CUVRIOR

AbsorptionThe pharmacokinetic profile has been evaluated in healthy subjects following single oral administration of up to 1,500 mg CUVRIOR under fasting conditions. The median time to the peak concentration (T max ) of trientine ranged from 1.25 to 2 hours. Mean (± standard deviation) maximum plasma concentrations (C max ) after 900 mg and 1,500 mg CUVRIOR were 2030±981, and 3430±1480 ng/mL, respectively. The systemic exposure (AUC) of trientine increased in a dose proportional manner over the...

The effectiveness of CUVRIOR for the treatment of adult patients with stable Wilson's disease who are decoppered and tolerant to penicillamine was demonstrated in a phase 3 trial (Trial 1). In addition, the safety and effectiveness of CUVRIOR in Wilson's Disease is further supported by studies of another trientine product in patients intolerant to penicillamine. Trial 1 was a randomized, active-controlled, multi-center, non-inferiority study (NCT03539952) conducted in 53 adult patients with Wilson's disease. The objective was to compare treatment with CUVRIOR to treatment with penicillamine. A...

The following clinically significant adverse reactions are described elsewhere in the labeling: Potential for Worsening of Clinical Symptoms at Initiation of Therapy [see Warnings and Precautions (5.1) ] Copper Deficiency [see Warnings and Precautions (5.2) ] Iron Deficiency [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (>5%) are abdominal pain, change of bowel habits, rash, alopecia, and mood swings. ( 6.1 ) ...

CUVRIOR is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in CUVRIOR [see Warnings and Precautions (5.4) ] . Hypersensitivity to trientine or to any of the excipients in CUVRIOR. ( 4 )

Potential for Worsening of Clinical Symptoms at Initiation of Therapy : May include neurological deterioration. Adjust dosage or discontinue CUVRIOR if clinical condition worsens. ( 5.1 ) Copper Deficiency : Periodic monitoring is required. ( 5.2 ) Iron Deficiency : If iron deficiency develops, a short course of iron supplementation may be given. ( 5.3 , 7.1 ) Hypersensitivity Reactions : If rash or other hypersensitivity reaction occurs, consider discontinuing CUVRIOR. ( 5.4 ) 5.1 Potential for...

7 DRUG INTERACTIONS Mineral Supplements (e.g. iron, zinc, calcium, magnesium): Avoid concomitant use. If concomitant use is unavoidable ( 2.2 , 7.1 ): Iron : Take CUVRIOR at least 2 hours before or 2 hours after iron. Other Mineral Supplements : 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 f...