Desirudin use in specific populations: Difference between revisions

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(Created page with "__NOTOC__ {{Desirudin}} {{CMG}}; {{AE}} {{SS}} ==Use In Specific Populations== ===Pregnancy=== Teratogenic Effects: Pregnancy Category C. Teratology studies have been perfor...")
 
 
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__NOTOC__
#REDIRECT [[Desirudin#Use in Specific Populations]]
{{Desirudin}}
{{CMG}}; {{AE}} {{SS}}
 
==Use In Specific Populations==
===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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Latest revision as of 22:30, 21 July 2014