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Molecule

Trientine tetrahydrochloride

Copper Chelator
Available on requestOrphan
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Trientine tetrahydrochloride is a copper chelator indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. It is available as tablets for oral use. MedsAcross supplies Trientine tetrahydrochloride for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Copper Chelator, Copper Chelating Activity, Metal Chelating Activity
US FDA first approval
28 April 2022
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 7360URE56QCAS 4961-40-4Q27266138

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

Recommended Dosage and Administration Starting total daily dosage of CUVRIOR in adults is 300 mg up to 3,000 mg orally in divided doses (2 times daily). See full prescribing information for recommended conversion table when switching from penicillamine to CUVRIOR. Total daily dosage of CUVRIOR should not exceed 3,000 mg. If the number of CUVRIOR tablets prescribed per day cannot be equally divided among doses, then divide total daily dosage such that the higher number of tablets is taken with the first daily dose. Take CUVRIOR on an empty stomach. Swallow tablets without crushing, chewing, or dissolving tablets. Switching from Other Trientine Products CUVRIOR is not substitutable on a milligram-per-milligram basis with other trientine products. See full prescribing information for additional information on switching from other trientine products.

Source: US FDA prescribing information

Contraindications

CUVRIOR is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in CUVRIOR. Hypersensitivity to trientine or to any of the excipients in CUVRIOR.

Source: US FDA prescribing information

Warnings and precautions

Potential for Worsening of Clinical Symptoms at Initiation of Therapy: May include neurological deterioration. Adjust dosage or discontinue CUVRIOR if clinical condition worsens. Copper Deficiency: Periodic monitoring is required. Iron Deficiency: If iron deficiency develops, a short course of iron supplementation may be given. Hypersensitivity Reactions: If rash or other hypersensitivity reaction occurs, consider discontinuing CUVRIOR.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Potential for Worsening of Clinical Symptoms at Initiation of Therapy Copper Deficiency Iron Deficiency Hypersensitivity Reactions Most common adverse reactions (>5%) are abdominal pain, change of bowel habits, rash, alopecia, and mood swings.

Source: US FDA prescribing information

Interactions

Mineral Supplements (e.g. iron, zinc, calcium, magnesium): Avoid concomitant use. If concomitant use is unavoidable: Iron: Take CUVRIOR at least 2 hours before or 2 hours after iron. Other Mineral Supplements: Take CUVRIOR at least 1 hour before or 2 hours after other mineral supplements. Other Drugs for Oral Administration: Take CUVRIOR at least 1 hour apart from any other oral drug.

Source: US FDA prescribing information

Storage

Store at a controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions between 15°C and 30°C (59°F and 86°F) are permitted.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Trientine tetrahydrochloride, sorted by availability.

MedicineManufacturerRegisterAvailability
Cuvrior 300 mg tabletOralOrphalanUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 28 April 2022Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Trientine tetrahydrochloride available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Trientine tetrahydrochloride and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Trientine tetrahydrochloride have?

The catalogue lists 1 brand names for Trientine tetrahydrochloride, including Cuvrior.

Is Trientine tetrahydrochloride approved by the US FDA?

Yes. The US FDA first approved Trientine tetrahydrochloride on 28 April 2022, according to Drugs@FDA.

Does Trientine tetrahydrochloride need cold chain shipping?

No listed presentation of Trientine tetrahydrochloride is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. CUVRIOR prescribing information (Orphalan). U.S. National Library of Medicine, DailyMed. Retrieved 19 June 2025

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