PANTHERx® Rare Announces Release of CUVRIOR™ (trientine tetrahydrochloride) to Treat Wilson Disease

PITTSBURGH, April 19, 2023 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce the launch of CUVRIOR to treat stable Wilson Disease in adults who are de-coppered and able to take penicillamine.

"We are pleased to add CUVRIOR to the list of PANTHERx® medications. The PANTHERx team works hard to make a positive difference in the lives of our patients who are dealing with devastating and debilitating diseases and CUVRIOR is yet another way we can make an impact," said Rob Snyder, president of PANTHERx® Rare.

Wilson Disease is a rare genetic disorder caused by a mutation in the ATP7B gene, resulting in the accumulation of copper throughout the body. Copper deposits in the body lead to a wide array of symptoms including, but not limited to tremors, anxiety, jaundice due to liver injury, and Kayser-Fleischer rings (brown rings in the corneas of the eyes). Untreated, Wilson Disease can be fatal. Serious complications include problems with the liver, kidneys, neurological (e.g., tremors, clumsy gait, speech difficulties), psychological (e.g., depression, psychosis) and blood problems (anemia, jaundice).

CUVRIOR is an innovative oral formulation of the active ingredient trientine created by Orphalan to treat adult patients with stable Wilson Disease who have already been de-coppered. CUVRIOR works by chelating copper in the body to decrease copper absorption and increase urinary copper excretion. In clinical trials, CUVRIOR was found to be well tolerated and non-inferior to penicillamine in reducing non-ceruloplasmin copper (NCC) levels in Wilson Disease patients.

About PANTHERx Rare

PANTHERx Rare is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. Although the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an FDA-approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.

PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy (NASP) and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care (ACHC). PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.

IMPORTANT SAFETY INFORMATION

 Do not use CUVRIOR if you are allergic to trientine or to any of the ingredients in CUVRIOR.

• Your Wilson's Disease symptoms could get worse when you start treatment. This could happen because too much copper is removed from the body in a short period of time. Your doctor may need to reduce your dose or stop CUVRIOR treatment.
• Copper deficiency may develop following treatment with CUVRIOR. Your doctor will do tests to monitor your urine and blood for copper. 
• Iron deficiency may develop while taking CUVRIOR. If this happens, your doctor may tell you to take iron supplements for a limited time.
• Allergic reactions, such as a rash can occur. If a rash or other allergic reaction occurs, stop taking CUVRIOR and get emergency medical help.
• The most common side effects are pain in the abdomen, change in bowel habits, rash, hair loss (alopecia), and mood swings.

Take CUVRIOR at least 1 hour apart from any other oral medicine. Tell your doctor about all the medicines you're taking, including over-the-counter medicines, vitamins, and herbal supplements. Avoid taking supplements when taking CUVRIOR. Taking CUVRIOR with mineral supplements (e.g., iron, zinc, calcium, magnesium) can reduce the effectiveness of CUVRIOR. If iron supplementation is necessary, take CUVRIOR at least 2 hours before or 2 hours after taking iron; for other mineral supplements (e.g., zinc, calcium, magnesium), take CUVRIOR at least 1 hour before or 2 hours after. Do not start or stop any medicines while taking CUVRIOR without talking to your doctor.

These are not all the possible side effects of CUVRIOR. You are encouraged to report negative side effects of prescription drugs. Contact Orphalan at 1-800-961-8320 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

Please see full Prescribing Information.

03/2023 US-ORPH-CUVR-023* - Orphalan reviewed and approved this material exclusively regarding CUVRIOR, Wilson disease and Orphalan related information and claims.

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SOURCE PANTHERx Rare Pharmacy