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Triptorelin Pregnancy and Breastfeeding Warnings

Triptorelin is also known as: Trelstar, Trelstar Depot, Trelstar LA, Triptodur

Triptorelin Pregnancy Warnings

Animal studies during organogenesis showed embryo-fetal toxicities of pre-implantation loss, increased resorption, and reduced number of viable fetuses. There are no adequate or well-controlled studies in pregnant women. Expected treatment related hormonal changes increase the risk for pregnancy loss.

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 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.

Use is contraindicated. (US)
Some formulations are not indicated for use in female patients; formulations approved for use in females are contraindicated during pregnancy. (UK)
This drug is not indicated for use in female patients. (AU)

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

Comments:
-Rule out pregnancy prior to treatment.
-Women of childbearing potential should use effective non-hormonal contraception during therapy until menses resume.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

See references

Triptorelin Breastfeeding Warnings

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: There is a potential for serious adverse reactions in nursing infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Trelstar (triptorelin)" Pharmacia and Upjohn, Kalamazoo, MI.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Elefant E, Biour B, Blumberg-Tick J, Roux C, Thomas F "Administration of a gonadotropin-releasing hormone agonist during pregnancy: follow-up of 28 pregnancies exposed to triptoreline." Fertil Steril 63 (1995): 1111-3
  5. Chardonnens D, Sylvan K, Walker D, Bischof P, Sakkas D, Campana A "Triptorelin acetate administration in early pregnancy: case reports and review of the literature." Eur J Obstet Gyn Reprod Biol 80 (1998): 143-9

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Trelstar (triptorelin)" Pharmacia and Upjohn, Kalamazoo, MI.

Further information

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

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