Skip to Content

Pazopanib Pregnancy and Breastfeeding Warnings

Pazopanib is also known as: Votrient

Medically reviewed on August 3, 2017

Pazopanib Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments: Women of childbearing potential should be advised to use adequate contraception during drug therapy and for 4 weeks after therapy, and avoid becoming pregnant while receiving drug treatment.

Animal studies revealed evidence of teratogenicity, embryotoxicity, embryolethality, fetotoxicity, maternal toxicity, reduced maternal and fetal weight, cardiovascular malformations, incomplete or absent ossification, increased pre- and post-implantation loss, early resorptions, and abortifacient properties. There are no controlled data in human pregnancy.

The drug may impair fertility in humans. Animal reproductive studies have shown reduced fertility, decreased corpora lutea, and increased incidence of ovarian cysts and atrophy in females. Reductions in sperm production rates, sperm motility, epididymal and testicular sperm concentrations, atrophy and degeneration of the testes have been observed in males.

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 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.

See references

Pazopanib 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: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Votrient (pazopanib)." GlaxoSmithKline, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Votrient (pazopanib)." GlaxoSmithKline, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. 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.

Hide