Fondaparinux nonclinical toxicology: Difference between revisions
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Ahmed Zaghw (talk | contribs) Created page with "__NOTOC__ {{Fondaparinux}} {{CMG}}; {{AE}} {{AZ}} <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTIO..." |
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{{CMG}}; {{AE}} {{AZ}} | {{CMG}}; {{AE}} {{AZ}} | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | ==Nonclinical Toxicology== | ||
:*'''Carcinogenesis''' | |||
:*'''Mutagenesis''' | |||
:*'''Impairment of Fertility''' | |||
No long-term studies in animals have been performed to evaluate the carcinogenic potential of fondaparinux sodium. | |||
Fondaparinux sodium was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, the human lymphocyte chromosome aberration test, the rat hepatocyte unscheduled DNA synthesis (UDS) test, or the rat micronucleus test. | |||
At subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area), fondaparinux sodium 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 = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 23:46, 5 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Nonclinical Toxicology
- Carcinogenesis
- Mutagenesis
- Impairment of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of fondaparinux sodium.
Fondaparinux sodium was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, the human lymphocyte chromosome aberration test, the rat hepatocyte unscheduled DNA synthesis (UDS) test, or the rat micronucleus test.
At subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area), fondaparinux sodium was found to have no effect on fertility and reproductive performance of male and female rats.[1]
References
Adapted from the FDA Package Insert.