Prescribing Information
Important Safety Information
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About Orphalan

At Orphalan we identify, develop, and provide access to innovative treatments for patients with rare diseases to make a positive and meaningful difference. We work together by listening to patients and putting them first, enabling us to provide treatments and services that work for them.

We use a global network of experts including scientists, academic institutions and companies with innovative technologies to provide support to patients.
At Orphalan we offer the following approach:
  • Putting patients at the core of everything we do
  • A primary focus on rare, often fatal diseases where current therapeutic options do not exist, are suboptimal, or are associated with severe complications
  • Evidence based treatments: All our treatments are backed by data driven generation of scientific evidence.
  • Successful commercial and regulatory implementation of treatments across multiple markets
At Orphalan we continuously invest in research and development, actively exploring novel drug options to treat a range of devastating rare diseases.

Our goal is for patients to receive the best treatment possible by developing comprehensive research and development programs, delivering educational programs to patients and physicians.
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Indication & Important Safety Information

CUVRIOR is a prescription medicine for the treatment of adult patients with stable Wilson Disease who are de-coppered and able to take penicillamine. CUVRIOR is a chelating medicine which binds copper, helping your organs release copper into your bloodstream which is then removed through your urine.
Important Safety Information
INDICATION
CUVRIOR is a copper chelator indicated for the treatment of adult patients with stable Wilson Disease who are de-coppered and tolerant to penicillamine.
IMPORTANT SAFETY INFORMATION
  • Do not use CUVRIOR if you are allergic to trientine or to any of the ingredients in CUVRIOR.
  • Your Wilson’s Disease symptoms could get worse when you start treatment. This could happen because too much copper is removed from the body in a short period of time. Your doctor may need to reduce your dose or stop CUVRIOR treatment.
  • Copper deficiency may develop following treatment with CUVRIOR. Your doctor will do tests to monitor your urine and blood for copper.
  • Iron deficiency may develop while taking CUVRIOR. If this happens, your doctor may tell you to take iron supplements for a limited time.
  • Allergic reactions, such as a rash, have been reported with trientine, the active ingredient in CUVRIOR. If a rash or other allergic reaction occurs, stop taking CUVRIOR and get emergency medical help.
  • The most common side effects are pain in the abdomen, change in bowel habits, rash, hair loss (alopecia), and mood swings.

Take CUVRIOR at least 1 hour apart from any other oral medicine. Tell your doctor about all the medicines you're taking, including over-the-counter medicines, vitamins, and herbal supplements. Avoid taking supplements when taking CUVRIOR. Taking CUVRIOR with mineral supplements (e.g., iron, zinc, calcium, magnesium) can reduce the effectiveness of CUVRIOR. If iron supplementation is necessary, take CUVRIOR at least 2 hours before or 2 hours after taking iron; for other mineral supplements (e.g., zinc, calcium, magnesium), take CUVRIOR at least 1 hour before or 2 hours after. Do not start or stop any medicines while taking CUVRIOR without talking to your doctor.

These are not all the possible side effects of CUVRIOR. You are encouraged to report negative side effects of prescription drugs. Contact Orphalan at 1-800-961-8320 or AdverseEventReporting@orphalan.com or FDA at 1-800-FDA-1088 or www.fda.gov/​medwatch.

Please see full Prescribing Information.