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Cuvrior Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Cuvrior Indications
Indications
Wilson’s disease, in patients who are de-coppered and tolerant to penicillamine.
Cuvrior Dosage and Administration
Adult
Swallow whole. Take on an empty stomach. Discontinue penicillamine prior to initiation. Start at 300–3000mg/day in 2 equally divided doses; max 3000mg/day. Adjust total daily dose based on clinical response and serum non-ceruloplasmin copper (NCC) levels. If the number of tabs per day cannot be equally divided, then divide the total daily dose such that the higher number of tabs is given with the first daily dose. Switching from other trientine products: see full labeling.
Children
Cuvrior Contraindications
Not Applicable
Cuvrior Boxed Warnings
Not Applicable
Cuvrior Warnings/Precautions
Warnings/Precautions
Not substitutable on a mg-per-mg basis with other trientine products. Potential worsening of clinical symptoms (including neurological deterioration) at therapy initiation; adjust dose or discontinue if condition worsens. Assess serum NCC levels at initiation, after 3 months, and every 6 months thereafter; may also monitor periodically (every 6–12 months) with 24-hour urinary copper analysis. Monitor for iron deficiency (esp. menstruating or pregnant women) or copper deficiency (eg, in pregnancy). Evaluate and consider discontinuing if rash or other hypersensitivity reactions develop. Elderly. Pregnancy. Nursing mothers.
Cuvrior Pharmacokinetics
Absorption
The median time to the peak concentration (Tmax): ranged from 1.25–2 hours.
Mean (± SD) maximum plasma concentrations (Cmax): 2030±981 ng/mL (after 900 mg dose), and 3430±1480 ng/mL (after 1500 mg dose).
Elimination
Renal. Half-life: 13.8–16.5 hours.
Cuvrior Interactions
Interactions
Avoid concomitant mineral supplements (eg, iron, zinc, calcium, magnesium); if unavoidable, give Cuvrior at least 2hrs before or after an iron supplement, and at least 1hr before or 2hrs after other mineral supplements. Separate dosing of any other drug, food, or milk by at least 1 hour.
Cuvrior Adverse Reactions
Adverse Reactions
Abdominal pain, change of bowel habits, rash, alopecia, mood swings; copper deficiency, iron deficiency, lupus, hypersensitivity reactions.
Cuvrior Clinical Trials
See Literature
Cuvrior Note
Not Applicable
Cuvrior Patient Counseling
See Literature
