ARGATROBAN PACKAGE INSERT PDF

Intracranial bleeding was not observed in subjects or patients who did not receive concomitant thrombolysis [see Drug Interactions 7. The safety and effectiveness of argatroban for cardiac indications other than PCI in patients with HIT have not been established. Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of acute stroke within 12 hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of patients 4. Asymptomatic intracranial hemorrhage occurred in 5 4.

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Intracranial bleeding was not observed in subjects or patients who did not receive concomitant thrombolysis [see Drug Interactions 7. The safety and effectiveness of argatroban for cardiac indications other than PCI in patients with HIT have not been established. Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of acute stroke within 12 hours of study entry.

Symptomatic intracranial hemorrhage was reported in 5 of patients 4. Asymptomatic intracranial hemorrhage occurred in 5 4. Allergic Reactions One hundred fifty-six allergic reactions or suspected allergic reactions were observed in 1, individuals who were treated with argatroban in clinical pharmacology studies or for various clinical indications.

Plasma from 12 healthy volunteers treated with argatroban over 6 days showed no evidence of neutralizing antibodies. No loss of anticoagulant activity was noted with repeated administration of argatroban to more than 40 patients. However, the concomitant use of argatroban and warfarin 5 to 7. There are risks to the mother associated with untreated thrombosis in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants see Clinical Considerations.

In animal reproduction studies, there was no evidence of adverse developmental outcomes with intravenous administration of argatroban during organogenesis in rats and rabbits at doses up to 0.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy.

Monitor neonates for bleeding [see Warnings and Precautions 5. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding.

Pregnant women receiving argatroban should be carefully monitored for evidence of excessive bleeding or unexpected changes in coagulation parameters [see Warnings and Precautions 5.

Argatroban is detected in rat milk. Argatroban was studied among 18 seriously ill pediatric patients who required an alternative to heparin anticoagulation. All patients had serious underlying conditions and were receiving multiple concomitant medications. Thirteen patients received argatroban solely as a continuous infusion no bolus dose. Most patients required multiple dose adjustments to maintain anticoagulation parameters within the desired range.

During the day study period, thrombotic events occurred during argatroban administration to two patients and following argatroban discontinuation in three other patients. Major bleeding occurred among two patients: one patient experienced an intracranial hemorrhage after 4 days of argatroban therapy in the setting of sepsis and thrombocytopenia and another patient experienced an intracranial hemorrhage after receiving argatroban for greater than 14 days.

Argatroban clearance in these seriously ill pediatric patients 0. Additionally, based on an evaluation of aPTT every two hours, increasing the dosage by 0. The safety and effectiveness of argatroban with the above dosing have not been adequately assessed in pediatric patients and the safety and effectiveness of argatroban is not established in pediatric patients.

In addition, the described dosage did not take into account multiple factors that could affect the dosage such as current aPTT, target aPTT, and the clinical status of the patient.

In the clinical studies of adult patients with HIT with or without thrombosis , the effectiveness of argatroban was not affected by age.

The safety analysis did suggest that older patients tended to have an increased risk of events compared to younger patients; however, older patients had increased underlying conditions, which may predispose them to adverse reactions.

The studies were not sized appropriately to detect differences in safety between age groups. Reversal of anticoagulation effect may be prolonged in this population [see Dosage and Administration 2. In clinical studies, anticoagulation parameters generally returned from therapeutic levels to baseline within 2 to 4 hours after discontinuation of the drug.

Reversal of anticoagulant effect may take longer in patients with hepatic impairment. No specific antidote to argatroban is available; if life-threatening bleeding occurs and excessive plasma levels of argatroban are suspected, discontinue argatroban immediately and measure aPTT and other coagulation parameters. The symptoms of acute toxicity were loss of righting reflex, tremors, clonic convulsions, paralysis of hind limbs, and coma. Argatroban has 4 asymmetric carbons. Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately Its molecular weight is The structural formula is: Argatroban Injection is a sterile, non-pyrogenic, clear, colorless to pale yellow isotonic solution.

It is supplied in a single-dose clear glass vial containing mg of argatroban in mL sodium chloride solution. The pH of the solution is between 3. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors V, VIII, and XIII; activation of protein C; and platelet aggregation.

Argatroban inhibits thrombin with an inhibition constant Ki of 0. At therapeutic concentrations, argatroban has little or no effect on related serine proteases trypsin, factor Xa, plasmin, and kallikrein.

Argatroban is capable of inhibiting the action of both free and clot-associated thrombin. Immediately upon initiation of argatroban infusion, anticoagulant effects are produced as plasma argatroban concentrations begin to rise. Steady-state levels of both drug and anticoagulant effect are typically attained within 1 to 3 hours and are maintained until the infusion is discontinued or the dosage adjusted.

Figure 1. However, concurrent therapy, compared to warfarin monotherapy, exerts no additional effect on vitamin K—dependent factor Xa activity. The relationship between INR on co-therapy and warfarin alone is dependent on both the dose of argatroban and the thromboplastin reagent used. Data for 2 commonly utilized thromboplastins with ISI values of 0. Thromboplastins with higher ISI values than shown result in higher INRs on combined therapy of warfarin and argatroban.

These data are based on results obtained in normal individuals [see Dosage and Administration 2. Figure 2.

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Argatroban

Intracranial bleeding was not observed in subjects or patients who did not receive concomitant thrombolysis [ see Drug Interactions 7. Intracranial bleeding was also observed in a prospective, placebo-controlled study of Argatroban in patients who had onset of acute stroke within 12 hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of patients 4. Asymptomatic intracranial hemorrhage occurred in 5 4.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

Taking argatroban during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant while taking argatroban. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Argatroban is not approved for use by anyone younger than 18 years old. How is argatroban given?

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