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Regorafenib Pregnancy and Breastfeeding Warnings

Regorafenib is also known as: Stivarga

Medically reviewed on May 15, 2017

Regorafenib Pregnancy Warnings

Animal studies have revealed evidence of embryolethality and teratogenicity at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations. Adverse fetal effects included increased drug penetration across the blood-brain barrier, delayed ossification, and dose-dependent increases in the incidence of cleft palate, enlarged fontanelle, diaphragmatic hernia, renal pelvis dilation, missing kidney/ureter, small/deformed/malpositioned kidney, and hydronephrosis. Additionally, the proportion of viable male fetuses decreased with increasing dose.

Animal findings also indicate this drug may adversely affect male and female reproduction; findings included partially reversible morphological changes in the testes, ovaries, and the uterus after repeated dosing at exposures below the anticipated human exposure. There are no controlled data in human pregnancy or human fertility.

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.

This drug should not be used during pregnancy unless clearly necessary, and the benefits outweigh the risks.

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

Comments:
-Based on animal studies and its mechanism of action, this drug may cause fetal harm.
-This drug and its metabolites have been shown to cross the placenta in animals.
-Advise pregnant women of the potential fetal risks of this drug, and instruct females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 8 weeks after therapy completion.

See references

Regorafenib Breastfeeding Warnings

Due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for 2 weeks after the final dose of this drug.

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

Comments: The drug amount in human breastmilk is likely to be low as this drug is more than 99.5% bound to plasma proteins; however, there may be drug accumulation in a breastfed infant due to the long half-life (32 to 100 hours) of one of the active drug metabolites.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Stivarga (regorafenib)." Bayer Pharmaceutical Inc, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Stivarga (regorafenib)." Bayer Pharmaceutical Inc, West Haven, CT.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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