cuvrior

Recommended Dosage and Administration Starting total daily dosage of CUVRIOR in adults is 300 mg up to 3,000 mg orally in divided doses (2 times daily). See full prescribing information for recommended conversion table when switching from penicillamine to CUVRIOR. ( 2.1 ) Total daily dosage of CUVRIOR should not exceed 3,000 mg. ( 2.1 ) If the number of CUVRIOR tablets prescribed per day cannot be equally divided among doses, then divide total daily dosage such that the higher number of tablets is taken with the first daily dose. ( 2.1 ) Take CUVRIOR on an empty stomach. ( 2.2 ) Swallow tablets without crushing, chewing, or dissolving tablets. ( 2.2 ) Switching from Other Trientine Products CUVRIOR is not substitutable on a milligram-per-milligram basis with other trientine products. ( 2.3 ) See full prescribing information for additional information on switching from other trientine products. ( 2.3 ) Clinical Monitoring and Laboratory Monitoring of Copper Adjust CUVRIOR dosage according to clinical assessment and laboratory monitoring of copper. ( 2.4 ) See full prescribing information for monitoring recommendations. ( 2.4 ) 2.1 Recommended Dosage and Administration The recommended starting total daily dosage of CUVRIOR in adult patients is 300 mg up to 3,000 mg taken orally in divided doses (two times daily). Table 1 provides the recommended starting total daily dosage of…

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 ) To report SUSPECTED ADVERSE REACTIONS, contact Orphalan at 1-800-961-8320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common Adverse Reactions Table 3 presents common adverse reactions over a 24-week period from Trial 1, a prospective, randomized, multi-center study that was conducted in adult patients with Wilson's disease who were de-coppered and tolerant to penicillamine [see Clinical Studies (14) ] . Patients were either switched to receive CUVRIOR (N=26) or continued to receive penicillamine (N=27). Table 3: Common Adverse Reactions Adverse reactions that occurred in >5% of…

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 )

Occasional cases of trientine overdose have been reported. A large overdose of 60 g of trientine hydrochloride (equivalent to 80 g CUVRIOR) resulted in nausea, vomiting, dizziness, mild acute kidney injury, mild hypophosphatemia, low serum zinc, and low serum copper. The patient recovered following intravenous hydration and supportive measures. There is no antidote for trientine acute overdose. Chronic use of trientine hydrochloride at dosages above the maximum recommended dosage has resulted in sideroblastic anemia.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

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 from any other oral drug. ( 2.2 , 7.1 ) 7.1 Mineral Supplements and Other Oral Drugs CUVRIOR has the potential to chelate non-copper cations in mineral supplements and other oral drugs, and could be rendered ineffective prior to systemic absorption. Mineral Supplements Avoid concomitant use of mineral supplements such as iron, zinc, calcium, or magnesium with CUVRIOR because they may reduce the absorption of CUVRIOR. However, if iron deficiency develops [see Warnings and Precautions (5.3) ], iron supplementation may be given in short courses, but because iron and CUVRIOR each inhibit absorption of the other, administer CUVRIOR at least 2 hours before or 2 hours after administration of an iron supplement [see Dosage and Administration (2.2) ]. If concomitant use of other mineral supplements is unavoidable, administer CUVRIOR at least 1 hour before or 2 hours after administration of other mineral supplements. Other Drugs for Oral Administration Administer CUVRIOR at least 1 hour apart from any other oral drug.