Cufence
Authorised
This medicine is authorised for use in the European Union
trientine dihydrochloride
MedicineHumanAuthorised
Overview
Cufence is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage. Cufence is used in patients who cannot take D-penicillamine, another medicine for this condition.
Cufence contains the active substance trientine dihydrochloride.
Cufence can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Cufence is available as 200 mg capsules. The recommended daily dose is 4 to 8 capsules in adults, and 2 to 5 capsules in children. The capsules are taken in 2 to 4 divided doses. Doses are adjusted according to patient response and levels of copper in the body. Cufence should be taken on an empty stomach, at least one hour before or two hours after meals.
For more information about using Cufence, see the package leaflet or contact your doctor or pharmacist.
The active substance in Cufence, trientine, is a chelating agent. It works by attaching to copper in the body and forming a complex that is then eliminated in the urine and faeces.
The active substance in Cufence, trientine, has been shown to improve symptoms of liver and neurological disease in patients with Wilson's disease who could no longer take D-penicillamine.
In a study of medical records of 77 patients treated with trientine for at least six months, symptoms of liver disease improved in almost half (49%) of the patients treated, and neurological symptoms improved in 14% of the patients. A small proportion of patients had deteriorating symptoms: 5% with worsening liver symptoms and 3% with worsening neurological symptoms.
The most common side effect with Cufence (which may affect up to 1 in 10 people) is nausea (feeling sick), especially when starting treatment. Skin rash may affect up to 1 in 100 people. Duodenitis (inflammation of the duodenum, the part of the gut leading out of the stomach) and severe colitis (inflammation in the large bowel causing pain and diarrhoea) have also been reported. In some patients, neurological deterioration can occur at the start of the treatment, with symptoms such as dystonia (involuntary muscle contractions), stiffness, tremor (shaking) and dysarthria (difficulty speaking).
For the full list of side effects and restrictions of Cufence, see the package leaflet.
Trientine has been used for over 30 years to treat patients with Wilson's disease. Although D-penicillamine is the main treatment for this condition, trientine is effective at improving the symptoms of liver and neurological disease in patients who cannot take this medicine. The safety of Cufence has been shown to be similar to that of other trientine medicines.
The European Medicines Agency therefore decided that Cufence’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Cufence will conduct a study to further characterise the effectiveness of trientine in the treatment of Wilson’s disease, including its effect on the associated liver, neurological or psychiatric symptoms and what the dose should be during early treatment.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cufence have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Cufence are continuously monitored. Side effects reported with Cufence are carefully evaluated and any necessary action taken to protect patients.
Cufence received a marketing authorisation valid throughout the EU on 25 July 2019.
This overview was last updated in 09-2022.
Product information
Latest procedure affecting product information: R/0016
16/05/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Cufence
- Active substance
- trientine dihydrochloride
- International non-proprietary name (INN) or common name
- trientine dihydrochloride
- Therapeutic area (MeSH)
- Hepatolenticular Degeneration
- Anatomical therapeutic chemical (ATC) code
- A16A
Pharmacotherapeutic group
Other alimentary tract and metabolism productsTherapeutic indication
Cufence is indicated for the treatment of Wilson’s disease in patients intolerant to D-Penicillamine therapy, in adults and children aged 5 years or older.
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