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NUVIGIL (ARMODAFINIL) TABLETS: USE IN SPECIAL POPULATIONS

Pregnancy

Pregnancy Category C.

In studies conducted in rats (armodafinil, modafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant exposures.

Oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout the period of organogenesis resulted in increased incidences of fetal visceral and skeletal variations at the intermediate dose or greater and decreased fetal body weights at the highest dose. The no-effect dose for rat embryofetal developmental toxicity was associated with a plasma armodafinil exposure (AUC) approximately 0.03 times the AUC in humans at the maximum recommended daily dose of 250 mg.

Modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout the period of organogenesis caused, in the absence of maternal toxicity, an increase in resorptions and an increased incidence of visceral and skeletal variations in the offspring at the highest dose. The higher no-effect dose for rat embryofetal developmental toxicity was associated with a plasma modafinil exposure approximately 0.5 times the AUC in humans at the recommended daily dose (RHD) of 200 mg. However, in a subsequent study of up to 480 mg/kg/day (plasma modafinil exposure approximately 2 times the AUC in humans at the RHD) no adverse effects on embryofetal development were observed.

Modafinil administered orally to pregnant rabbits throughout the period of organogenesis at doses of up to 100 mg/kg/day (plasma modafinil AUC approximately equal to the AUC in humans at the RHD) had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of modafinil on embryofetal development. In a subsequent developmental toxicity study evaluating doses of 45, 90, and 180 mg/kg/day in pregnant rabbits, the incidences of fetal structural alterations and embryofetal death were increased at the highest dose. The highest no-effect dose for developmental toxicity was associated with a plasma modafinil AUC approximately equal to the AUC in humans at the RHD.

Modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day (plasma modafinil AUC approximately 0.1 times the AUC in humans at the RHD). No effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring.

There are no adequate and well-controlled studies of either armodafinil or modafinil in pregnant women. Two cases of intrauterine growth retardation and one case of spontaneous abortion have been reported in association with armodafinil and modafinil. Although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class.

Certain of these drugs have been associated with intrauterine growth retardation and spontaneous abortions. Whether the cases reported with Armodafinil (Nuvigil) tablets are drug-related is unknown.

Armodafinil or modafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pregnancy Registry: A pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to Nuvigil (Armodafinil). Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry in their local living areas.

Labor and Delivery

The effect of armodafinil on labor and delivery in humans has not been systematically investigated.

Nursing Mothers

It is not known whether Armodafinil (Nuvigil) or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nuvigil tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of armodafinil use in individuals below 17 years of age have not been established. Serious rash has been seen in pediatric patients receiving modafinil.

Geriatric Use

In elderly patients, elimination of Armodafinil (Nuvigil) and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.

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