Teva has announced the release of a generic version of Syprine (trientine hydrochloride) capsules, 250 mg, as a substitute treatment for Wilson’s disease in the United States.
Wilson’s disease is a genetic condition that results in the accumulation of copper in the body. While some copper is necessary from food to stay healthy, a buildup can cause damage to the liver, brain and eyes.
Symptoms of Wilson’s disease include chronic liver disease, central nervous system abnormalities, and psychiatric disturbances. Other characteristics include jaundice, swelling of the legs and abdomen, and a rust colored ring around the cornea of the eye.
In women, Wilson’s disease can cause menstrual period irregularities, anemia and increased risk of miscarriage and infertility.
Approximately 1 in 30,000 individuals are diagnosed with Wilson’s disease. If not diagnosed in a timely manner, patients can experience severe brain damage and liver failure.
While the condition can be treated with penicillamine, trientine hydrochloride capsules are a substitute treatment for patients who are intolerant of the drug.
“The launch of trientine hydrochloride capsules illustrates Teva’s commitment to serving patient populations in need—whether it’s a medicine that could be taken by millions of individuals, or one focused on a rare condition disorder like Wilson’s disease,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva, in a press release
Trientine hydrochloride capsules should be taken with water on an empty stomach at least one hour before a meal or two hours after a meal and at least one hour apart from any other drug, food, or milk. Patients can take Syprine up to 4 times daily.
The drug should only be used in the treatment of patients who are unable to take penicillamine or when penicillamine is no longer effective in managing the disease.
“Trientine hydrochloride capsules were included on the FDA’s recent publication of a list of off-patent, off-exclusivity branded drugs without approved generics,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D, Teva, in a press release
. “Teva filed our ANDA more than two years ago and we are pleased that the FDA has now approved our applications and we are able to offer a lower-cost generic alternative to patients. We look forward to working closely with the FDA on their review of our many other generic applications.”
Teva also recommends that patients continue to stay in contact with their physicians and to report any side effects of the trientine hydrochloride capsules, including fever, rash, or uncontrollable muscle spasms or contractions.