Prescribing Information
Important Safety Information
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Dosing and Administration

Total
Daily Dosage

The starting total daily dosage of CUVRIOR in adults is 300 mg up to 3,000 mg orally in divided doses (2 times daily). 1

  • Total daily dosage of CUVRIOR should not exceed 3,000 mg 1
  • Administer 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 milk 1
  • CUVRIOR tablets are scored and can be divided in half, allowing fractional dosing and easy swallowing 1
Switching from D-penicillamine (DPA)
Discontinue DPA before starting CUVRIOR. 1

The table below provides the recommended starting total daily dosage of CUVRIOR in adult patients switching from DPA to CUVRIOR. 1
Recomended Starting Total Daily Dosage of CUVRIOR when Switching from Penicillamine to CUVRIOR
Penicillamine Total Daily Dosage CUVRIOR Starting Daily Dosage
125 mg 300 mg
250 mg 600 mg
375 mg 900 mg
500 mg 900 mg
625 mg 1,200 mg
750 mg 1,500 mg
875 mg 1,800 mg
1,000 mg 2,100 mg
1,125 mg 2,400 mg
1,250 mg 2,400 mg
1,375 mg 2,700 mg
1,500 mg or greater 3,000 mg
Figure adapted from CUVRIOR Prescribing Information 1
Switching from Other Trientine Products
CUVRIOR is not substitutable on a milligram-per-milligram basis with other trientine products. 1

If switching a patient from a trientine hydrochloride formulation to CUVRIOR, note that the content of the active moiety (trientine base) is not the same as CUVRIOR. A 250 mg capsule of trientine hydrochloride contains 167 mg of trientine base; in contrast, each 300 mg tablet of CUVRIOR contains 150 mg of trientine base. 1

References:

  1. CUVRIORTM (trientine tetrahydrochloride) Prescribing Information.

Indication & Important Safety Information

CUVRIOR is a copper chelator indicated for the treatment of adult patients with stable Wilson Disease who are de-coppered and tolerant to penicillamine. Please see full Prescribing Information.
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

CONTRAINDICATIONS

  • CUVRIOR is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in CUVRIOR.

WARNINGS AND PRECAUTIONS

  • Potential for Worsening of Clinical Symptoms at Initiation of Therapy, including neurological deterioration, may occur at the beginning of CUVRIOR therapy due to mobilization of excess stores of copper. Adjust the dosage or discontinue therapy if clinical condition worsens. Evaluate serum non-ceruloplasmin copper (NCC) levels or 24-hour urinary copper excretion (UCE) when initiating treatment, after 3 months, and approximately every 6 months thereafter.
  • Copper Deficiency may develop following treatment with CUVRIOR. Periodic monitoring is required.
  • Iron Deficiency may develop following treatment with CUVRIOR. If iron deficiency develops, a short course of iron supplementation may be given.
  • Hypersensitivity Reactions, characterized by rash, have been reported with the use of trientine. Rash was reported in 12% (3/26) of CUVRIOR-treated patients, and one patient discontinued treatment due to rash. If rash or other hypersensitivity reaction occurs, consider discontinuing CUVRIOR.

ADVERSE REACTIONS

The most common adverse reactions (>5%) are abdominal pain, change of bowel habits, rash, alopecia, and mood swings.

DRUG INTERACTIONS

  • Mineral Supplements (e.g. iron, zinc, calcium, magnesium): Avoid concomitant use. If concomitant use is unavoidable, take CUVRIOR at least 2 hours before or 2 hours after iron and take CUVRIOR at least 1 hour before or 2 hours after other mineral supplements.
  • Other Drugs for Oral Administration: Take CUVRIOR at least 1 hour apart from any other oral drug

Please see full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, call Orphalan at 1-800-961-8320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch