Trientine Tetrahydrochloride — Active Pharmaceutical Ingredient

Trientine Tetrahydrochloride is an active pharmaceutical ingredient found in 1 FDA-approved drug product. Forms: TABLET. Routes: ORAL.

This content is for informational purposes only. Always consult a healthcare professional.

Trientine Tetrahydrochloride (1 brand name, 1 dosage form, 1 route)

Available dosage forms: TABLET.

Routes of administration: ORAL.

Brand Names

  • CUVRIOR

Indications and Usage

CUVRIOR is indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.

Contraindications

CUVRIOR is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in CUVRIOR [see Warnings and Precautions (5.4)].

Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Potential for Worsening of Clinical Symptoms at Initiation of Therapy [see Warnings and Precautions (5.1)] Copper Deficiency [see Warnings and Precautions (5.2)] Iron Deficiency [see Warnings and Precautions (5.3)] Hypersensitivity Reactions [see Warnings and Precautions (5.4)]

Mechanism of Action

Trientine, a copper chelator, eliminates absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion. Trientine also chelates copper in the intestinal tract, reducing copper absorption.

Overdosage

Occasional cases of trientine overdose have been reported. A large overdose of 60 g of trientine hydrochloride (equivalent to 80 g CUVRIOR) resulted in nausea, vomiting, dizziness, mild acute kidney injury, mild hypophosphatemia, low serum zinc, and low serum copper. The patient recovered following intravenous hydration and supportive measures. There is no antidote for trientine acute overdose. Chronic use of trientine hydrochloride at dosages above the maximum recommended dosage has resulted in sideroblastic anemia.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.