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.1
The worldwide prevalence
of WD is estimated to be one in 30,000 individuals.2
The condition can be treated with a low copper diet and the use of chelating agents that bind copper to facilitate its excretion from the body. CLOVIQUE™ (trientine hydrochloride) is a chelating agent indicated for treatment of patients
with WD who are intolerant of the first-line treatment, penicillamine.3
Indications and Usage
CLOVIQUE™ may be used to treat Wilson's disease in patients who cannot take the medication penicillamine. Clinical experience with trientine hydrochloride 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. CLOVIQUE™ and penicillamine cannot be considered interchangeable. CLOVIQUE™ should be used when continued treatment with penicillamine is no longer
possible because of intolerable or life endangering side effects.
Unlike penicillamine, CLOVIQUE™ 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 was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
CLOVIQUE™ is not indicated for treatment of biliary cirrhosis.
Important Safety Information
- CLOVIQUE™ is contraindicated in patients hypersensitive to CLOVIQUE™ or any components of the formulation. Patients should be observed closely for signs of possible hypersensitivity.
- Patients receiving CLOVIQUE™ 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).
- CLOVIQUE™ contains a color additive FD&C Yellow #5 (tartrazine) that may cause allergic-type reactions (including bronchial asthma) in certain people. It is frequently seen in patients who also have aspirin hypersensitivity.
- Patients should be directed to take CLOVIQUE™ 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 CLOVIQUE™.
- CLOVIQUE™ 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 using trientine hydrochloride: iron deficiency, systemic lupus erythematosus. In addition, dystonia, muscular spasm, myasthenia gravis have been reported in marketed use.
- CLOVIQUE™ carton should be kept refrigerated at 2-°8C (36°F - 46°F).
- For patient convenience, individual blister pack (or tray) may be stored for a maximum single period of 30 days at or below room temperature (25°C (77°F)) with protection from sources of heat and humidity. Capsules stored
at room temperature should be discarded after 30 days.
Please see full Prescribing Information for CLOVIQUE™ Capsules.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC at 1-877-377-7862 to report negative side effects.
- Gaffney D, Fell GS, O'Reilly DS. ACP Best Practice No 163. Wilson's disease: acute and
presymptomatic laboratory diagnosis and monitoring. J Clin Pathol. 2000;53(11):807-812.
- European Association for Study of Liver. EASL Clinical Practice Guidelines: Wilson's Disease. J Hepatol. 2012;56(3):671-685.
- Clovique™ Package Insert. Kadmon Pharmaceuticals, LLC 2018.
- Roberts EA, Schilsky ML, Diagnosis and Treatment of Wilson Disease: An Update, Hepatology, June 2008: 2089 – 2111
- Maselbas W, Chabik G, Czlonkowska A, Persistence with treatment in patients with Wilson disease, Neurologia i Neurochirurgia Polska 2010; 44, 3: 260 - 263).
©2018 Kadmon Pharmaceuticals, Inc.