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Rolapitant Pregnancy and Breastfeeding Warnings

Rolapitant is also known as: Varubi

Rolapitant Pregnancy Warnings

The manufacturer makes no recommendation on use during pregnancy due to lack of available data to inform any drug associated risks. US FDA pregnancy category: Not Assigned

Animal studies did not reveal any teratogenic or embryofetal effects at doses up to 2.9 times the maximum recommended human dose. However, maternal toxicity was evident based on mortality/moribund condition, decreased body weight and food consumption, total litter loss, prolonged parturition, decreased gestation length, and increased number of unaccounted for implantation sites. There are no controlled data in human pregnancy. Animal fertility studies showed a transient decrease in maternal body weight gain, increases in pre- and post-implantation loss, and slight decreases in number of corpora lutea in females but no effect on the fertility or general reproductive performance of males. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Rolapitant Breastfeeding Warnings

After administration of a single oral dose equivalent to 22.5 mg/kg rolapitant free base, the mean milk/plasma radioactivity concentration ratios 1 to 48 hours post-dose in lactating rats were 1.24 to 3.25. Based on average daily consumption of milk (2 mL/day) and the maximum milk radioactivity determined, offspring exposure is expected to be 0.32% of the dose.

Benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Yes

See references

References for pregnancy information

  1. "Product Information. Varubi (rolapitant)." Tesaro Inc., Waltham, MA.

References for breastfeeding information

  1. "Product Information. Varubi (rolapitant)." Tesaro Inc., Waltham, MA.

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