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| __NOTOC__
| | #REDIRECT [[Argatroban#Use in Specific Populations]] |
| {{Argatroban}}
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| {{CMG}}; {{AE}} {{JH}}
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| ==Use in Specific Populations==
| | [[Category: Cardiovascular Drugs]] |
| | | [[Category: Drug]] |
| ====8.1 Pregnancy====
| | [[Category: Anticoagulants]] |
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| Pregnancy Category B
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| There are no adequate and well-controlled studies of argatroban use in pregnant women. Developmental studies performed in rats with argatroban at intravenous doses p to 27 mg/kg/day (0.3 times the maximum recommended human dose, based on body surface area) and in rabbits at intravenous doses up to 10.8 mg/kg/day (0.2 times the maximum recommended human dose, based on body surface area) have revealed no evidence of impaired fertility or harm to the fetus. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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| ====8.3 Nursing Mothers====
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| It is not known whether argatroban is excreted in human milk. Argatroban is detected in rat milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from argatroban, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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| ====8.4 Pediatric Use====
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| The safety and effectiveness of argatroban, including the appropriate anticoagulation goals and duration of therapy, have not been established among pediatric patients. Argatroban was studied among 18 seriously ill pediatric patients who required an alternative to [[heparin]] anticoagulation. Most patients were diagnosed with HIT or suspected HIT. Age ranges of patients were less than 6 months, n = 8; six months to less than 8 years, n=6; 8 to 16 years, n=4. All patients had serious underlying conditions and were receiving multiple concomitant medications. Thirteen patients received argatroban solely as a continuous infusion (no bolus dose). Dosing was initiated in the majority of these 13 patients at 1 mcg/kg/min. Dosing was titrated as needed to achieve and maintain an [[aPTT]] of 1.5 to 3 times the baseline value. Most patients required multiple dose adjustments to maintain anticoagulation parameters within the desired range. During the 30-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]]. Another patient completed 14 days of argatroban treatment in the study, but experienced an [[intracranial hemorrhage]] while receiving argatroban following completion of the study treatment period.
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| When argatroban is used among seriously ill pediatric patients with HIT/HITTS who require an alternative to heparin and who have normal hepatic function, initiate a contiguous infusion of argatroban at a dose of 0.75 mcg/kg/min. Initiate the infusion at a dose of 0.2 mcg/kg/min among seriously ill pediatric patients with impaired hepatic function [see Clinical Pharmacology (12.3)]. Check the [[aPTT]] two hours after the initiation of the argatroban infusion and adjust the dose to achieve the target [[aPTT]]. These dose recommendations are based upon a goal of [[aPTT]] prolongation of 1.5 to 3 times the baseline value and avoidance of an [[aPTT]] greater than 100 seconds. Increments of 0.1 to 0.25 mcg/kg/min for pediatric patients with normal hepatic function and increments of 0.05mcg/kg/min or lower for pediatric patients with impaired hepatic function may be considered but dose selection must take into account multiple factors including the current argatroban dose, the current [[aPTT]], target [[aPTT]], and the clinical status of the patient. These dose recommendations are based upon a goal of [[aPTT]] prolongation of 1.5 to 3 times the baseline value and avoidance of an [[aPTT]] greater than 100 seconds.
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| ====8.5 Geriatric Use====
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| Of the total number of subjects (1340) in clinical studies of argatroban, 35% were 65 and over. In the clinical studies of adult patients with HIT (with or without [[thrombosis]]), the effectiveness of argatroban was not affected by age. No trends were observed across age groups for both [[aPTT]] and the ACT. The safety analysis did suggest that older patients tended to have an increased incidence of events compared to younger patients; however, older patients had increased underlying conditions, which may predispose them to events. The studies were not sized appropriately to detect differences in safety between age groups.
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| ====8.6 Hepatic Impairment====
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| Dose reduction and careful titration are required when administering argatroban to patients with hepatic impairment. Reversal of anticoagulant effect may be prolonged in this population [see Dosage and Administration (2.3), Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = }}</ref>
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| ==Reference==
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| {{reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]] | |
| [[Category:Hematology]] | |
| [[Category:Drugs]] | |