Prescribing Information
Important Safety Information
For Healthcare Professionals
Talk To Your Doctor

About CUVRIOR

Before CUVRIOR, the last FDA-approved therapy for WD was nearly 30 years ago. 
About CUVRIOR
CUVRIOR Study
Safety

What is CUVRIOR?

CUVRIOR is a trientine copper chelator that works in 2 ways, eliminating absorbed copper while also reducing copper absorption in the intestine.

CUVRIOR is approved for adults with stable Wilson Disease (WD) who are de-coppered and tolerant to penicillamine. Your healthcare provider can help you decide if CUVRIOR is right for you.
How does CUVRIOR work?
CUVRIOR is a maintenance therapy that eliminates copper that is already in your body and reduces copper absorption.

CUVRIOR attaches to absorbed copper in your body so it can be eliminated through urination. It reduces new absorption by binding to copper in your intestinal tract, like from the foods you eat, so that copper can be eliminated, too.
What makes CUVRIOR different?
CUVRIOR has on-the-go potential.
  • CUVRIOR doesn't require refrigeration
  • Supplied in a portable blister pack
CUVRIOR allows for flexible dosing.
  • Tablets are scored so they can be divided in half if needed
  • Tablets are smaller than most other maintenance options
CUVRIOR offers twice-daily dosing.

CUVRIOR offers convenient twice daily dosing. You may need to cut a tablet in half to reach your prescribed dose, but it should never be crushed, chewed, or dissolved.

Take CUVRIOR on an empty stomach (at least 1 hour before meals or 2 hours after meals and at least 1 hour apart from any other food, milk, or oral medication).

See more about taking CUVRIOR.

Talk to your provider about switching to CUVRIOR

Treatment adherence can be an issue for people with WD. It's essential to work with your healthcare providers to address any treatment-related questions or concerns you may have.

Ready to talk to your provider about CUVRIOR? Everyone’s reasons for exploring a new treatment are unique. Gather your thoughts with our CUVRIOR discussion guide.

Do not use CUVRIOR if you are allergic to trientine or any of the ingredients in CUVRIOR. Your WD symptoms may worsen when starting treatment because of the rapid removal of copper from your body. Call your doctor if your symptoms worsen. Please see Important Safety Information below.

CUVRIOR Clinical Study


The CHELATE study evaluated if CUVRIOR was as effective as penicillamine (DPA) in maintaining reduced copper levels in study participants with stable WD between 18 and 75 years old.

All patients received DPA for at least 1 year before starting the study and were
adequately controlled and tolerant of DPA.

CUVRIOR maintained copper levels as well as DPA.

In this study,

  • All study participants received penicillamine for 12 weeks as part of a baseline period
  • After 12 weeks, the same study participants were randomly sorted to receive either CUVRIOR (n=26) or DPA (n=27) as part of their WD maintenance therapy
  • After 24 weeks, the effectiveness of both treatments was measured
How was the effectiveness of both drugs measured?

The end of the study compared levels of non-ceruloplasmin copper, a marker for copper levels in the blood, in all study participants.

The trial found that CUVRIOR maintained copper levels as well as DPA.

Safety

CUVRIOR is backed by the safety of trientine, a trusted WD therapy in use for over 35 years

CUVRIOR can cause serious side effects including copper and iron deficiency and allergic reactions. If a rash or other allergic reaction occurs, contact your provider immediately.

Please see Important Safety Information below.

The most common adverse events found in the CHELATE study included

  • Abdominal pain (19%)
  • Change in bowel habits (15%)
  • Rash (12%)
  • Hair loss (8%)
  • Mood swings (8%)

No serious adverse events were reported with CUVRIOR from study participants in the 24-week period.

Ready for a maintenance therapy 
you can take on the go?

CUVRIOR offers twice-daily dosing in a portable blister pack 
that doesn't require refrigeration. Learn more about taking CUVRIOR.

INDICATION

CUVRIOR is a prescription medicine used to treat adults with stable Wilson Disease who are de-coppered and able to take penicillamine. Wilson Disease is a condition where the body stores too much copper. CUVRIOR is a chelating medicine which binds copper in the blood stream and eliminates it in the urine to help reduce excess copper in the organs.

IMPORTANT SAFETY INFORMATION

  • Do not use CUVRIOR if you are allergic to trientine or to any of the ingredients in CUVRIOR.
  • Your Wilson 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 can occur. If a rash or other allergic reaction occurs, contact your doctor immediately or get emergency 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

Expand

INDICATION

CUVRIOR is a prescription medicine used to treat adults with stable Wilson Disease who are de-coppered and able to take penicillamine. Wilson Disease is a condition where the body stores too much copper. CUVRIOR is a chelating medicine which binds copper in the blood stream and eliminates it in the urine to help reduce excess copper in the organs.

IMPORTANT SAFETY INFORMATION

  • Do not use CUVRIOR if you are allergic to trientine or to any of the ingredients in CUVRIOR.
  • Your Wilson 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 can occur. If a rash or other allergic reaction occurs, contact your doctor immediately or get emergency 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.