Prescribing Information
Important Safety Information
Patient Site

Quick Start Program

Quick
Start Program

Orphalan may provide eligible patients with access to medication at no cost for a limited time while coverage through their insurance plan is pursued.
Any questions regarding the Quick Start Program, please contact a Navigator Program Care Coordinator at 1-877-995-ORPH (6774)!
CUVRIOR Co Pay Assistance ProgramContact A Coordinator
Quick Start Eligibility Criteria include that the patient:
  1. Is over 18 years of age
  2. Has received a valid prescription for CUVRIOR with a dosage in line with the FDA-approved label
  3. Is being treated for a valid diagnosis in line with the FDA-approved label
  4. Has active insurance with a submitted Prior Authorization
  5. Has not previously taken CUVRIOR
 
 

 

 

If eligible, a patient may receive up to two one-month supplies of medication while ongoing approval is pursued through their insurance plan. Additional terms and conditions may apply.
Getting your patients enrolled in the Quick Start program:

Step 1: Complete the CUVRIOR Start Form

Step 2: Obtain patient consent to participate in the Navigator Program - consent can be submitted by the HCP along with the completed Start Form or the Care Coordinator can work with the patient to obtain the necessary authorization

Step 3: Submit Prior Authorization to the patient’s insurance plan

Indication & Important Safety Information

CUVRIOR is a copper chelator indicated for the treatment of adult patients with stable Wilson Disease who are de-coppered and tolerant to penicillamine. Please see full Prescribing Information.
Important Safety Information
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

Please see full Prescribing Information

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