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Armodafinil Pregnancy and Breastfeeding Warnings

Armodafinil is also known as: Nuvigil

Armodafinil Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus. US FDA pregnancy category: C Comments: There is a potential increased risk of pregnancy when using steroidal contraceptives (including depot or implantable contraceptives) with this drug and for 1 month after treatment discontinuation.

Intrauterine growth restriction and spontaneous abortion have been reported with this drug and modafinil. In animal studies for this drug, developmental toxicity (increased fetal visceral and skeletal variations, decreased fetal body weight) was observed at clinically relevant plasma exposures and at a dose of 600 mg/kg/day. Animal studies for modafinil have also revealed development toxicity at doses from 20 to 200 mg/kg/day; however, a study with a 480 mg/kg/day dose demonstrated no adverse effects on embryofetal development. Fertility information is not available for this drug, but oral administration of modafinil produced an increase in the time to mate at the 480 mg/kg/day dose; no other fertility effects were observed. There are no controlled data in human pregnancy. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Healthcare providers are encouraged to register pregnant patients, and pregnant women are encouraged to enroll themselves by calling 1-866-404-4106 (toll free). US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Armodafinil Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Nuvigil (armodafinil)." Cephalon Inc, West Chester, PA.

References for breastfeeding information

  1. "Product Information. Nuvigil (armodafinil)." Cephalon Inc, West Chester, PA.

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