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TRIENTINE HYDROCHLORIDE

Generic: TRIENTINE HYDROCHLORIDE

Verified·Apr 23, 2026
Manufacturer
Bausch Health
NDC
49884-060
ICD-10 indication
E83.01

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About TRIENTINE HYDROCHLORIDE

What is this medication? Trientine hydrochloride is a prescription pharmaceutical used to manage a rare genetic condition known as Wilsons disease. In individuals with this disorder, the body is unable to properly eliminate copper, leading to a dangerous buildup of the metal in the liver, brain, and other vital organs. As a chelating agent, trientine works by binding to excess copper in the body and helping the kidneys flush it out through the urine.

This medication is generally reserved for patients who cannot tolerate penicillamine, which is often the initial treatment for Wilsons disease. By reducing copper levels, trientine helps prevent long-term damage to the nervous system and liver. It is essential for patients to follow their healthcare providers instructions closely, as effective treatment usually involves long-term management and frequent blood or urine tests to track copper concentration.

Copay & patient assistance

  • Patient Copay Amount: $0 (Free for eligible patients)
  • Maximum Annual Benefit Limit: Not Publicly Available (Patients can receive medication for up to 1 year per approval)
  • Core Eligibility Restrictions: Patients must have limited or no insurance coverage, or be Medicaid patients whose plan has stopped covering Bausch Health medications; must have a valid prescription and meet financial eligibility requirements.
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for TRIENTINE HYDROCHLORIDE. Official source: DailyMed (NLM) · Label effective Nov 29, 2024

Indications and usage
INDICATIONS AND USAGE Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride capsules was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.
Dosage and administration
DOSAGE AND ADMINISTRATION Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of trientine hydrochloride capsules is 500 to 750 mg/day for pediatric patients and 750 to 1,250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2,000 mg/day for adults or 1,500 mg/day for pediatric patients age 12 or under. The daily dose of trientine hydrochloride should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6 to 12 month intervals (see PRECAUTIONS , Laboratory Tests ). It is important that trientine hydrochloride capsules be given 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. The capsules should be swallowed whole with water and should not be opened or chewed.
Contraindications
CONTRAINDICATIONS Hypersensitivity to this product.
Warnings
WARNINGS Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY ). Patients receiving trientine hydrochloride should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.
Adverse reactions
ADVERSE REACTIONS Clinical experience with trientine hydrochloride has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis. Trientine hydrochloride is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established. To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use in pregnancy
Drug Interactions In general, mineral supplements should not be given since they may block the absorption of trientine hydrochloride. 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 trientine hydrochloride each inhibit absorption of the other, two hours should elapse between administration of trientine hydrochloride and iron. It is important that trientine hydrochloride 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.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How TRIENTINE HYDROCHLORIDE appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

68%

3,725 of 5,509 plans

Most common tier

Tier 5

On 72% of covering formularies

Prior authorization required

87%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)76
23%
Tier 2 (generic)2
1%
Tier 4 (non-preferred brand)12
4%
Tier 5 (specialty)238
72%
Tier 61
0%

Step therapy: 1% of formularies

Quantity limits: 50% of formularies

Coverage breadth: 329 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Medicare Part D

Medicare Part D

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.

Rare-disease navigation (specialists, trials, patient communities)

TRIENTINE HYDROCHLORIDE treats a rare condition. For in-depth disease pages on our sister site:

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