Active Substance: leflunomide
Common Name: leflunomide
ATC Code: L04AA13
Marketing Authorisation Holder: Teva B.V.
Active Substance: leflunomide
Authorisation Date: 2011-03-14
Therapeutic Area: Arthritis, Rheumatoid Arthritis, Psoriatic
Pharmacotherapeutic Group: Immunosuppressants
Leflunomide is indicated for the treatment of adult patients with:
- active rheumatoid arthritis as a ‘disease-modifying antirheumatic drug’ (DMARD);
- active psoriatic arthritis.
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.
Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
What is Repso?
Repso is a medicine that contains the active substance leflunomide. It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Repso is a ‘generic medicine’. This means that Repso is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Arava.
What is Repso used for?
Repso is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
The medicine can only be obtained with a prescription.
How is Repso used?
Repso treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient’s liver, white-blood-cell counts and platelet counts before prescribing Repso, and regularly during treatment.
Repso treatment starts with a ‘loading dose’ of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up to six months.
How does Repso work?
The active substance in Repso, leflunomide, is an immunosuppressant. It reduces inflammation by reducing the production of immune cells called ‘lymphocytes’, which are responsible for inflammation. Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase’, which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
How has Repso been studied?
Because Repso is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks of Repso?
Because Repso is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Why has Repso been approved?
The CHMP concluded that, in accordance with EU requirements, Repso has been shown to have comparable quality and to be bioequivalent to Arava. Therefore, the CHMP’s view was that, as for Arava, the benefit outweighs the identified risk. The Committee recommended that Repso be given marketing authorisation.
Other information about Repso
The European Commission granted a marketing authorisation valid throughout the European Union for Repso to Teva Pharma B.V. on 14 March 2011. The marketing authorisation is valid for five years, after which it can be renewed.
For more information about treatment with Repso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency