Product image of Leflunomide Aurobindo (Leflunomide) supplied by GNH India

Leflunomide Aurobindo

Active Ingredient:
Leflunomide
Origin:
EU

Leflunomide Aurobindo (Leflunomide)

Leflunomide, the active ingredient in Leflunomide Aurobindo, is an immunomodulatory agent presented as an oral tablet for oral use. It is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis and juvenile idiopathic arthritis in adult and pediatric patients where disease‑modifying therapy is required.

GNH India supplies Leflunomide Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aurobindo Pharma (Italia) S.R.L.

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Indications & Clinical Uses

Leflunomide is a disease‑modifying antirheumatic drug that targets inflammatory pathways in autoimmune arthritis.

  • Rheumatoid arthritis: reduces joint inflammation and slows structural damage.
  • Psoriatic arthritis: improves skin lesions and joint symptoms.
  • Juvenile idiopathic arthritis: controls disease activity and prevents functional impairment.

How It Works

  • Leflunomide inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, which blocks de novo pyrimidine synthesis. This limits the proliferation of activated lymphocytes, thereby reducing the autoimmune response that drives joint inflammation in rheumatoid, psoriatic and juvenile idiopathic arthritis.

Side Effects

Leflunomide may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhoea: mild to moderate gastrointestinal upset.
  • Nausea and vomiting: transient digestive discomfort.
  • Alopecia: reversible hair thinning.
  • Rash or pruritus: skin irritation.
  • Elevated liver enzymes: mild hepatic enzyme rise.
  • Hypertension: increase in blood pressure readings.

Serious or Rare Side Effects

  • Severe liver injury: hepatitis or hepatic failure.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis: life‑threatening skin reactions.
  • Bone marrow suppression: pancytopenia or severe neutropenia.
  • Interstitial lung disease: progressive pulmonary fibrosis.
  • Serious infections: opportunistic bacterial or viral infections.
  • Teratogenicity: fetal malformations when exposure occurs in pregnancy.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline health status and monitor for specific risks.

  • Liver function monitoring: obtain baseline tests and repeat periodically.
  • Blood pressure assessment: check regularly and manage hypertension.
  • Pregnancy avoidance: contraindicated in pregnancy; ensure effective contraception.
  • Infection vigilance: screen for active infections and avoid live vaccines.
  • Drug‑specific counseling: inform patients about potential hair loss and gastrointestinal upset.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Leflunomide can alter the effect of several co‑administered medicines, requiring careful management.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect, risk of bleeding.
  • Methotrexate: additive hepatotoxicity and bone‑marrow suppression.
  • Azathioprine: heightened risk of severe cytopenias.

Moderate Interactions (Monitor Closely)

  • CYP2C9 inhibitors (e.g., fluconazole): may raise leflunomide plasma levels.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): potential for increased liver enzyme elevation.
  • Live vaccines: reduced efficacy and higher infection risk.

Frequently Asked Questions

Leflunomide Aurobindo is a disease‑modifying antirheumatic drug indicated for the management of rheumatoid arthritis, psoriatic arthritis and juvenile idiopathic arthritis. It helps reduce joint inflammation, prevent structural damage, and improve functional outcomes in patients with these autoimmune conditions.

Leflunomide blocks the enzyme dihydroorotate dehydrogenase, which is essential for de novo pyrimidine synthesis. By limiting pyrimidine production, the drug suppresses the proliferation of activated T‑lymphocytes, thereby dampening the autoimmune response that drives inflammation in arthritic diseases.

The specific dose of leflunomide is determined by the prescribing clinician based on the patient’s condition, age, renal and hepatic function, and other individual factors. Physicians typically start with a loading dose followed by a maintenance dose, but the exact regimen should be confirmed with the prescriber.

Leflunomide is classified as pregnancy category X because it is known to cause fetal malformations. It is contraindicated in pregnancy, and women of child‑bearing potential must use effective contraception. The drug is also not recommended while breastfeeding, as it may be excreted in milk.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Leflunomide and methotrexate are both conventional DMARDs, but they differ in mechanism and safety profile. Leflunomide targets pyrimidine synthesis, whereas methotrexate inhibits folate metabolism. Leflunomide may be preferred when methotrexate is poorly tolerated, but it carries a higher risk of liver toxicity and teratogenicity, requiring careful monitoring.

Leflunomide Aurobindo should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture, excessive heat and direct sunlight. Keep the container tightly closed and out of reach of children.

Leflunomide Aurobindo is taken orally, usually as a tablet swallowed whole with water. It is typically administered once daily, but the exact schedule and any dose adjustments must be directed by the prescribing healthcare professional.

The most serious risks include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome, bone‑marrow suppression leading to pancytopenia, interstitial lung disease, and teratogenic effects. Patients should report symptoms like jaundice, unexplained bruising, persistent cough or rash to their physician promptly.

Leflunomide is contraindicated in pregnant women, patients with severe liver disease, uncontrolled hypertension, active infections, or known hypersensitivity to the drug. It should also be avoided in individuals planning pregnancy without effective contraception and in those with a history of severe skin reactions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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