What is Repso - leflunomide?
Repso is a medicine that contains the active substance leflunomide. The medicine is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Repso is a "generic medicine", ie it is similar to a "reference medicine" already authorized in the European Union (EU) called Arava.
What is Repso used for - leflunomide?
Repso is used for the treatment of adults with active rheumatoid arthritis (an immune system disease that causes inflammation of the joints) or active psoriatic arthritis (a disease that causes red and scaly patches on the skin and inflammation of the joints).
The medicine can only be obtained with a prescription.
How is Repso - leflunomide used?
Repso treatment should be started and supervised by a specialist who is an expert in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor will prescribe blood tests to check the liver, white blood cell count and platelet count of the patient before prescribing Repso and during treatment at regular intervals.
Repso treatment begins with a "loading dose" of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is between 10 and 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. Usually the medicine begins to take effect after four to six weeks. Its effect can further improve for up to six months.
How does Repso - leflunomide work?
The active substance in Repso, leflunomide, is an immunosuppressant. This substance reduces inflammation by decreasing the production of immune cells called "lymphocytes", which are responsible for the inflammation itself. Leflunomide exerts this action by inhibiting an enzyme called "dihydroorotate dehydrogenase", which is necessary for the lymphocytes to multiply. With less lymphocytes the inflammation is less pronounced, which helps to control the symptoms of arthritis.
What studies have been performed on Repso - leflunomide?
Because Repso is a generic medicine, studies in patients have been limited to tests to prove its bioequivalence to the reference medicine, Arava. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks associated with Repso - leflunomide?
Because Repso is a generic medicine and is bioequivalent to the reference medicine, it is considered to have the same benefits and risks as the reference medicine.
Why has Repso - leflunomide been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Repso has been shown to have comparable quality and to be bioequivalent to Arava. Therefore, it is the opinion of the CHMP that, as in the case of Arava, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Leflunomide Teva.
More information on Repso - leflunomide
On March 14, 2011, the European Commission granted Teva Pharma BV a marketing authorization for Repso, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.
