TRIENTINE TETRAHYDROCHLORIDE Drug Interactions: What You Need to Know

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 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.

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 )

AND PRECAUTIONS 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 Worsening of Clinical Symptoms at Initiation of Therapy Worsening of clinical symptoms, including neurological deterioration, may occur at the beginning of CUVRIOR therapy due to mobilization of excess stores of copper. Adjust the dosage or discontinue CUVRIOR if the patient&apos;s clinical condition worsens. Evaluate serum non-ceruloplasmin copper (NCC) levels when initiating CUVRIOR treatment, after 3 months of treatment and approximately every 6 months thereafter . Therapy may also be monitored periodically (every 6 to 12 months) with measurement of 24-hour urinary copper excretion (UCE) <span class="opacity-50 text-xs">[see Dosage and Administration (2.4) ]</span>.

5.2 Copper Deficiency Copper deficiency may develop following treatment with CUVRIOR. Close monitoring for manifestations of copper deficiency is required particularly when copper requirements may change, such as in pregnancy, where appropriate control of copper levels are required to ensure proper growth and mental development <span class="opacity-50 text-xs">[see Dosage and Administration (2.4) and Use in Specific Populations (8.1) ]</span> .

5.3 Iron Deficiency Iron deficiency may develop following treatment with CUVRIOR, especially in menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson&apos;s disease. If necessary, iron may be given in short courses, but at least two hours should elapse between administration of CUVRIOR and iron <span class="opacity-50 text-xs">[see Drug Interactions (7.1) and Use in Specific Populations (8.1) ]</span>.

5.4 Hypersensitivity Reactions Hypersensitivity reactions, characterized by rash, have been reported with the use of trientine.

In Trial

1, rash was reported in 12% (3/26) of CUVRIOR-treated patients, and one of these patients discontinued CUVRIOR because of the rash [see Adverse Reactions (6.1) ]. If a patient develops a rash or other hypersensitivity reaction during treatment with CUVRIOR, assess clinically and consider discontinuing CUVRIOR [see Contraindications (4) ] .