BAGEDA FILM-COATED TABLET 20MG [SIN17108P]

Product Info

BAGEDA FILM-COATED TABLET 20MG

[SIN17108P]

4.1 Therapeutic indications
BAGEDA is indicated for treatment of adult patients with:

1. Active rheumatoid arthritis to improve physical function,

2. Active psoriatic arthritis

Regarding the use of BAGEDA in patients recently pre-treated with DMARDs (disease modifying antirheumatic drug) which are toxic for the liver (hepatotoxic) or for the blood (haematotoxic) and patients for whom substitution with another DMARD is planned, see “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Switching from leflunomide to another DMARD without following the elimination procedure may also increase risk of serious adverse reactions even for a long time after switching.

4.2 Posology and method of administration
This product should be prescribed by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis. Special monitoring measures must be followed before initiation and during course of treatment (See “Monitoring Requirement”).

Posology/frequency and duration of administration:

• In rheumatoid arthritis: BAGEDA therapy is usually started with a loading dose of 100 mg once daily for 3 days. The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.

• In psoriatic arthritis: BAGEDA therapy is started with a loading dose of 100 mg once daily for 3 days. The recommended maintenance dose is leflunomide 20 mg once daily.

An improvement in the rheumatoid condition usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months. Treatment with non-steroidal anti-inflammatory drugs and/or corticosteroids may be continued when starting BAGEDA.

Method of administration:
BAGEDA film-coated tablets should be swallowed without chewing and with a sufficient amount of liquid (approximately 120ml). They may be taken with or without food.

Monitoring Requirement
Similar to other currently available medicines (e.g. methotrexate) for treatment of RA, patients on BAGEDA will need to do some blood test during BAGEDA treatment. This is to monitor their health conditions and to ensure that they are doing fine with the BAGEDA treatment.

ALT (SGPT), AST and complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment & during treatment period. The schedule of blood test for patients will be once every 2 weeks during the first 6 months of treatment. Subsequently, the frequency of the blood tests will be reduced to once in 2 months and thereafter.

Additional information relating to specific populations
Due to the prolonged half-life of the active metabolite of leflunomide, patients should be carefully observed after dose reduction, since it may take several weeks for metabolite levels to decline.

Renal failure
There is no dose adjustment recommended in patients with mild renal insufficiency.

Pediatric population
Leflunomide is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see Section 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric population
No dosage adjustment is required in patients above 65 years of age.

4.3 Contraindications

• Patients with hypersensitivity (especially previous Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to leflunomide, to the principal active metabolite teriflunomide or to any of the excipients (see Section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe immunodeficiency states, e.g. patients with AIDS.

• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.

• Patients with serious infections (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.

• Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.

Hepatoxicity:
It is contra indicated in patients with impairment of liver function.
Pregnancy:
Pregnant women, or women of childbearing potential who are not using reliable contraception
during treatment with leflunomide and thereafter as long as the plasma levels of the active
metabolite are above 0.02 mg/l (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Pregnancy must be excluded before starting
of treatment with leflunomide (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Women in lactation period should not breast feed during leflunomide use (see Section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).