Skip to main content

Nintedanib Pregnancy and Breastfeeding Warnings

Brand names: Ofev

Nintedanib Pregnancy Warnings

According to some authorities: Use is contraindicated during pregnancy

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Advise pregnant women of the potential risk to a fetus if this drug is used during pregnancy.
-Pregnancy testing must be performed before starting treatment (and during therapy, if appropriate).
-Counsel females of childbearing potential to avoid pregnancy by using effective contraception at initiation of, during treatment, and for at least 3 months after the last dose of this drug.
-Instruct patients to notify their health care provider if they become pregnant during therapy.
-This drug does not affect plasma exposure to oral hormonal contraceptives; however, oral contraceptive efficacy may be compromised by adverse reactions that impair absorption (e.g., vomiting, diarrhea).
-If this drug is given concomitantly with docetaxel, refer to the docetaxel manufacturer product information for pregnancy-related considerations.

Animal studies have revealed evidence of embryofetal lethality and teratogenicity. Embryofetal deaths and structural abnormalities occurred after administration of this drug to pregnant animals at exposures ranging from significantly below to up to 5 times the maximum recommended human dose. Malformations included abnormalities in the vasculature, urogenital, and skeletal systems. Based on animal data, this drug may reduce fertility in females of reproductive potential. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Nintedanib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-There is no information on the presence of this drug in human milk or the effects on milk production.
-According to some experts: Because this drug is highly protein bound, the amount in milk is expected to be low. However, there is a potential for accumulation in the nursing infant due to a long drug half-life.
-If this drug is given concomitantly with docetaxel, refer to the docetaxel manufacturer product information for lactation-related considerations.

See references

References for pregnancy information

  1. (2022) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim
  2. (2024) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim Pty Ltd
  3. (2023) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim Ltd
  4. (2023) "Product Information. Vargatef (nintedanib)." Boehringer Ingelheim Ltd

References for breastfeeding information

  1. (2022) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim
  2. (2024) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim Pty Ltd
  3. (2023) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim Ltd
  4. (2023) "Product Information. Vargatef (nintedanib)." Boehringer Ingelheim Ltd
  5. Bethesda (MD): National Institute of Child Health and Human Development (US) (2024) Nintedanib - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK500862/

Further information

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