Data from FDA - Curated by Marshall Pearce - Last updated 09 September 2017

Indication(s)

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 were 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.

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Advisory information

contraindications
CONTRAINDICATIONS Hypersensitivity to this product.
Special warnings and precautions
PRECAUTIONS General There are no reports of hypersensitivity in patients who have been administered trientine hydrochloride for Wilson's disease. However, there have been reports of asthma, bronchitis and dermatitis occurring after prolonged environmental exposure in workers who use trientine hydrochloride as a hardener of epoxy resins. Patients should be observed closely for signs of possible hypersensitivity. Information for Patients Patients should be directed to take Trientine Hydrochloride Capsules 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. Because of the potential for contact dermatitis, any site of exposure to the capsule contents should be washed with water promptly. For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption. Laboratory Tests The most reliable index for monitoring treatment is the determination of free copper in the serum, which equals the difference between quantitatively determined total copper and ceruloplasmin-copper. Adequately treated patients will usually have less than 10 mcg free copper/dL of serum. Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6-12 months). Urine must be collected in copper-free glassware. Since a low copper diet should keep copper absorption down to less than one milligram a day, the patient probably will be in the desired state of negative copper balance if 0.5 to 1.0 milligram of copper is present in a 24-hour collection of urine. Drug Interactions In general, mineral supplements should not be given since they may block the absorption of Trientine Hydrochloride Capsules. 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 Capsules each inhibit absorption of the other, two hours should elapse between administration of Trientine Hydrochloride Capsules and iron. It is important that Trientine Hydrochloride Capsules 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Data on carcinogenesis, mutagenesis, and impairment of fertility are not available. 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. Trientine Hydrochloride Capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 Trientine Hydrochloride Capsules are administered to a nursing mother. Pediatric Use Controlled studies of the safety and effectiveness of Trientine Hydrochloride Capsules in pediatric patients have not been conducted. It has been used clinically in pediatric patients as young as 6 years with no reported adverse experiences. Geriatric Use Clinical studies of Trientine Hydrochloride Capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience is insufficient to determine differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse reactions
ADVERSE REACTIONS Clinical experience with Trientine Hydrochloride Capsules 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 Capsules are 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 Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing 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 500-750 mg/day for pediatric patients and 750-1250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under. The daily dose of Trientine Hydrochloride Capsules 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 6-12 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.
Pregnancy and 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 Trientine Hydrochloride Capsules are administered to a nursing mother.

Interactions

Drug Interactions In general, mineral supplements should not be given since they may block the absorption of Trientine Hydrochloride Capsules. 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 Capsules each inhibit absorption of the other, two hours should elapse between administration of Trientine Hydrochloride Capsules and iron. It is important that Trientine Hydrochloride Capsules 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.

More information

Category Value
Authorisation number NDA019194
Agency product number HC3NX54582
Orphan designation No
Product NDC 68682-212
Date Last Revised 01-11-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 313472
Storage and handling STORAGE Keep container tightly closed. Store at 2° to 8°C (36° to 46°F). Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada ©Valeant Pharmaceuticals North America LLC Rev. 11/2016 9561201 20001743
Marketing authorisation holder Oceanside Pharmaceutials