PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Leflunomide Teva?
Leflunomide Teva is a medicine containing leflunomide as an active ingredient and is available as tablets (white round 10 mg; dark beige 20 mg triangular).
Leflunomide Teva is a "generic" medicine which means that Leflunomide Teva is similar to a "reference medicine" already authorized in the European Union (EU) called Arava.
What is Leflunomide Teva used for?
Leflunomide Teva is used to treat adults with active rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints).
The medicine can only be obtained with a prescription.
How is Leflunomide Teva used?
Leflunomide Teva therapy should be started and supervised by a specialist experienced in the treatment of rheumatoid arthritis. The doctor must perform blood tests to check the patient's liver, white blood cell and platelet counts before prescribing Leflunomide Teva, and regularly during treatment.
Treatment with Leflunomide Teva should be started with a "loading dose" of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10-20 mg once a day. Usually the medicine begins to take effect after four to six weeks. The effect can further improve up to six months.
How does Leflunomide Teva work?
The active substance in Leflunomide Teva, leflunomide, is an immunosuppressant. This substance reduces inflammation by reducing the production of immune cells called "lymphocytes", which are responsible for inflammation. Leflunomide exerts this action by blocking an enzyme called "dihydroorotate dehydrogenase", which is necessary for the lymphocytes to multiply. With less lymphocytes, inflammation is reduced and the symptoms of arthritis are controlled.
What studies have been performed on Leflunomide Teva?
Because Leflunomide Teva is a generic medicine, studies in patients have been limited to checking that it is bioequivalent to the reference medicine, Arava. Two drugs are bioequivalent if, once in the body, they deliver the same levels of active ingredient.
What are the risks and benefits of Leflunomide Teva?
Since Leflunomide Teva is a generic medicine and is bioequivalent to the reference medicine, it is believed that the benefits and risks associated with it are the same as the reference medicine.
Why has Leflunomide Teva been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in line with EU requirements, it was shown that Leflunomide Teva is qualitatively comparable and bioequivalent to Arava and therefore considered that, as in the case of Arava, the benefits outweigh the risks identified. The Committee recommended the granting of a marketing authorization for Leflunomide Teva.
Other information on Leflunomide Teva
On March 10, 2011, the European Commission granted a marketing authorization for Leflunomide Teva, valid throughout the European Union, to TEVA Pharma BV. This authorization is valid for five years and is renewable.
Last update of this summary: 01-2011.
