Prescribing Information
Important Safety Information
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CUVRIOR Safety

CHELATE Trial Safety Results 1
Safety was assessed in the first trientine head-to-head prospective, randomized, phase III CHELATE trial

PATIENTS

Aged 18-75 with stable Wilson Disease (N=53)

STUDY TREATMENT

Randomized to either continue DPA maintenance dose, or be switched to CUVRIOR

SAFETY OUTCOMES

  • No serious adverse events were reported with CUVRIOR vs. 3 with DPA
  • The most common adverse events (>5%) with CUVRIOR included abdominal pain, change of bowel habits, rash, alopecia, and mood swings

COMMON ADVERSE REACTIONS FROMa CLINICAL STUDY OF CUVRIOR IN ADULT PATIENTS WITH WILSON DISEASE

Adverse Reaction CUVRIOR (N=26)
n(%)		 Penicillamine (N=27)
n(%)
Abdominal painb 5 (19%) 1 (4%)
Change of bowel habitsc 4 (15%) 0
Rashd 3 (12%) 0
Alopecia 2 (8%) 1 (4%)
Mood swings 2 (8%) 0
Figure adapted from CUVRIOR Prescribing Information 1,2

a Adverse reactions that occurred in >5% of CUVRIOR-treated patients and greater than in patients who continued to receive penicillamine.
b Adominal pain is composed of several similar terms.
c Includes constipation, abnormal feces, soft feces.
d Rash is composed of several similar terms.

TRIUMPH Trial Safety Results 3

CUVRIOR demonstrated a well-tolerated safety profile in the randomized, single-center, crossover TRIUMPH trial

STUDY POPULATION

Healthy volunteers aged 18-45 years (N=26)*

STUDY TREATMENT

Randomized to either receive CUVRIOR (TETA 4HCl) or TETA 2HCl (trientine dihydrochloride)

SAFETY OUTCOMES

  • 19 subjects (73.1%) reported at least one treatment emergent adverse event, most commonly gastrointestinal (n=9, 34.6%)
  • The most common single adverse event was headache, but all adverse events were mild in intensity and resolved during the study
  • No serious adverse events occurred during the study
*3 participants withdrew prematurely from the study due to personal reasons.

References:

  1. Schilsky M L, et al. Lancet Gastroenterol Hepatol. 2022;7(12):1092-1102.
  2. CUVRIORTM (trientine tetrahydrochloride) Prescribing Information.
  3. Weiss K H, et al. Eur J Drug Metab Pharmacokinet. 2021;46(5):665-675.

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