Wilson’s disease (WD), the most common inherited disorder of copper metabolism, results from a failure of the copper excretory pathway. This leads to toxic accumulation of copper in the liver and eventually other organs. The worldwide prevalence of WD is estimated to be one in 30,000 individuals. The condition can be treated with a low copper diet and chelating agents that bind copper to facilitate its excretion from the body. Trientine hydrochloride Capsules is a chelating agent indicated for treatment of patients with WD who are intolerant of the first-line treatment, penicillamine.Download Trientine Hydrochloride Capsules 250mg Patient leaflet.
Trientine hydrochloride Capsules (trientine hydrochloride) is 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 is 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 is not indicated for treatment of biliary cirrhosis.
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• Trientine hydrochloride Capsules is contraindicated in patients hypersensitive to Trientine hydrochloride Capsules or any components of the formulation. Patients should be observed closely for signs of possible hypersensitivity.
• Patients receiving Trientine hydrochloride Capsules 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.
• The treatment can be monitored by the determination of free copper in the serum. Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6-12 months).
• 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. 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.
• In general, mineral supplements should not be given since they may block the absorption of Trientine hydrochloride Capsules.
• Trientine hydrochloride Capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• The following adverse reactions have been reported in a clinical study: iron deficiency, systemic lupus erythematosus. In addition, dystonia, muscular spasm, myasthenia gravis have been reported in marketed use.
Please click here to see full Prescribing Information for Trientine hydrochloride Capsules.
“Treatment of patients with Trientine Hydrochloride Capsules may be complicated by severe, sometimes lifethreatening, adverse effects. Trientine Hydrochloride Capsules should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.”
“Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukaemia’s have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient's underlying disease. The physician and patient must very carefully consider the potential benefits of Trientine Hydrochloride Capsules relative to the undefined risk of developing secondary malignancies. Trientine Hydrochloride Capsules is used to treat chronic myeloid leukaemia or cervical cancer.”
“Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered. How well you feel and how you are likely to cope with treatment is also important.”
“Your cancer treatment will usually consist of a treatment session with Trientine Hydrochloride Capsules followed by a break of a number of days before the next treatment session with Trientine Hydrochloride Capsules. This cycle may be repeated many times as part of your cancer treatment. Trientine Hydrochloride Capsules works by damaging cancer cells in the body. Trientine Hydrochloride Capsules also affects healthy cells and treatment with Trientine Hydrochloride Capsules may damage your immune system. Your medical team may arrange for you to have some blood tests to check how well your immune system is working. Do not share your medicine with other people. It may not be suitable for them and may harm them. The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber. If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.