Prescribing Information
Important Safety Information
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Potential Side Effects Associated with CUVRIOR

Important Considerations 1
CUVRIOR should not be used if you are allergic to trientine or to any of the ingredients in CUVRIOR.

When starting CUVRIOR, your Wilson Disease symptoms could initially get worse because too much copper may be removed too quickly. Your doctor may need to reduce your dose or stop CUVRIOR treatment. Copper and iron deficiency may develop while taking CUVRIOR.

Your doctor will do tests to monitor your iron and copper levels. Allergic reactions, such as a rash can occur. If a rash or other allergic reaction occurs, stop taking CUVRIOR and get emergency medical help.

Please see additional Important Safety Information below.
CUVRIOR was safe and well tolerated in the phase III clinical trial, CHELATE1,2
Common Side Effects
The most common side effects included abdominal pain, change of bowel habits, rash, alopecia, and mood swings.
Commonality
These side effects are consistent with other trientine formulations.
It is important to talk to your healthcare provider about potential side effects of CUVRIOR.

References:

  1. CUVRIORTM (trientine tetrahydrochloride) Prescribing Information.
  2. Schilsky M L, et al. Lancet Gastroenterol Hepatol. 2022;7(12):1092-1102.

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.