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Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's and Trientine-DRLA
Published
Product name
Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's and Trientine-DRLA
Active ingredient
Trientine dihydrochloride
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's and Trientine-DRLA (trientine dihydrochloride) was approved for the following therapeutic use:
Trientine dihydrochloride capsules are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine.
How this medicine works
Wilson's disease (hepatolenticular degeneration) is an autosomal inherited metabolic defect resulting in an inability to maintain a near zero balance of copper. Excess copper accumulates possibly because the liver lacks the mechanism to excrete free copper into the bile. Hepatocytes store excess copper but when their capacity is exceeded copper is released into the blood and is taken up into extrahepatic sites. This condition is treated with a low copper diet and the use of chelating agents that bind copper to facilitate its excretion from the body.[1] Trientine is a copper chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion. Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.
Footnotes
[1] Hedera, P. Wilson's Disease: A Master of Disguise, Parkinsonism Relat Disord, 2019; 59: 140-145.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's and Trientine-DRLA was considered favourable for the therapeutic use approved.
ARTG details