Leflunomida Generis (Leflunomide)

Leflunomide is a disease-modifying antirheumatic drug indicated for inflammatory joint disorders.

• Rheumatoid arthritis: reduces joint inflammation and slows disease progression.
• Psoriatic arthritis: may improve skin and joint symptoms in adult patients.
• Inflammatory arthritis (off‑label): helps control disease activity across various forms of adult inflammatory arthritis.

• Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated lymphocytes, thereby reducing the immune‑mediated inflammatory response that drives joint damage in rheumatoid and related arthritides.

Leflunomide may cause a range of adverse reactions, from mild to serious.

Common Side Effects

• Diarrhoea: mild to moderate gastrointestinal upset.
• Nausea: occasional feeling of sickness.
• Alopecia: reversible hair thinning.
• Rash: skin irritation or erythema.
• Elevated liver enzymes: asymptomatic increase in hepatic markers.
• Hypertension: rise in blood pressure readings.

Serious or Rare Side Effects

• Severe liver injury: jaundice, hepatic failure.
• Bone marrow suppression: neutropenia, anaemia, thrombocytopenia.
• Pulmonary toxicity: interstitial lung disease, dyspnoea.
• Stevens‑Johnson syndrome: severe skin reactions.
• Severe infections: opportunistic bacterial or viral infections.
• Teratogenicity: fetal malformations if exposure occurs during pregnancy.

Patients receiving Leflunomida Generis should be monitored closely for safety concerns.

• Liver function monitoring: perform baseline and periodic liver enzyme tests.
• Blood pressure checks: monitor for hypertension throughout therapy.
• Pregnancy avoidance: drug is contraindicated in pregnancy (Category X).
• Breastfeeding restriction: avoid use while nursing.
• Contraception requirement: use effective contraception during treatment and for several months after discontinuation.
• Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Leflunomida Generis can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

• Warfarin: increased anticoagulant effect and bleeding risk.
• Live vaccines: heightened risk of infection due to immunosuppression.
• Strong CYP1A2 inhibitors (e.g., fluoroquinolones): may raise lefuno­midide plasma levels.
• Cholesterol‑binding resins (e.g., cholestyramine): reduce drug absorption.
• Immunosuppressive biologics: additive immunosuppression leading to infection.

Moderate Interactions (Monitor Closely)

• NSAIDs: combined hepatotoxic potential.
• ACE inhibitors: possible additive hypertension.
• Statins: increased risk of myopathy.
• Oral contraceptives: reduced efficacy, consider alternative methods.
• Allopurinol: higher incidence of rash and hypersensitivity reactions.