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Trientine Pregnancy and Breastfeeding Warnings

Brand names: Clovique, Cuvrior, Syprine

Medically reviewed by Drugs.com. Last updated on May 14, 2024.

Trientine Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: This drug can cause fetal harm when administered to pregnant patients; it has been shown to be teratogenic in animal studies.

Comments:
-Monitor during pregnancy for fetal abnormalities and maternal serum copper.
-Adjust dose to maintain serum copper levels in the normal range.

Animal studies showed teratogenicity (resorptions, fetal abnormalities, hemorrhage, and edema) at doses similar to human doses. There are no controlled data in human pregnancy.

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

Trientine Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Monitor babies for serum copper and ceruloplasmin levels where appropriate.
-This drug has a low molecular weight and excretion into breast milk is expected.

See references

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References for pregnancy information

  1. (2001) "Product Information. Syprine (trientine)." Aton Pharma
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. (2022) "Product Information. Cuvrior (trientine)." Orphalan
  4. (2023) "Product Information. Trientine Hydrochloride (trientine)." Rising Pharma Holdings Inc
  5. (2020) "Product Information. Syprine (trientine)." Bausch Health US (formerly Valeant Pharmaceuticals)

References for breastfeeding information

  1. (2001) "Product Information. Syprine (trientine)." Aton Pharma
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

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