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Rolapitant Pregnancy and Breastfeeding Warnings

Rolapitant is also known as: Varubi, Varubi IV

Medically reviewed by Drugs.com. Last updated on Apr 10, 2019.

Rolapitant Pregnancy Warnings

Use is not recommended unless clearly needed.

US FDA pregnancy category: Not Assigned

Risk Summary: Limited data in pregnant women are insufficient to inform of a drug-related risk.

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 postimplantation 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

A single, 22.5 mg/kg oral dose given to a lactating animal model produced a mean milk/plasma radioactivity concentration ratio at 1 to 48 hours post-dose of 1.24 to 3.25. Offspring exposure was expected to be 0.32% of the dose, and was based on the maximum milk radioactivity and average daily consumption of milk (2 mL/day).

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Varubi (rolapitant)." Tesaro Inc., Waltham, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.