Trientine

FDA label, Bausch Health US LLC, oral, effective 2020-09-01. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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  • Trientine
Label text (2 paragraphs)

Drug Interactions In general, mineral supplements should not be given since they may block the absorption of Syprine. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson’s disease. If necessary, iron may be given in short courses, but since iron and Syprine each inhibit absorption of the other, two hours should elapse between administration of Syprine and iron. It is important that Syprine be taken on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk.

This permits maximum absorption and reduces the likelihood of inactivation of the drug by metal binding in the gastrointestinal tract.

Contraindications

Hypersensitivity to this product.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

E

Likelihood score E: Unlikely cause of clinically apparent liver injury.

Trientine is an oral copper chelating agent used to treat Wilson disease. Trientine has not been associated with worsening of serum enzyme elevations during therapy or with cases of clinically apparent liver injury with jaundice.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Trientine (NIDDK, public domain)Chapter updated Jul 25, 2020

Pregnancy and lactation

Pregnancy

Pregnancy Trientine hydrochloride was teratogenic in rats at doses similar to the human dose. The frequencies of both resorptions and fetal abnormalities, including hemorrhage and edema, increased while fetal copper levels decreased when trientine hydrochloride was given in the maternal diets of rats. There are no adequate and well-controlled studies in pregnant women. Syprine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Syprine is administered to a nursing mother.

Breastfeeding (LactMed)

Limited information indicates that trientine is not detectable in breastmilk, and no adverse effects have been reported among breastfed infants whose mothers were taking the drug. The effect of trientine on breastmilk copper and zinc concentrations in milk is somewhat conflicting,-but breastfed infants appear to have normal serum copper and zinc plasma levels. Based on available data, it appears that trientine is acceptable to use during breastfeeding.

Alternatives LactMed suggests considering:
Source: LactMed: Trientine (NICHD, public domain)Revised Aug 15, 2024

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