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SAVELLA (MILNACIPRAN): NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis

Dietary administration of milnacipran to rats at doses of 50 mg / kg per day (2 times the MRHD on a mg / m2 basis) for 2 years caused a statistically significant increase in the incidence of thyroid C-cell adenomas and combined adenomas and carcinomas in males. A carcinogenicity study was conducted in Tg.rasH2 mice for 6 months at oral gavage doses of up to 125 mg / kg per day. Milnacipran did not induce tumors in Tg.rasH2 mice at any dose tested.

Mutagenesis

Milnacipran (Savella) was not mutagenic in the in vitro bacterial reverse mutation assay (Ames test) or in the L5178Y TK +/- mouse lymphoma forward mutation assay. Milnacipran was also not clastogenic in an in vitro chromosomal aberration test in human lymphocytes or in the in vivo mouse micronucleus assay.

Impairment of Fertility

Although administration of milnacipran to male and female rats had no statistically significant effect on mating or fertility at doses up to 80 mg / kg per day (4 times the MRHD on an mg / m2 basis) there was an apparent dose-related decrease in the fertility index at clinically relevant doses based on body surface area.

Animal Toxicology and Pharmacology

Hepatic Effects

Chronic administration (2-years) of milnacipran to rats at 15 mg / kg (0.6 times the MRHD on an mg / m2 basis) and higher doses showed increased incidences of centrilobular vacuolation of the liver in male rats and eosinophilic foci in male and female rats in the absence of any change in hepatic enzymes. The clinical significance of the finding is not known. Chronic (1-year) administration in the primate at doses up to 25 mg / kg (2 times the MRHD on a mg / m2 basis) did not demonstrate similar evidence of hepatic changes.

Ocular Effects

Chronic (2-years) administration of milnacipran to rats at 15 mg / kg (0.6 times the MRHD on a mg / m2 basis) and higher doses showed increased incidence of keratitis of the eye. One year studies in the rat and primate did not show this response.

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