Prescribing CUVRIOR

The convenience of twice-daily dosing for  long-term maintenance therapy.1

Take CUVRIOR on an empty stomach (at least 1 hour before meals or 2 hours after meals and at least 1 hour apart from any other food, milk, or oral medication).

Actor portrayal

Getting your patient started on CUVRIOR

2 simple options to initiate treatment

Download and complete the CUVRIOR Start Form to begin prescribing

The preferred method of starting CUVRIOR is with the Start Form.This form serves as your patient’s prescription and enrolls them in the Navigator Program^TM. This enrollment allows the pharmacy to identify which offerings the patient may be eligible for.^a

^aPatient consent may be required for certain program offerings.

Submit an eRX through your electronic medical record system

Specialty Pharmacy: PANTHERx Rare Pharmacy

NPI: 1316213531 or 1750843314

Address: 1120 Stevenson Mill Road, Suite 400 Coraopolis, PA 15108

Note: Submitting an eRX does not enroll your patient in the Navigator Program^TM.

CUVRIOR is only available through PANTHERx Rare Pharmacy.

Dosing & Administration

Convenient twice-daily dosing for long-term maintenance therapy1

No refrigeration provides on-the-go potential.¹

The starting total daily dosage of CUVRIOR in adults ranges from 300 mg to 3000 mg orally in divided doses taken just 2 times a day.¹

Administer CUVRIOR¹ on an empty stomach:

at least 1 hour before meals
or 2 hours after meals
at least 1 hour apart from any other food, milk, or oral medication
swallow tablets without crushing, chewing, or dissolving tablets

Supplied in a portable blister pack.2

Tablets are scored so they can be divided in half if needed.

Tablets are smaller than most other maintenance options.2-5

Considering switching a patient to CUVRIOR?

Use this to calculate a conversion between your patient's current dose and CUVRIOR.

Switching from:

DPA

Other trientine

Zinc

There is no standard conversion from zinc.

The recommended starting total daily dosage of CUVRIOR in adult patients is 300 mg up to 3000 mg taken orally in divided doses (two times daily).

Switching from DPA¹

DPA should be discontinued before starting CUVRIOR. Use the table in the CUVRIOR Prescribing Information to find the recommended starting total daily dose of CUVRIOR when switching a patient from DPA.

Switching from other trientine products¹

If switching a patient from a trientine hydrochloride formulation to CUVRIOR, note that the content of the trientine base is not the same and is not substitutable on a milligram-per-milligram basis.

2HCI: 250 mg = 167 mg of trientine base

CUVRIOR: 300 mg = 150 mg of trientine base

Adjust the total daily dosage of CUVRIOR according to clinical assessment and serum non-ceruloplasmin copper (NCC) levels.

Evaluate serum 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).

See Important Safety Information below.

Switching from zinc¹

There is no standard conversion from zinc.

Adjust the total daily dosage of CUVRIOR according to clinical assessment and serum non-ceruloplasmin copper (NCC) levels. Evaluate serum 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) (see Important Safety Information below).

If the number of CUVRIOR tablets prescribed per day cannot be equally divided among doses, then divide the total daily dosage such that the higher number of tablets is administered with the first daily dose. Table 2 provides the recommended approach to administration of CUVRIOR tablets to achieve the total daily dosage.

The Navigator Program™  could help.

The Navigator Program™ is a no-cost program available to eligible patientsb prescribed CUVRIOR that provides access support throughout the entire treatment journey. Learn more about the program and enroll your patients today.

bEnrollment and financial assessment required to confirm eligibility.

Learn More

REFERENCES

1. CUVRIOR [package insert]. Chicago, IL: Orphalan SA. 2. CUVRIOR-trientine tetrahydrochloride tablet, film coated. National Library of Medicine website. Accessed September 5, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f73feeae-62ad-401e-b9f7-5cb269127750 3. GALZIN-zinc acetate tablet capsule. National Library of Medicine website. Accessed September 5, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0c72bff-20f3-4241-b966-34a95178d1a3 4. CUPRIMINE-penicillamine capsule. National Library of Medicine website. Accessed September 5, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80e736d3-2017-4d68-94b4-38255c3c59c6  5. SYPRINE-trientine hydrochloride capsule. National Library of Medicine website. Accessed September 5, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c34f77a7-996b-4470-b5df-d946a7fe5dbe

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.

To report SUSPECTED ADVERSE REACTIONS, contact Orphalan at 1-800-961-8320 or FDA at 1-800-FDA-1088 or  www.fda.gov/medwatch.

Please see full Prescribing Information.