Hepatocytes store excess copper but when their capacity is exceeded copper is released into the blood and is taken up into extrahepatic sites. Trientine Tetrahydrochloride WebA retrospective survey of the clinical experience of trientine in the management of Wilsons disease has been conducted with two different trientine formulations: a nationally produced tetrachloride (TETA 4HCl) formulation and trientine dihydrochloride (TETA 2HCL). WebHow to use Trientine HCL. Copyright 2023 by RxList Inc. An Internet Brands company. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia. Trientine is a chelating (KEE-late-ing) agent. WebTrientine tetrahydrochloride (brand name Cuprior) was approved for medical use in the European Union in September 2017. Cuprior is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage. Otherwise, call a poison control center right away. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under. Cuvrior tablets are administered orally two times a day on an empty stomach. Last updated by Judith Stewart, BPharm on Aug 24, 2022. What Are the Best PsA Treatments for You? For the best effect, follow a low-copper diet as directed by your doctor. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Walshe (1973) after discussing the results of a 4 year treatment on the first Wilsons disease patient successfully handled with trien, presented a comparison of the ability of H2Pen and trien to mobilize copper in a group of 18 patients. To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Trientine and zinc have become major tools in the management of Wilsons disease. There are no reports of hypersensitivity in patients who have been administered trientine hydrochloride for Wilsons disease. Evidence from a radio-labelled copper study indicates that the different cupriuretic effect between these two drugs could be due to a difference in selectivity of the drugs for different copper pools within the body. trientine tetrahydrochloride Trien 2HCl, also known as Syprine, or Trientine, has the formula C6H18N4 2HCl, and a molecular weight 219.2g/mol. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. WebA retrospective survey of the clinical experience of trientine in the management of Wilsons disease has been conducted with two different trientine formulations: a nationally produced tetrachloride (TETA 4HCl) formulation and trientine dihydrochloride (TETA 2HCL). Trientine Version: 2.01. zinc acetate, penicillamine, Cuvrior, Depen, Clovique, Galzin. Free and total serum copper, SGOT and serum bilirubin all showed mean increases over baseline in the untreated group which were significantly larger than with the patients treated with trientine hydrochloride. Cuprior contains the active substance trientine. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Triethylene tetramine dihydrochloride is used as an alternative therapy for patients who are intolerant to penicillamine (Dubois etal., 1990). Cuprior | European Medicines Agency The mechanism for these clinical signs was not clearly established as due to copper depletion (primary pharmacology) or due to other drug activity. Trientine may also be used for purposes not listed in this medication guide. Package insert / product label Follow all directions on your prescription label. Plot No.111, SIDCO Industrial Estate, Kakkalur, Thiruvallur 602 003 Tamilnadu, India. Discuss the risks and benefits with your doctor. Trientine All rights reserved. WebTRIENTINE TETRAHYDROCHLORIDE: Official Name : English : View: View: 1,2-ETHANEDIAMINE, N,N'-BIS(2-AMINOETHYL)-, TETRAHYDROCHLORIDE: Systematic Name : English : View: View: 1,2-ETHANEDIAMINE, N1,N2-BIS(2-AMINOETHYL)-, HYDROCHLORIDE (1:4) Systematic Name : English : View: View: 1,4,7,10-TETRAAZADECANE Standard deviations are shown in parentheses. For patients switching to CUVRIOR, where possible, the initial total daily dosage was determined as the trientine base in mg that was the same as the patients total daily dosage in mg of penicillamine. WebTablets: 300 mg of trientine tetrahydrochloride (equivalent to 150 mg of trientine), oblong, yellow coated, functionally scored, printed with OL75 on each side of score line in black ink. Therapy with TN results in ADRs less frequently than DPA (Roberts and Schilsky, 2008; EASL, 2012; Weiss et al., 2013a). Consult your doctor before breast-feeding. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition. Visit the FDA MedWatch website or call 1-800-FDA-1088. Before using this medication, tell your doctor or pharmacist your medical history. Dosage form: Tablets WebTrientine tetrahydrochloride (brand name Cuprior) was approved for medical use in the European Union in September 2017. Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6 to 12 months). The trientine hydrochloride group received d-penicillamine for an average of 4 years as compared to an average of 10 years for the nontreated group. Do not take trientine in larger or smaller amounts or for longer than recommended. and transmitted securely. Mean T1/2 was 19.312.3 and 11.23.30 hours for MAT and DAT, respectively. Swallow the whole or split tablet without crushing or chewing. You can findproduct informationdocuments for centrally authorised human medicines on this website. WebTablets: 300 mg of trientine tetrahydrochloride (equivalent to 150 mg of trientine), oblong, yellow coated, functionally scored, printed with OL75 on each side of score line in black ink. Single oral doses of both formulations were safe and well tolerated. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Manufactured for: This product is no longer an orphan medicine. The aim of this study was to compare the pharmacokinetics of a new trientine tetrahydrochloride formulation (TETA 4HCl) with those of an established trientine dihydrochloride (TETA 2HCl) salt. This medication and a low-copper diet may increase the risk for iron deficiency. This medication is used to treat a certain inherited disorder (Wilson's disease). If you are taking the tablet form of this medication, do not crush, chew or dissolve the tablets. 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 mg of copper is present in a 24-hour collection of urine. The effects included interstitial inflammation and alveolar histiocytic infiltration, observed at a dose approximately equal to the maximum recommended dose based on body surface area. Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. Renal clearance studies were carried out with penicillamine and trientine hydrochloride on separate occasions in selected patients treated with penicillamine for at least one year. Many people using this medication do not have serious side effects. At the start of the study, patients entered a 12-week baseline period and continued to receive their established total daily dosage of penicillamine for 12 weeks. trientine tetrahydrochloride Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. In adults, the initial dose of TN is 7501500mg/day in two or three divided doses, given on an empty stomach (1 hour before or 2 hours after a meal and at least 1 hour apart from any other drug, food, or milk). WebThis medication is used to treat a certain inherited disorder ( 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. WebTrientine is a chelating agent that binds to copper, forming a complex that is readily excreted by the kidneys; it may also inhibit the absorption of copper from the gastro-intestinal tract. Take CUVRIOR on an empty stomach (at least 1 hour before meals or 2 hours after meals and at least 1 hour apart from other food or milk). You are encouraged to report negative side effects of prescription drugs to the FDA. Wilson disease (WD) is a rare autosomal recessive genetic disorder that results in the pathological accumulation of copper in the liver, brain and other organs [ 1, 2, 3, 4 ]. WebTrientine tetrahydrochloride | C6H22Cl4N4 | CID 71434 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities, safety/hazards/toxicity information, supplier lists, and more. Other adverse effects include dyspepsia, muscle spasms, and dystonia. Bottles of 100 NDC 31722-683-01 Clinical studies of trientine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Trientine Call your doctor for medical advice about side effects. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. h/mL. In Canada - Call your doctor for medical advice about side effects. Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilsons disease who are de-coppered and tolerant to penicillamine. For further information, see the package leaflet. In children, the dosage is 20mg/kg/day rounded off to the nearest 250mg. Due to the possibility of neurologic worsening, the drug should be introduced gradually (start low and go slow) (Roberts and Schilsky, 2008; EASL, 2012). Guido Crisponi, Valeria Marina Nurchi, in Chelation Therapy in the Treatment of Metal Intoxication, 2016. The https:// ensures that you are connecting to the Do not remove tablets from the blister pack until just before dosing. Clinical Trials Number EudraCT # 2015-002199-25. The rate (maximum plasma concentration [Cmax]) and extent (area under the plasma concentration-time curve from time zero to infinity [AUC0-]) of absorption of the active moiety, trientine, were greater (by approximately 68% and 56%, respectively) for TETA 4HCl than for the TETA 2HCl formulation. Table 5: Serum NCCa and 24-Hour UCE Results at Week 36 in Trial 1, Advise patients or their caretaker(s) to [see DOSAGE AND ADMINISTRATION]. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. The adequacy of decoppering treatment with TN should be monitored as discussed for DPA by assessing the daily urine copper excretion and NCBC levels. Some minerals can make it harder for your body to absorb trientine. Trientine may cause serious side effects. WebA retrospective survey of the clinical experience of trientine in the management of Wilsons disease has been conducted with two different trientine formulations: a nationally produced tetrachloride (TETA 4HCl) formulation and trientine dihydrochloride (TETA 2HCL). Trientine Two weeks after cessation of trientine, his altered mental status and ptosis had resolved. They are supplied as follows: Figure 2.7. WebTrientine tetrahydrochloride (TETA.4HCl) for the treatment of Wilsons disease ClinicalTrials.gov Identifier: NCT03539952 Participating countries: Belgium, Brazil, Denmark, France, Germany, Italy, Poland, Sweden, UK and USA Completion date: November 2021 https://www.clinicaltrials.gov/ct2/show/NCT03539952 Clipboard, Search History, and several other advanced features are temporarily unavailable. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. FDA Approved: Yes (First approved April 28, 2022) The lesions included alveolar fibrosis, bronchiolar hyperplasia/ epithelialization of alveolar wall, focal chronic interstitial pneumonitis, bronchiolar epithelium hypertrophy, alveolar hemorrhage (males only), necrosis/regenerative hyperplasia of terminal bronchioles (males only), and acute interstitial pneumonitis (males only). Generally, mineral supplements should be avoided during TN treatment because they may block absorption. Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE): a randomised, open-label, non-inferiority, phase 3 trial - The Lancet Gastroenterology & Hepatology Articles | Volume 7, Camber Pharmaceuticals, Inc., TN chelates copper by forming a stable complex with four constituent nitrogens and is excreted mainly in the urine. This disorder causes too much copper to build up in the liver, brain, and other parts of the body. Consult your pharmacist or local waste disposal company. Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. Your doctor may have you take extra iron while you are taking trientine. Drug class: Chelating agents. Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilsons disease who are de-coppered and tolerant to penicillamine. Trientine is an effective treatment for hepatic WD even when used for initial therapy or in difficult-to-treat patients such as those with decompensated cirrhosis. You should not use this medication if you are allergic to trientine. The study performed by Weiss et al. WebThe hydrochloride salt of TETA, referred to as trientine hydrochloride, is a chelating agent that is used to bind and remove copper in the body to treat Wilson's disease, particularly in those who are intolerant to penicillamine. N'-[2-(2-aminoethylamino)ethyl]ethane-1,2-diamine;tetrahydrochloride, Treatment of Wilson's disease excluding patients intolerant to penicillamine. Business - enquiry@nuraychemicals.com Other Info - info@nuraychemicals.com. No other adverse reactions, except iron deficiency, were noted among any of these 41 patients. Take trientine on an empty stomach, at least 1 hour before or 2 hours after a meal. What Are Side Effects of Cuvrior? Sideroblastic anemia is the major side effect of therapy. Deaths related to pulmonary injury occurred in male rats at 175 and 600 mg/kg/day (1/12 and 3/20 males, respectively). Trientine is a chelating (KEE-late-ing) agent. Take this medication by mouth on an empty stomach, at least 1 hour before meals or 2 hours after meals as directed by your doctor, usually 2 to 4 times daily. Take only the amount of iron that your doctor has prescribed. Avoid concomitant use of mineral supplements (e.g. Trientine Where a direct mg to mg conversion was not possible, the total daily dosage of CUVRIOR was rounded to the nearest 150 mg of trientine base (300 mg trientine tetrahydrochloride salt) to the penicillamine total daily dosage. It not only acts as a chelating agent and promotes urinary copper excretion, but also inhibits intestinal copper absorption through metallothionein induction. Trientine is a chelating (KEE-late-ing) agent. STORAGE Although Cuprior releases more trientine in the body than the reference medicine, this difference can be addressed by lowering the dose, which is in any case adjusted according to patient response and levels of copper in the body. Trientine is used to treat this inherited condition in people who cannot take penicillamine. Trientine tetrahydrochloride Founded in 2012 by a team with vast experience across the pharmaceutical value chain, the company is on a mission to become the most preferred partner for pharmaceuticals. Chelation of excessive copper is recommended but data on the pharmacokinetics of trientine are limited. It not only acts as a chelating agent and promotes urinary copper excretion, but also inhibits intestinal copper absorption through metallothionein induction. Of the 13 patients on therapy with trientine hydrochloride (mean duration of therapy 4.1 years; range 1 to 13 years), all were alive at the data cutoff date, and in the non-treated group (mean years with no therapy 2.7 years; range 3 months to 9 years), 9 of the 12 died of hepatic disease. Its principal role is as an alternative chelator for patients intolerant of d-penicillamine. Roberts EA, Schilsky ML, Division of Gastroenterology and Nutrition, Hospital for Sick Children, Toronto, Ontario, Canada. Some recommend trientine as first-line treatment, but experience with penicillamine is more extensive. Take this medication by mouth on an empty stomach, at least 1 hour before meals or 2 hours after meals as directed by your doctor, usually 2 to 4 times daily. In general, the effects of trientine hydrochloride on urinary copper excretion are similar to those of equimolar doses of penicillamine, although in one study they were significantly smaller. It is indicated for the treatment of Wilsons disease in adults, adolescents and children five years of age or older who are intolerant to D-penicillamine therapy. Drugs. A true orphan drug trientine has proved highly effective as chronic treatment for WD. Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilsons disease who are de-coppered and tolerant to penicillamine. Conclusions: An official website of the United States government. 2020;38(2):41732. As a copper chelator, trientine when taken with meals also reduces enteric copper absorption and promotes urinary copper excretion; the usual daily dose is 5001500mg/day, in 24 divided doses. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. For patients who have difficulty swallowing the tablet whole, the scored tablet can be divided into two equal halves. Some recommend trientine as first-line treatment, but experience with penicillamine is more extensive. Following a single oral dose of 900 mg CUVRIOR, the systemic exposures (Cmax and AUCinf) were similar between males and females, although males appeared to have higher systemic exposures of trientine (approximately 30% and 50% higher for Cmax and AUCinf, respectively) following a single oral dose of 1,500 mg of CUVRIOR. The results are presented in Table 5. Home Products Trientine Tetrahydrochloride. Generic name: trientine tetrahydrochloride trientine tetrahydrochloride Indications and dose Show For trientine Show For Cufence Show For Cuprior Interactions View interactions for trientine Side-effects For trientine One investigator treated 13 patients with trientine hydrochloride following their development of intolerance to d-penicillamine. manufacturing authorisationholder responsible for batch release (annex IIA). Other mineral supplements: Administer CUVRIOR at least 1 hour before or 2 hours after administration of other mineral supplements. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. A mild iron deficiency is frequently observed as a side-effect of treatment. Pulmonary toxicity also occurred in a 13-week oral study of trientine dihydrochloride in mice. If this occurs, wash your skin with water right away. Trientine tetrahydrochloride Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE): a randomised, open-label, non-inferiority, phase 3 trial - The Lancet Gastroenterology & Hepatology Articles | Volume 7, Pfeiffenberger J, Kruse C, Mutch P, Harker A, Weiss KH. Generic name: trientine hydrochloride This site needs JavaScript to work properly. Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine This disorder causes too much copper to build up in the liver, brain, and other parts of the body. These developments highlight important problems relating to old orphan drugs for Wilson disease patients and others. For more information about treatment with Cuprior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Keep all medications away from children and pets. Compared with an identical dose of a TETA 2HCl formulation, the TETA 4HCl formulation provided more rapid absorption of trientine and greater systemic exposure in healthy subjects. Keep all medical and lab appointments. Following oral administration, the median time to reach maximum plasma concentration (Tmax) was 2.00 h (TETA 4HCl) and 3.00 h (TETA 2HCl). ScienceDirect is a registered trademark of Elsevier B.V. ScienceDirect is a registered trademark of Elsevier B.V. Rosenberg's Molecular and Genetic Basis of Neurological and Psychiatric Disease (Fifth Edition), Meyler's Side Effects of Drugs (Sixteenth Edition), Immunosuppression, rheumatic diseases, multiple sclerosis, and Wilsons disease, Drugs During Pregnancy and Lactation (Third Edition), European Association for the Study of the Liver 2012, Oral Chelator Treatment of Wilson Disease, Clinical and Translational Perspectives on WILSON DISEASE, Roberts and Schilsky, 2008; EASL, 2012; PDR, 2016, Scheinberg et al., 1987; Dubois et al., 1990; Dahlman et al., 1995; Weiss et al., 2013a, Roberts and Schilsky, 2008; EASL, 2012; Weiss et al., 2013a, Trientine for Wilson Disease: Contemporary Issues, A worldwide yearly survey of new data in adverse drug reactions, International Encyclopedia of Public Health, Chelating Agents as Therapeutic CompoundsBasic Principles, Chelation Therapy in the Treatment of Metal Intoxication, , as an alternative for the patients presenting intolerance toward D-penicillamine. Side effects of Cuvrior include: abdominal pain, change of bowel habits, rash, hair loss, and mood swings. 22-110, I.D.A., Jeedimetla, Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilsons disease who are de-coppered and tolerant to penicillamine. Dosage for Cuvrior Copyright 1996-2023 Cerner Multum, Inc. Importantly, it has gained renewed scientific attention as a possible drug intervention to treat cardiomyopathy associated with diabetes mellitus. WebTRIENTINE TETRAHYDROCHLORIDE: Official Name : English : View: View: 1,2-ETHANEDIAMINE, N,N'-BIS(2-AMINOETHYL)-, TETRAHYDROCHLORIDE: Systematic Name : English : View: View: 1,2-ETHANEDIAMINE, N1,N2-BIS(2-AMINOETHYL)-, HYDROCHLORIDE (1:4) Systematic Name : English : View: View: 1,4,7,10-TETRAAZADECANE Trientine Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. other drugs taken orally at the same time. No acute hypersensitivity reactions have been reported for TN (Roberts and Schilsky, 2008; EASL, 2012). Selected from data included with permission and copyrighted by First Databank, Inc. Chelating Properties Meyboom, in Side Effects of Drugs Annual, 2010. Trientine Cuprior is available as 150 mg tablets. We comply with the HONcode standard for trustworthy health information. Wilson disease (WD) is an autosomal recessive inherited disorder of copper metabolism.
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