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 worldwide prevalence of Wilson's disease is estimated to be one in 30,000 individuals.2 The gold standard for diagnosis of Wilson’s disease is liver biopsy, although other tests can be a useful guide.3

The condition is effectively treated with a low copper diet and chelating agents that bind copper to facilitate its excretion from the body. Cuprimine® (Penicillamine) is a first-line chelating agent recommended for removal of excess copper in patients with Wilson’s disease.4

Cuprimine is also indicated in the treatment of cystinuria and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.4

Indication

Cuprimine® (Penicillamine) Capsules are used to treat Wilson's disease (a disease where there is too much copper in the body), cystinuria (a disease where an excess amount of certain proteins are in the urine) and in patients with severe, active rheumatoid arthritis who have not had a response to other therapy.

Important Safety Information

WARNING: You should be under the close supervision of your doctor when you are taking Cuprimine. Report any side effects promptly to your doctor.

  • Do not take Cuprimine if you are pregnant or a nursing mother, unless you are taking Cuprimine to treat Wilson’s disease or cystinuria.

  • Cuprimine can cause serious blood disorders, and some can be fatal. If you have had aplastic anemia (anemia due to lack of all blood cells) or agranulocytosis (lack of certain white blood cells) and it was related to taking Cuprimine, you should not take it again.

  • Cuprimine can cause kidney damage and should not be used to treat rheumatoid arthritis if you have a history of kidney disease. If you take Cuprimine to treat cystinuria, you should have an x-ray every year to check for kidney stones.

  • Cuprimine can be associated with fatalities due to other diseases such as Goodpasture’s syndrome (an immune disease that attacks the lungs and kidneys) and myasthenia gravis (an immune disease affecting the muscles).

  • Cuprimine can affect how your liver works. Tests to determine how your liver is working should be done regularly.

  • Cuprimine is a drug that has a high rate of side effects, and some can be fatal. Other side effects that can occur include serious lung problems, nervous system symptoms, diseases of the skin and mucous membranes known as pemphigus, allergic reactions (including a condition known as drug fever as well as skin rashes), mouth ulcers, and loss of taste. Talk to your doctor if you experience side effects and also about possible side effects that could occur.

  • Tell your doctor about all other medicines that you are taking. Some medicines should not be used with Cuprimine because they also may cause serious liver and kidney side effects.

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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.

References: 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. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Wilson’s Disease. J Hepatol. 2012;56:671-685. 3. 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. 4. Cuprimine package insert. Lawrenceville, NJ: Aton Pharma; 2010.