offers a first-in-class portable blister pack that is room temperature stable for up to 30 days for patients with Wilson's disease who are intolerant of penicillamine.¹
Recommended dosing of CLOVIQUE1
BID, twice daily; TID, 3 times daily; QID, 4 times daily. CLOVIQUE should be taken on an empty stomach at least 1 hour before meals or 2 hours after meals, and at least 1 hour apart from any other drug, food or milk. Capsules should be swallowed whole with water and should not be opened or chewed.¹
Dosing reference chart for CLOVIQUE
CLOVIQUE carton should be kept refrigerated at 2 °C to 8 °C (36 °F-46 °F)
Capsules stored at room temperature should be discarded after 30 days
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
Treatment information for patients taking CLOVIQUE
Even if you are feeling better once you start taking your medicine, please remember to always take CLOVIQUE as prescribed by your health care professional.
Do not stop taking this medicine without speaking with your health care professional, as this may cause symptoms to return.2,3
1. Clovique. Package insert. Kadmon Pharmaceuticals, LLC; 2018.
2. Roberts EA, Schilsky ML, American Association for Study of Liver Diseases (AASLD). Diagnosis and treatment of Wilson disease: an update. Hepatology. 2008;47(6):2089-2111. doi:10.1002/hep.22261
3. Maselbas W, Chabik G, Czlonkowska A. Persistence with treatment in patients with Wilson disease. Neurol Neurochir Pol. 2010;44(3):260-263. doi:10.1016/s0028-3843(14)60040-2
important safety Information
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. CLOVIQUETM (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
CLOVIQUETM 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. CLOVIQUETM and penicillamine cannot be considered interchangeable. CLOVIQUETM should
be used when continued treatment with penicillamine is no longer
possible because of intolerable or life endangering side effects.
Unlike penicillamine, CLOVIQUETM 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.
CLOVIQUETM is not indicated for treatment of biliary cirrhosis.
Important Safety Information
CLOVIQUETM is contraindicated in patients hypersensitive to CLOVIQUETM or any components of the formulation. Patients should be observed closely for signs of possible hypersensitivity.
Patients receiving CLOVIQUETM 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).
CLOVIQUETM 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 CLOVIQUETM 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 CLOVIQUETM.
CLOVIQUETM 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.
CLOVIQUETM carton should be kept refrigerated at 2°C - 8°C (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.
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.