patients requiring this life-saving drug.
Texas Biotechnology yesterday received an "approvable" letter from the Food and Drug Administration for its anticoagulant, Novastan.
In addition to the development of NOVASTAN, the Company has two compounds in Phase II development.
McWilliams, President and CEO of Texas Biotechnology, stated, "During the third quarter, we continued to work with the United States Food and Drug Administration (FDA) and our marketing partner, SmithKline Beecham plc toward the approval and marketing of NOVASTAN as a treatment of heparin induced thrombocytopenia syndrome.
NOVASTAN, TBC's lead product, has been developed in collaboration with SmithKline Beecham as an anticoagulant for use in patients with heparin- induced thrombocytopenia syndrome.
The changes in this amendment involved correcting the coding of patient endpoint data and dates on which they occurred, and involved 33 of 304 patients in the pivotal Phase III trial that, when corrected, improved one of the efficacy analyses for NOVASTAN.
Overall, the corrected analyses do not change the positive clinical interpretation of the efficacy endpoints and have no effect on the safety analysis of NOVASTAN.
McWilliams stated, "Our goals for NOVASTAN are clear as we await review from the FDA.
NOVASTAN has been developed by Texas Biotechnology (TBC) in collaboration with SmithKline Beecham (SB) as an anticoagulant for use in patients with heparin-induced thrombocytopenia (HIT) syndrome who in the opinion of their physician require anticoagulation.