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Nintedanib Pregnancy and Breastfeeding Warnings

Nintedanib is also known as: Ofev

Nintedanib Pregnancy Warnings

Animal studies have demonstrated embryofetal death and teratogenicity. There are no controlled data in human pregnancy. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use should be avoided. US FDA pregnancy category: D Comments: Women should use adequate methods of contraception during treatment and at least 3 months after last dose. Pregnancy testing should be conducted at least prior to initiation of treatment.

See references

Nintedanib Breastfeeding Warnings

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 Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Ofev (nintedanib)." Boehringer Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Ofev (nintedanib)." Boehringer Ingelheim, Ridgefield, CT.

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