Prescribing Information
Important Safety Information
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How is CUVRIOR Dosed?

Your healthcare provider will tell you your daily dose of CUVRIOR
Your daily dose of CUVRIOR may change depending on how well the treatment is working (your physician will base this on clinical assessments and the monitoring of copper levels in your body): 1

The starting total daily dose of CUVRIOR in adults is 300 mg up to 3,000 mg divided into two daily doses.

Step 1

Total daily dose of CUVRIOR should not exceed 3,000 mg.

Step 1

If you are switching from a trientine hydrochloride formulation to CUVRIOR, note that the content of trientine is not the same as CUVRIOR.

Step 1

You should 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 or meals.

Step 1

CUVRIOR tablets are scored and can be divided in half, allowing dose adjustment and easy swallowing.

Step 1

The tablets should not be removed from the blister pack until the time of dosing, to ensure that they are not damaged in any way and prevent underdosing.

Step 1

Take CUVRIOR at least 1 hour apart from any other oral medicine. 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.

See the Important Safety Information below.

Step 1

CUVRIOR should be stored at a controlled room temperature of 20oC to 25oC, but brief spells at between 15oC and 30oC are permitted. 1

References:

  1. CUVRIORTM (trientine tetrahydrochloride) Prescribing Information.

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.