View source for Desirudin use in specific populations

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{{Desirudin}}
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==Use In Specific Populations==
===Renal Insufficiency=== 

In a pharmacokinetic study of renally impaired subjects, subjects with mild [creatinine clearance (CC) between 61 and 90 mL/min/1.73 m2 body surface area], moderate (CC between 31 and 60 mL/min/1.73 m2 body surface area), and severe (CC below 31 mL/min/1.73 m2 body surface area) renal insufficiency, were administered a single IV dose of 0.5, 0.25, or 0.125 mg/kg desirudin, respectively. This resulted in mean dose-normalized AUCeffect (AUC0-60th for aPTT prolongation) increases of approximately 3-, and 9-fold for the moderate and severe renally impaired subjects, respectively, compared with healthy individuals. In subjects with mild renal impairment, there was no increase in AUCeffect compared with healthy individuals. In subjects with severe renal insufficiency, terminal elimination half-lives were prolonged up to 12 hours compared with 2 to 4 hours in normal volunteers or subjects with mild to moderate renal insufficiency (see WARNINGS). Dose adjustments are recommended in certain circumstances in relation to the degree of impairment or degree of aPTT abnormality (see WARNINGS: Renal Insufficiency,PRECAUTIONS: Laboratory Tests, and DOSAGE AND ADMINISTRATION: Monitoring and Adjusting Therapy; Use in Renal Insufficiency).

===Hepatic Insufficiency===

No pharmacokinetic studies have been conducted to investigate the effects of Iprivask in hepatic insufficiency (see PRECAUTIONS, Hepatic Insufficiency/Liver Injury and DOSAGE and ADMINISTRATION).

===Age/Gender===

The mean plasma clearance of desirudin in patients ≥65 years of age (n=12; 110 mL/min) is approximately 28% lower than in patients <65 years of age (n=8; 153 mL/min). Population pharmacokinetics conducted in 301 patients undergoing elective total hip replacement indicate that age or gender do not affect the systemic clearance of desirudin when renal creatinine clearance is considered. This drug is substantially excreted by the kidney, and the risk of adverse events due to it may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Dosage adjustment in the case of moderate and severe renal impairment is necessary. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency, DOSAGE and ADMINISTRATION, Use in Renal Insufficiency).

===Pregnancy===

Teratogenic Effects: Pregnancy Category C. Teratology studies have been performed in rats at subcutaneous doses in a range of 1 to 15 mg/kg/day (about 0.3 to 4 times the recommended human dose based on body surface area) and in rabbits at IV doses in a range of 0.6 to 6 mg/kg/day (about 0.3 to 3 times the recommended human dose based on body surface area) and have revealed desirudin to be teratogenic. Observed teratogenic findings were: omphalocele, asymmetric and fused sternebrae, edema, shortened hind limbs, etc. in rats; and spina bifida, malrotated hind limb, hydrocephaly, gastroschisis, etc. in rabbits. There are no adequate and well controlled studies in pregnant women. Iprivask should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

===Nursing Mothers===

It is not known whether desirudin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when desirudin is administered to a nursing woman.

===Pediatric Use===

Safety and effectiveness in pediatric patients have not been established.

===Geriatric Use===

In three clinical studies of Iprivask, the percentage of patients greater than 65 years of age treated with 15 mg of Iprivask subcutaneously every 12 hours was 58.5%, while 20.8% were 75 years of age or older. Elderly patients treated with Iprivask had a reduction in the incidence of [[VTE]] similar to that observed in the younger patients, and a slightly lower incidence of [[VTE]] compared to those patients treated with heparin or enoxaparin.

Regarding safety, in the clinical studies the incidence of hemorrhage (major or otherwise) in patients 65 years of age or older was similar to that in patients less than 65 years of age. In addition, the elderly had a similar incidence of total, treatment-related, or serious adverse events compared to those patients less than 65 years of age. Serious adverse events occurred more frequently in patients 75 years of age or older as compared to those less than 65 years of age. In general, 15 mg desirudin every 12 hours can be used safely in the geriatric population as in the population of patients less than 65 years of age so long as renal function is adequate.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = IPRIVASK (DESIRUDIN) KIT [MARATHON PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d768eca6-b25d-4aec-905f-b6a89e89ff29 | publisher =  | date =  | accessdate = 3 February 2014 }}</ref>

==References==

{{Reflist|2}}

[[Category:Direct thrombin (II) inhibitors]]
[[Category:Anticoagulants]]
[[Category:Cardiovascular Drugs]]
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