INDICATION
CUPRIMINE® (penicillamine) is 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 patients with severe, active rheumatoid arthritis who have not had a response to other therapy. The available evidence suggests that CUPRIMINE is not effective for the treatment of ankylosing spondylitis.
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 have cystinuria or rheumatoid arthritis and are pregnant. If you are taking CUPRIMINE to treat Wilson’s disease, continuing your treatment during pregnancy protects you against relapse of Wilson’s disease. Stopping your penicillamine treatment during pregnancy could have negative effects which could be fatal. Mothers on therapy with penicillamine should not nurse their infants. Tell your healthcare provider if you are pregnant or plan to become pregnant.
- 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 or Wilson’s disease, routine analysis of your urine may be necessary, and 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 aplastic anemia, agranulocytosis, thrombocytopenia, Goodpasture’s syndrome (an immune disease that attacks the lungs and kidneys) and myasthenia gravis (an immune disease affecting the muscles).
- Your doctor may order blood tests on a regular basis.
- CUPRIMINE can affect how your liver works. Tests to determine how your liver is working should be done regularly.
- Tell your doctor right away if you experience: blood in your urine, unexplained cough or wheezing, coughing up blood, shortness of breath, muscle weakness, drooping eyelids, double vision, watery blisters on the skin or other rash, fever, sore throat, chills, bruising, bleeding, joint pain, swollen lymph nodes, mouth ulcers, or diminished taste.
- CUPRIMINE is a drug that has many side effects, and some can be fatal. Common side effects that can occur include nausea, vomiting, and diarrhea, serious lung problems, blood problems, nervous system symptoms such as eye or ear symptoms or muscle weakness, diseases of the skin and mucous membranes, 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. Ask your doctor or pharmacist for product labeling written for professionals for a full list of potential side effects.
- Tell your doctor about all other medicines (prescription and over-the-counter, including vitamins and herbal supplements) that you are taking. Some medicines (such as gold therapy, antimalarial or cancer drugs, oxyphenbutazone or phenylbutazone) should not be used with CUPRIMINE because they also may cause serious liver, kidney, and blood side effects.
Please click here for full Prescribing Information for CUPRIMINE including Boxed Warning
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.