Consult your doctor or pharmacist for more details. You can findproduct informationdocuments for centrally authorised human medicines on this website. Neurological and/or musculoskeletal clinical signs (abnormal stiff-legged gait, limited use of limb, underactivity, body tremors) occurred in a 26-week oral toxicity study of trientine dihydrochloride in dogs at 5.5 times the estimated human exposure at the maximum recommended dose (based on AUC). It not only acts as a chelating agent and promotes urinary copper excretion, but also inhibits intestinal copper absorption through metallothionein induction. The capsules should be swallowed whole with water (never opened or divided) (PDR, 2016). Treatment for: Wilson's Disease. It is not intended to provide practical advice on how to use Cuprior. 2018;4(1):21. The https:// ensures that you are connecting to the iron. Dosage form: capsule 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 1250 mg/day for adults given in divided doses two, three or four times daily. A randomised single-centre crossover study to evaluate the pharmacokinetics, safety and tolerability of two different oral formulations of trientine (TETA 4HCl tablets vs TETA 2HCl capsules) in 23 healthy adult subjects receiving a single dose equivalent to 600 mg of trientine base was performed. A chelating agent works by removing a heavy metal (such as lead, mercury, or copper) from the blood. Overview This is a summary of the European public assessment report (EPAR) for Cuprior. Controversial data are available on the copper-chelating potency of DPA and TN. Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine. Advise patients that if they have difficulty swallowing the tablet whole, the scored tablet can be divided into two equal halves. Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's. other drugs taken orally at the same time. Talk to your pharmacist for more details. It was originally designated an orphan medicine on 19 March 2015. Cuprior contains the active substance trientine. Ask your doctor before using a vitamin or mineral supplement, and use only the type your doctor recommends. 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). Medically reviewed by Drugs.com on Dec 5, 2022. Other adverse effects include dyspepsia, muscle spasms, and dystonia. Joshua P. Gray, Sidhartha D. Ray, in Side Effects of Drugs Annual, 2014. In the 13 patients treated with trientine hydrochloride, previous symptoms and signs relating to d-penicillamine intolerance disappeared in 8 patients, improved in 4 patients, and remained unchanged in one patient. Trientine is used to treat this inherited condition in people who cannot take penicillamine. Trientine is an effective treatment for Wilsons disease. Nat Rev Dis Primers. We use cookies to help provide and enhance our service and tailor content and ads. Drug class: Chelating agents. Avoid concomitant use of mineral supplements (e.g. Do not drink milk, eat food, or take any other medications for at least 1 hour after you take trientine. In a retrospective study in five patients, trientine 5001000mg/day as a single dose was effective in controlling Wilsons disease (48c). This is not a complete list of possible side effects. Chelation treatment with trien can induce zinc depletion when the ligand is in excess with respect to the amount required to chelate the target copper metal ion. Before taking trientine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Sideroblastic anemia caused by copper deficiency is the major side effect of therapy. 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]. Side effects of Cuvrior include: abdominal pain, change of bowel habits, rash, hair loss, and mood swings. Unauthorized use of these marks is strictly prohibited. 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. Brand names: Syprine, Clovique, Cuvrior 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). In the case of appropriate chelating treatment, daily urinary copper excretion should be in the normal range (Roberts and Schilsky, 2008; EASL, 2012). Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. WebChelation of excessive copper is recommended but data on the pharmacokinetics of trientine are limited. The structural formula is: Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Visit the FDA MedWatch website or call 1-800-FDA-1088. Most of the few but serious side effects of penicillamine, including nephritis and arthritis, subside with trientine therapy (Dahlman etal., 1995). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. STORAGE If you notice other effects not listed above, contact your doctor or pharmacist. These developments highlight important problems relating to old orphan drugs for Wilson disease patients and others. 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. Zinc (usually zinc acetate dehydrate 75150mg/day in three divided doses) inhibits the enteric absorption of copper by stimulating intestinal and hepatic metallothioneins. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Trientine is used to treat this inherited condition in people who cannot take penicillamine. 2022 Sep 14;15(9):1145. doi: 10.3390/ph15091145. 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). The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. Trientine tetrahydrochloride (brand name Cuprior) wasapproved for medical use in the European Union in September 2017. Importantly, TN chelates iron, making toxic complexes; therefore, iron should not be added to therapy with TN. 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 two to four divided doses. Do not open or chew the capsules. Woimant F, Debray D, Morvan E, Obadia MA, Poujois A. J Clin Med. 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. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Mulligan C, Bronstein JM. 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, If your doctor directs you to also take an iron supplement, take it at least 2 hours before or after trientine. See additional information. Package insert / product label Advise patients not to store the tablet for future use after the blister has been opened. 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. Therapy with TN results in ADRs less frequently than DPA (Roberts and Schilsky, 2008; EASL, 2012; Weiss et al., 2013a). Corinna Weber-Schndorfer, in Drugs During Pregnancy and Lactation (Third Edition), 2015. Larger prospective trials are needed to confirm the efficacy of once-daily trientine and to determine the required dose. In addition, the TN product is unstable and should be stored tightly closed at 28C (EASL, 2012). Your condition will not improve any faster, and your risk of side effects will increase. The high positive charge of trien, from +2 to +3 in the gut pH range 67.4 (Nugent etal.,2001), explains its poor intestinal absorption according to Lipinski criteria (Lipinski etal.,1997). Careers. Immediately after TN is introduced, urinary copper excretion should increase more than 1000g/24 hours and during chronic WD treatment (after 1 year) should be approximately 300500g/24 hours. For further information, see the package leaflet. In contrast to DPA, TN is not recommended in cystinuria (absence of sulfhydryl groups) and rheumatoid arthritis. The dosage was permitted to be adjusted depending on clinical response. Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. Remove CUVRIOR tablets from the blister pack only at the time of dosing. Wilson's disease is a genetic metabolic defect that causes excess copper to build up in the body. Do not take trientine in larger or smaller amounts or for longer than recommended. The mean age at onset of disease of the latter group was 12 years as compared to 21 years for the former group. Trientine, like d-penicillamine, promotes urinary copper excretion. HETERO TM Select a condition to view a list of medication options. Cuprior can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease. What Are the Best PsA Treatments for You? Conclusions: 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. official website and that any information you provide is encrypted Usual Pediatric Dose for Wilson's Disease: 13 and older:750 to 1250 mg, orally, in divided doses given 2, 3, or 4 times dailyMaximum dose: 2000 mg daily12 and under:500 to 750 mg, orally, in divided doses given 2, 3, or 4 times dailyMaximum dose: 1500 mg dailyComments:-Increase dose for inadequate clinical response or free serum copper persistently above 20 mcg/dL.-Re-evaluate dose every 6 to 12 months.-Clinical experience with this drug is limited and alternate dosing regimens have not been well characterized.-All dosing endpoints are not well defined.-This drug is not interchangeable with penicillamine.-Use this drug when penicillamine treatment is not possible because of intolerable or life threatening side effects.-This drug is not recommended for cystinuria or rheumatoid arthritis.-It is incapable of binding cystine, so it is of no use in cystinuria.-In a small study, it was ineffective for rheumatoid arthritis.-This drug is not indicated for treatment of biliary cirrhosis.Use: Treatment of Wilson's disease in patients who are intolerant of penicillamine. Clinical experience with trientine hydrochloride has been limited. 750 to 1250 mg, orally, in divided doses given 2, 3, or 4 times dailyMaximum dose: 2000 mg dailyComments:-Increase dose for inadequate clinical response or free serum copper persistently above 20 mcg/dL.-Re-evaluate dose every 6 to 12 months.-Clinical experience with this drug is limited and alternate dosing regimens have not been well characterized.-All dosing endpoints are not well defined.-This drug is not interchangeable with penicillamine.-Use this drug when penicillamine treatment is not possible because of intolerable or life threatening side effects.-This drug is not recommended for cystinuria or rheumatoid arthritis.-It is incapable of binding cystine, so it is of no use in cystinuria.-In a small study, it was ineffective for rheumatoid arthritis.-This drug is not indicated for treatment of biliary cirrhosis.Use: Treatment of Wilson's disease in patients who are intolerant of penicillamine. There is a report of an adult woman who ingested 30 grams of trientine hydrochloride without apparent ill effects. The mean NCC level at Week 36 as measured using an assay not commercially available was similar in patients receiving CUVRIOR and in patients receiving penicillamine. Overview This is a summary of the European public assessment report (EPAR) for Cuprior. Issued: 07/2022, Trientine Hydrochloride Capsules USP 250 mg- Container Carton Label, Trientine Hydrochloride Capsules USP 250 mg- Container Label. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under. Currently, in countries where available (limited), TN is usually used in patients with ADRs during DPA treatment, as the negative effects of DPA mostly resolve with TN and do not recur (EASL, 2012). Studies in animals have shown that trientine hydrochloride has cupriuretic activities in both normal and copper-loaded rats. Generally, mineral supplements should be avoided during TN treatment because they may block absorption. To take account of this difference, Cuprior is used at lower doses. Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition. https://doi.org/10.1038/s41572-018-0018-3, https://doi.org/10.1016/j.ncl.2020.01.005, https://doi.org/10.1016/S0140-6736(07)60196-2, Industry Sponsored Study/Orphalan, France. You may notice worsening in certain symptoms of Wilson's disease (such as problems with speech/swallowing/coordination, uncontrolled movements) when you start taking trientine as the medication begins to work to reduce the copper levels in your body. Dosage form: oral capsule (250 mg) (1997) (about 10% of the orally administered trien can be found in urines, 1% as trien and 8% as acetyltrien) and with the more recent results of Lu etal.(2007), who found urinary recovery between 0.03 and 13.4% in healthy volunteers and between 3.7 and 14.6% in diabetic patients. Trientine is an effective treatment for Wilsons disease. Side effects of Cuvrior include: abdominal pain, change of bowel habits, rash, hair loss, and mood swings. 2023 Feb;38(2):219-224. doi: 10.1111/jgh.16050. Take the missed dose as soon as you remember. PDF | On Nov 29, 2019, Rupert Purchase published Trientine tetrahydrochloride (Cuprior) | Find, read and cite all the research you need on ResearchGate Cuprior was withdrawn from the Community register of orphan medicinal products by the European Commission in July 2017, at the time of the granting of a marketing authorisation. Last updated on Aug 1, 2022. Do not chew, break, or open a trientine capsule. Common adverse reactions include abdominal pain, change of bowel habits, rash, alopecia, and mood swings. Trientine hydrochloride was teratogenic in rats at doses similar to the human dose. 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 Importantly, it has gained renewed scientific attention as a possible drug intervention to treat cardiomyopathy associated with diabetes mellitus. Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. Drugs. Trientine tetrahydrochloride if approved has the potential to be used as maintenance therapy in patients with Wilsons Disease. Wilson's disease is a genetic metabolic defect that causes excess copper to build up in the body. 17/08/2022 Cuprior - EMEA/H/C/004005 - R/0018. Dosage for Cuvrior Treatment cessation for 2 days has also been suggested. Trientine was discontinued and zinc was started to prevent copper absorption. Clinical Summary 2011 Jul 9;71(10):1281-320. doi: 10.2165/11591370-000000000-00000. Other drugs may interact with trientine, including prescription and over-the-counter medicines, vitamins, and herbal products. MeSH Trien forms chelates also with other essential metal ions as ZnII (Nurchi etal.,2013) and FeII (Sacconi etal.,1961), even if the stabilities of complexes with these essential metal ions are much lower than that with CuII. Trientine (triethylene tetramine dihydrochloride or trien) was introduced in 1969. Tell your doctor right away if you have symptoms such as feeling very tired, weakness, pale skin, chest pain, fast heartbeat, shortness of breath, cold hands/feet. WebThis medication is used to treat a certain inherited disorder ( Wilson's disease ). Do not remove tablets from the blister pack until just before dosing. Trientine tetrahydrochloride (brand name Cuprior) was. 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, Swallow tablets of CUVRIOR without crushing, chewing, or dissolving tablets. Different brands of this medication have different storage needs. Compared to d-penicillamine, trientine is remarkably free of adverse effects, although neurological worsening may occur infrequently. Available for Android and iOS devices. 2020;71(2):72232. WebTrientine. 22-110, I.D.A., Jeedimetla, A practice guideline on Wilson disease. WebChelation of excessive copper is recommended but data on the pharmacokinetics of trientine are limited. Written by Cerner Multum. 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. Six-hour excretion rates of copper were determined off treatment and after a single dose of 500 mg of penicillamine or 1.2 g of trientine hydrochloride. Therapy with trientine hydrochloride was discontinued. PMC Role of Trientine in Hypertrophic Cardiomyopathy: A Review of Mechanistic Aspects. Always tell your doctor right away about these symptoms. 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. Changes since initial authorisation of medicine, Initial marketing-authorisation documents, Committee for Medicinal Products for Human Use, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017, Send a question to the European Medicines Agency, International non-proprietary name (INN) or common name, Anatomical therapeutic chemical (ATC) code, Date of issue of marketing authorisation valid throughout the European Union. Take your next dose at the regular time. 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. 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. Data sources include IBM Watson Micromedex (updated 3 July 2023), Cerner Multum (updated 10 July 2023), ASHP (updated 10 July 2023) and others. It is a white to pale yellow crystalline powder. Nevertheless, there are no head-to-head studies comparing TN and DPA as well as ZS, and all data on the superiority of a treatment should be discussed with caution.
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