Leflunomide is an isoxazole immunosuppressant agent which inhibits dihydroorotate dehydrogenase (an enzyme involved in de novo pyrimidine synthesis) and hasantiproliferative activity.
|Pack size||Box of 30 tablets. Bottle of 30 tablets.|
|Dosage forms and strengths||Film-coated tablet: 20 mg|
Treatment of active rheumatoid arthritis in adults, active psoriatic arthritis.
- Start with an oral loading dose of 5 tablets once daily for 3 days.
- The maintenance dose: ½ – 1 tablet once daily (rheumatoid arthritis); 1 tablet once daily (psoriatic arthritis).
- The therapeutic effect usually starts after 4 to 6 weeks of therapy and further improvements may occur for up to 6 months.
- Patients with hepatic impairment: ½ tablet daily.
Orally administered and without regard to meals.
Known hypersensitivity to any of the active substance or excipients.
Patients with hepatic impairment.
Women who are or may become pregnant.
Common: Hypertension, gastrointestinal disturbances (diarrhoea), weight loss, headache, dizziness, nausea, vomiting, mouth ulcer, leucopenia, asthenia, paraesthesia, joint disorders and synovitis, upper respiratory-tract infections, alopecia, eczema, and dry skin. Hypersensitivity reactions (Stevens-Johnson syndrome, erythema multiform, toxic epidermal necrolysis, or vasculitis).
Hepatotoxicity, sometimes can cause fatal. Pancreatitis, interstitial lung disease, and severe infections, including fatal sepsis. Renal failure.
Leflunomide is not recommended for patients with severe immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections; significant hepatic impairment or evidence of infection with hepatitis B or C viruses.
If a patient taking leflunomide develops Stevens-Johnson syndrome, leflunomide therapy should be stopped, and a drug elimination procedure is recommended.
The risk of malignancy, particularly lymphoproliferative disorders, is increased with the use of some immunosuppression medications.
The possibility that adverse effects or drug interactions associated with the drug could continue to occur even though the patient is no longer receiving leflunomide should be considered.
Interstitial lung disease is a potentially fatal disorder, which may occur acutely at any time during therapy with leflunomide.
Leflunomide should be used with caution in patients with renal impairment.
Patients should be aware of how they react to drug before driving or operating machinery.