Desirudin nonclinical toxicology: Difference between revisions

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(Created page with "__NOTOC__ {{Desirudin}} {{CMG}}; {{AE}} {{SS}} ==Nonclinical Toxicology== ===General Toxicity=== Desirudin produced bleeding, local inflammation, and granulation at injecti...")
 
 
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==Nonclinical Toxicology==
 
===General Toxicity===
 
Desirudin produced bleeding, local inflammation, and granulation at injection sites in rat and dog toxicity studies. In a 28-day study in Rhesus monkeys, there was also evidence of subcutaneous bleeding and local inflammation at the injection sites. In addition, desirudin was immunogenic in dogs and formed antibody complexes resulting in prolonged half-life and accumulation. Desirudin showed sensitization potential in guinea pig immediate and delayed hypersensitivity models.
 
===Carcinogenesis, Mutagenesis, Impairment of Fertility===
 
No long-term studies in animals have been performed to evaluate the carcinogenic potential of desirudin.
 
Desirudin was not genotoxic in the Ames test, the Chinese hamster lung cell (V79/HGPRT) forward mutation test or the rat micronucleus test. It was, however, equivocal in its genotoxic effect in Chinese hamster ovarian cell (CCL 61) chromosome aberration tests.
 
Desirudin at subcutaneous doses up to 10mg/kg/day (about 2.7 times the recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
 
<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 22:29, 21 July 2014