ARAVA TABLET 100 MG [SIN11401P]

Product Info

ARAVA TABLET 100 MG

[SIN11401P]

Indications
ARAVA is indicated for treatment of adult patients with:

1. Active rheumatoid arthritis to improve physical function,

2. Active psoriatic arthritis

Regarding the use of ARAVA 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.

Dosage and administration
Dosage in adults above 18 years of age
Initiation of treatment by a physician experienced in the therapy of rheumatoid diseases and psoriatic arthritis is advisable. Special monitoring measures must be followed before initiation and during course of treatment (see “Monitoring Requirement” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
In rheumatoid arthritis: Leflunomide therapy is usually started with a loading dose of one ARAVA 100 mg tablet once daily for 3 days. The recommended maintenance dose is one ARAVA 10 mg tablet to one ARAVA 20 mg tablet once daily depending on the severity (activity) of the disease.
In psoriatic arthritis: leflunomide therapy is started with a loading dose of one ARAVA 100mg tablet once daily for 3 days. The recommended maintenance dose is one 20 mg once daily. An improvement in the rheumatoid condition usually occurs after 4 to 6 weeks and it may further improve up to 4 to 6 months. Treatment with non-steroidal anti-inflammatory drugs and/or corticosteroids may be continued when starting ARAVA.
No dosage adjustment recommended in patients with mild renal insufficiency. No dosage adjustment is required in patients above 65 years of age.
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.

Method of administration
ARAVA film-coated tablets should be swallowed without chewing and with a sufficient amount of liquid (approximately 1/2 glass).
They may be taken together with or independent of a meal.

Special populations
Leflunomide is not recommended in patients less than 18 years of age as it had not been studied in this age group.

Contraindications
ARAVA must not be taken by patients with

• Hypersensitivity to the active substance (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients (see “Composition” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Hypersensitivity to teriflunomide

• Severe deficiency of the immune system (e.g. in AIDS)

• Significant impairment of the bone marrow function or a marked decrease in the number of red or white blood cells (anaemia or leucopenia/neutropenia) or of platelets (thrombocytopenia), due to causes other than rheumatoid or psoriatic arthritis

• Serious infections

• Impairment of liver function

• Severe excessive reduction in blood protein concentration (hypoproteinemia) due, e.g., to a certain renal disease (nephrotic syndrome).

• Moderate to severe renal insufficiency, since available clinical experience is insufficient

• In pregnant women or in women of child-bearing potential who do not use reliable contraception.
  This applies during treatment and after treatment discontinuation, as long as the plasma levels of the active metabolite are above 0.02mg/l (see “Pregnancy and lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Pregnancy must be excluded before start of the treatment.

• In breast-feeding women since leflunomide and metabolites may pass into breast milk (see “Pregnancy and lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).