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Lutropin alfa Pregnancy and Breastfeeding Warnings

Brand names: Luveris

Lutropin alfa Pregnancy Warnings

Use is contraindicated

AU TGA pregnancy category: B3
US FDA pregnancy category: X

Comments: There is no indication for use of this drug during pregnancy.

Animal data has not shown teratogenicity. Administration to rats from late gestation to weaning resulted in adverse effects on the post-natal survival and growth of offspring. Data on a limited number of human pregnancies inadvertently exposed following controlled ovarian stimulation have shown no adverse reactions of gonadotrophins on pregnancy, embryo or fetal development, parturition or postnatal development. Data are insufficient to exclude a teratogenic effect. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Lutropin alfa Breastfeeding Warnings

Use is contraindicated

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

Comments: According to product manufacturers, this product should not be used in breastfeeding women.

See references

See also

References for pregnancy information

  1. (2004) "Product Information. Luveris (lutropin alfa)." Serono Laboratories Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. Cerner Multum, Inc. (2015) "Canadian Product Information."

References for breastfeeding information

  1. (2004) "Product Information. Luveris (lutropin alfa)." Serono Laboratories Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. Cerner Multum, Inc. (2015) "Canadian Product Information."

Further information

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

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