Whether you have already started taking CLOVIQUE (Trientine Hydrochloride Capsules, USP), or are considering it, you may have questions.

Listed below are some answers to frequently asked questions (FAQs). Please remember to always discuss your treatment options with your doctor.

  • Q: What is CLOVIQUE?

    A: CLOVIQUE is a trientine hydrochloride–based therapy for the management of Wilson's disease in patients who cannot take the medicine penicillamine (eg, Cuprimine®).

  • Q: How is CLOVIQUE different from other trientine products?

    A: CLOVIQUE offers unique advantages for patients and caregivers in the way that it is packaged. While the CLOVIQUE carton should be kept refrigerated at 2 °C to 8 °C (36 °F-46 °F), each individual blister pack can be stored at room temperature for up to 30 days. CLOVIQUE individual blister packs also feature easy pill tracking, which can help you keep track of the capsules you have already taken and the ones you still need to take. In addition, each carton of CLOVIQUE contains 120 capsules, compared with bottled trientine products that only include 100 capsules.

  • Q: How does CLOVIQUE work?

    A: CLOVIQUE is a chelating compound for removal of excess copper from the body.

  • Q: How do I take CLOVIQUE?

    A: Take CLOVIQUE as prescribed by your doctor. In addition, it is important to take CLOVIQUE on an empty stomach at least 1 hour before a meal, or 2 hours after a meal, and at least 1 hour apart from any other drug, food or milk. The capsules should be swallowed with water and should not be opened or chewed. For the first month of treatment, take your temperature every night. Report any symptoms, such as fever or skin rash, to your doctor.

  • Q: How is CLOVIQUE dosed?

    A: Clinical experience with CLOVIQUE is limited, and alternative dosing regimens have not been well characterized. There are a wide variety of dosing options, and only your doctor can customize your treatment plan.

  • Q: How should I store CLOVIQUE?

    A: CLOVIQUE cartons should be kept refrigerated at 2 °C to 8 °C (36 °F-46 °F). For patient convenience, individual blister packs may be stored for a maximum single period of 30 days at room temperature (25 °C [77 °F]) with protection from sources of heat and humidity. Capsules stored at room temperature must be discarded after 30 days.

  • Q: What does room-temperature stable mean? Do I need to keep CLOVIQUE in the refrigerator?

    A: Room-temperature stable means you may store CLOVIQUE outside of the refrigerator. Individual blister packs may be stored for a maximum single period of 30 days at room temperature (25 °C [77 °F]) with protection from sources of heat and humidity, allowing you to take this medicine with you on sleepovers, camping trips, road trips and vacations. Capsules stored at room temperature must be discarded after 30 days.

  • Q: Is CLOVIQUE the right treatment option for me?

    A: CLOVIQUE is indicated for the treatment of Wilson's disease in patients who cannot take the medicine penicillamine. Talk with your doctor about which treatment option is right for you.

  • Q: What are the most common side effects of CLOVIQUE?

    A: Side effects are likely to be the same as with Syprine®, including iron deficiency, a condition affecting the immune system known as systemic lupus erythematosus, abnormal or uncontrolled muscle contractions, muscle spasm and an immune disease affecting muscles known as myasthenia gravis.

  • Q: If I feel better, does that mean I can stop taking CLOVIQUE?

    A: It is important that you take CLOVIQUE as prescribed. Do not stop taking this medicine without first talking with your doctor.

  • Q: Should I take CLOVIQUE with food?

    A: It is important that CLOVIQUE 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. The capsules should be swallowed with water and should not be opened or chewed.

  • Q: Is it okay to take vitamins while taking CLOVIQUE?

    A: In general, mineral supplements should not be taken because they may block the absorption of CLOVIQUE; however, most common vitamins (A, B6, C, D and E) may be taken as needed. Iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low-copper diet recommended for Wilson’s disease. If necessary, iron may be given in short courses; however, since iron and CLOVIQUE each inhibit absorption of the other, 2 hours should elapse between administration of CLOVIQUE and iron.

  • Q: Will my insurance cover CLOVIQUE?

    A: Your insurance may or may not cover CLOVIQUE. However, you could be eligible for CLOVIQUEConnect, a copay card program that may offer patients access to treatment. Eligible patients may pay as little as $0 per month for CLOVIQUE.*

  • Q: Is there a copay program for CLOVIQUE?

    A: Yes, CLOVIQUEConnect is a copay card program that may offer patients access to treatment. Eligible patients may pay as little as $0 per month for CLOVIQUE.*

  • Q: Can I take CLOVIQUE if I am or may be pregnant?

    A: Trientine hydrochloride was demonstrated to cause birth defects in rats at doses similar to the human dose. There are no adequate and well-controlled studies in pregnant women. If you are prescribed CLOVIQUE and think that you are or might become pregnant, speak with your doctor to determine your options.


 

Additional FAQs for Patients Switching to CLOVIQUE

  • Q: I am already prescribed trientine hydrochloride. Should I switch to CLOVIQUE? How do I switch?

    A: Each individual CLOVIQUE capsule contains trientine hydrochloride 250 mg, identical to other trientine-containing products. CLOVIQUE may be a more convenient option for patients and caregivers because individual blister packs can be stored at room temperature for up to 30 days. If you are interested in switching to CLOVIQUE, speak with your doctor or pharmacist.

  • Q: My doctor advised me to switch to CLOVIQUE because of my intolerance to penicillamine. What are the differences between these 2 therapies?

    A: CLOVIQUE and penicillamine are both chelating agents; however, they 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. The chart below outlines the major differences between the 2 therapies.

     
    Drug Mode of action Adverse effects Dose Monitoring adequacy
    Penicillamine1 Chelates copper and induces copper excretion Early: fever, rash, lymphadenopathy, cytopenias, proteinuria
    Late: nephrotoxicity, lupus-like syndrome, goodpasture syndrome, bone marrow toxicity, dermatologic toxicity (elastosis perforans serpiginosa)
    Very late: nephrotoxicity, myasthenia gravis, polymyositis
    Initial: Adult: 750 to 1500 mg BID to QID Children: 20 mg/kg/d BID to QID Maintenance: 15 mg/kg/d 24-hour urinary copper Nonceruloplasmin bound copper
    Trientine1 Chelates copper and induces copper excretion Gastritis, aplastic anemia, sideroblastic anemia Initial: Adult: 750 to 1500 mg BID to QID Children: 20 mg/kg/d BID to QID Maintenance: 15 mg/kg/d 24-hour urinary copper Nonceruloplasmin bound copper
    BID, twice daily; QID, four times daily.
    1. 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
  • Q: How is CLOVIQUE different from the trientine I have been prescribed before?

    A: CLOVIQUE packaging offers a unique advantage for patients over all other currently available bottled trientine products. Each individual blister pack can be stored at room temperature for up to 30 days. CLOVIQUE individual blister packs also feature easy pill tracking, so you can monitor your daily dose. In addition, each carton of CLOVIQUE contains 120 capsules, compared with bottled trientine that only includes 100 capsules.

  • Q: Is CLOVIQUE the same as other trientine hydrochloride–containing products?

    A: CLOVIQUE capsules have been shown to be bioequivalent to Syprine® in a clinical study. This means CLOVIQUE capsules have been shown to have the same safety and efficacy. However, CLOVIQUE is the only trientine hydrochloride product that is available in a room temperature stable blister pack.

  • Q: Are there adverse reactions that occur when switching from trientine to CLOVIQUE?

    A: Given that CLOVIQUE is the same as other trientine hydrocholride–containing products, we do not expect new or different adverse reactions when switching to CLOVIQUE. Should you experience a new adverse reaction, contact your doctor. To report SUSPECTED ADVERSE REACTIONS, contact Kadmon Pharmaceuticals, LLC at 1-877-377-7862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA, US Food and Drug Administration.
*Eligibility restrictions apply. Offer is not valid under Medicare, Medicaid or any other federal or state programs.  

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.

Please see full Prescribing Information for CLOVIQUETM 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.

References:
  1. 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.

  2. European Association for Study of Liver. EASL clinical practice guidelines: Wilson's disease. J Hepatol. 2012;56(3):671-685.

  3. Clovique. Package Insert. Kadmon Pharmaceuticals, LLC; 2018.

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