Introduction

Wilson's disease, 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 prevalence of Wilson's disease in the general population is 1 per 40,000. The gold standard for diagnosis of Wilson's disease is liver biopsy, although other tests can be a useful guide.2

The condition is effectively treated with a low copper diet and chelating agents that bind copper to facilitate its excretion from the body. Syprine® is a chelating agent indicated for treatment of patients with Wilson's disease who are intolerant of the first-line treatment, penicillamine. 3

Indications and Usage

SYPRINE® is used to treat Wilson's disease in patients who cannot take the medication known as penicillamine. Wilson’s disease is a condition where the body stores too much copper. SYPRINE® is not recommended to treat cystinuria (a condition where a protein known as cystine is excreted into the urine), rheumatoid arthritis, or a disease affecting the bile ducts in the liver known as biliary cirrhosis.

Important Safety Information

Do not take SYPRINE® if you are allergic to it or any parts of the formulation.

You should remain under regular medical supervision the entire time you are taking SYPRINE®. Your doctor should regularly check to see if you have iron deficiency anemia. This is particularly important for women.

Take SYPRINE® on an empty stomach, at least one hour before a meal or two hours after a meal 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, take your temperature every night, and report any symptom such as fever or skin rash to your doctor.

The following adverse reactions have been reported from a clinical study: iron deficiency and a condition affecting the immune system known as systemic lupus erythematosus. In addition, the following adverse reactions have been reported in marketed use: abnormal or uncontrolled muscle contractions, muscle spasm and an immune disease affecting muscles known as myasthenia gravis.

Do not take mineral supplements because they may block the absorption of SYPRINE®.

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You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Reference: 1. Gaffney D, Fell GS, O'Reilly St. J. Wilson's disease: acute and presymptomatic laboratory diagnosis and monitoring. J Clin Pathol. 2000;53:807-12. 2. Brewer GJ. Wilson's disease. In: Kasper DL, Fauci AS, Longo DL, eds. Harrison's Principles of Internal Medicine. New York. 16th ed. McGraw-Hill. 2005:2313-15. 3. http://www.syprine.com/pdfs/Syprine_PI.pdf; Syprine package insert. Lawrenceville, NJ Aton Pharma; 2007.

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